CLINICAL TRIAL UPDATE

DRY AMD
► Study: Age-Related Eye Disease Study II (AREDS II) Sponsor: National Eye Institute Status: Enrolling patients Purpose: Investigate the effects of oral supplements of lutein/zeaxanthin and omega-3 fatty acids for the treatment of AMD. A secondary randomization will further refine the AREDS-type supplement by testing a lower dose of zinc and eliminating beta-carotene Design: Phase 3, Randomized, Prospective, Multicenter Trial Number of Patients: 4000 Number of Clinical Centers: 80 plus Inclusion Criteria: Age 55 years to 80 years; bilateral large drusen (>125 μm) or advanced AMD (neovascular AMD or geographic atrophy involving the center of fovea) in 1 eye only and presence of large drusen in the fellow eye Exclusion Criteria: Choroidal neovascularization (CNV) associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, other confounding ocular disease or surgical procedures (except for cataract surgery or YAG laser) Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120 ► Study: Measuring Reading Rehabilitation Outcomes Sponsor: Dept. of Veterans Affairs Status: Enrolling patients Purpose: To measure the effectiveness of a newly designed oculomotor training program for patients with AMD Design: Educational, Counseling, Training, Nonrandomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study Number of Patients: 90 Inclusion Criteria: Established preferred retinal locus; VA of ≤20/70 and ≥20/400 (in the better eye) Exclusion Criteria: Major ophthalmologic and neurologic disease; choroidal neovascularization ("wet" AMD); moderate to severe media opacities; and cognitive impairment Information: (312) 996-1466 ► Study: Effects of Sun Filters on Age-Related Macular Degeneration in People With Lens Implants Sponsor: National Institute of Child Health and Human Development (NICHD) Status: Currently enrolling Purpose: To test a new method for preventing worsening of AMD and for developing imaging methods to follow the very earliest microscopic changes in the disease Design: Natural History, Longitudinal, Defined Population, Prospective Study Number of Patients: 40 Inclusion Criteria: Patients will be local area residents who average greater than or equal to 2 hours outdoors daily, who are willing to follow the protocol of wearing bicolor sunglasses whenever outdoors in daylight, to keep a log book of use, and to return periodically to NIH for noninvasive imaging studies Exclusion Criteria: Wet AMD; prior eye disorders; diabetes or current chemotherapy Information: (800) 411-1222 ► Study: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration Sponsor: The New York Eye and Ear Infirmary Status: Currently enrolling Purpose: To investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone, which had been proven as a safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Dry AMD in 1 or both eyes; age 50 or above of either gender Exclusion Criteria: Known sensitivity to mannitol or copaxone; skin disease or active infection of skin; active fever or active treatment for infection; history of other uncontrolled systemic active disease; premenopausal females not using reliable birth control; sensitivity to fluorescein or iodine Information: ktai@nyee.edu ► Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration Sponsor: Ocular Transplantation; National Neurovision Research Institute Status: Currently enrolling Purpose: To show that retinal transplantation can help to prevent blindness and restore eyesight in patients with dry AMD Design: Treatment, Nonrandomized, Open-label, Active Control, Factorial Assignment, Safety/Efficacy Study Number of Patients: 10 Inclusion Criteria: The subject must have decreased central VA of 20/200 or worse in 1 eye by ETDRS vision testing for a duration of at least 1 year in the operated eye and have the diagnosis of AMD; vision in the nonoperated eye must be better than the operated eye. Vision in the operated eye cannot be better than 20/200; subject is older than 55 years of age; patient has undergone microperimetry and Goldmann visual field testing Exclusion Criteria: Patient having central visual acuity of better than 20/200 in 1 eye by ETDRS or vision worse than 20/200 in 1 eye by ETDRS for a duration of less than 1 year; patient under 55 years of age; patient having medical problems that are contraindicatory for short-term anesthesia; features of any condition other than AMD in the study eye (such as pathologic myopia or presumed ocular histoplasmosis) associated with choroidal neovascularization; any significant ocular disease (other than choroidal neovascularization) that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; inability to obtain photographs to document choroidal neovascularization, including difficulty with venous access; history of choroidal neovascularization in the study eye; participating in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment; prior photodynamic therapy or Macugen therapy for choroidal neovascularization; patient who has a history of uveitis, Coat"s disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole Information: nradtke@prodigy.net

DRY AMD

► Study: Age-Related Eye Disease Study II (AREDS II)
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: Investigate the effects of oral supplements of lutein/zeaxanthin and omega-3 fatty acids for the treatment of AMD. A secondary randomization will further refine the AREDS-type supplement by testing a lower dose of zinc and eliminating beta-carotene
Design: Phase 3, Randomized, Prospective, Multicenter Trial
Number of Patients: 4000
Number of Clinical Centers: 80 plus
Inclusion Criteria: Age 55 years to 80 years; bilateral large drusen (>125 μm) or advanced AMD (neovascular AMD or geographic atrophy involving the center of fovea) in 1 eye only and presence of large drusen in the fellow eye
Exclusion Criteria: Choroidal neovascularization (CNV) associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, other confounding ocular disease or surgical procedures (except for cataract surgery or YAG laser)
Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120

► Study: Measuring Reading Rehabilitation Outcomes
Sponsor: Dept. of Veterans Affairs
Status: Enrolling patients
Purpose: To measure the effectiveness of a newly designed oculomotor training program for patients with AMD
Design: Educational, Counseling, Training, Nonrandomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Number of Patients: 90
Inclusion Criteria: Established preferred retinal locus; VA of ≤20/70 and ≥20/400 (in the better eye)
Exclusion Criteria: Major ophthalmologic and neurologic disease; choroidal neovascularization ("wet" AMD); moderate to severe media opacities; and cognitive impairment
Information: (312) 996-1466

► Study: Effects of Sun Filters on Age-Related Macular Degeneration in People With Lens Implants
Sponsor: National Institute of Child Health and Human Development (NICHD)
Status: Currently enrolling
Purpose: To test a new method for preventing worsening of AMD and for developing imaging methods to follow the very earliest microscopic changes in the disease
Design: Natural History, Longitudinal, Defined Population, Prospective Study
Number of Patients: 40
Inclusion Criteria: Patients will be local area residents who average greater than or equal to 2 hours outdoors daily, who are willing to follow the protocol of wearing bicolor sunglasses whenever outdoors in daylight, to keep a log book of use, and to return periodically to NIH for noninvasive imaging studies
Exclusion Criteria: Wet AMD; prior eye disorders; diabetes or current chemotherapy
Information: (800) 411-1222

► Study: Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-Related Macular Degeneration
Sponsor: The New York Eye and Ear Infirmary
Status: Currently enrolling
Purpose: To investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone, which had been proven as a safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD
Design: Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Dry AMD in 1 or both eyes; age 50 or above of either gender
Exclusion Criteria: Known sensitivity to mannitol or copaxone; skin disease or active infection of skin; active fever or active treatment for infection; history of other uncontrolled systemic active disease; premenopausal females not using reliable birth control; sensitivity to fluorescein or iodine
Information: ktai@nyee.edu

► Study: Safety Study in Retinal Transplantation for Dry Age-Related Macular Degeneration
Sponsor: Ocular Transplantation; National Neurovision Research Institute
Status: Currently enrolling
Purpose: To show that retinal transplantation can help to prevent blindness and restore eyesight in patients with dry AMD
Design: Treatment, Nonrandomized, Open-label, Active Control, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: The subject must have decreased central VA of 20/200 or worse in 1 eye by ETDRS vision testing for a duration of at least 1 year in the operated eye and have the diagnosis of AMD; vision in the nonoperated eye must be better than the operated eye. Vision in the operated eye cannot be better than 20/200; subject is older than 55 years of age; patient has undergone microperimetry and Goldmann visual field testing
Exclusion Criteria: Patient having central visual acuity of better than 20/200 in 1 eye by ETDRS or vision worse than 20/200 in 1 eye by ETDRS for a duration of less than 1 year; patient under 55 years of age; patient having medical problems that are contraindicatory for short-term anesthesia; features of any condition other than AMD in the study eye (such as pathologic myopia or presumed ocular histoplasmosis) associated with choroidal neovascularization; any significant ocular disease (other than choroidal neovascularization) that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; inability to obtain photographs to document choroidal neovascularization, including difficulty with venous access; history of choroidal neovascularization in the study eye; participating in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment; prior photodynamic therapy or Macugen therapy for choroidal neovascularization; patient who has a history of uveitis, Coat"s disease, diabetic retinopathy, glaucoma, or a cataract that prevents visualization of the posterior pole
Information: nradtke@prodigy.net

WET AMD
► Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD Sponsor: OSI/Pfizer Status: Enrolling patients Purpose: To explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment Number of Patients: 1000 Inclusion Criteria: Patients must have 1, but not more than 3, prior treatments for neovascular AMD Information: (866) 622-8436 ► Study: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD Sponsor: Vitreous Retina Macula Consultants of New York; Genentech Status: Enrolling patients Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization Design: Treatment, Nonrandomized, Open-label, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 15 Inclusion Criteria: BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye; evidence that CNV extends under the geometric center of the foveal avascular zone; area of the CNV must occupy at least 50% of the total lesion; lesion must be ≤4000 μm in greatest linear dimension (GLD) Exclusion Criteria: History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea; angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>6 D), or CNV secondary to causes other than AMD; receiving or require chronic concomitant therapy with systemic (>5 mg) or ocular corticosteroids Contact: (212) 452-6902 ► Study: Study to Determine Safety/Efficacy of Lucentis for Treatment of Retinal Angiomatous Proliferation Secondary to AMD Sponsor: The National Retina Institute/Genentech Status: Enrolling patients Purpose: To determine the safety and efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to AMD Number of Patients: 20 Inclusion Criteria: Age >50 years; definite characteristic signs of AMD, including drusen; presence of retinal angiomatous proliferation as determined by clinical signs (intraretinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on FA, hot spot on static ICG, visible RAP lesion on high speed ICG) Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye; treatment with verteporfin in the nonstudy eye less than 7 days preceding day 0; previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.); previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0; history of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye; previous participation in any studies of investigational drugs within 1 month preceding day 0 (excluding vitamins and minerals) Contact: (301) 986-8747 ► Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration Sponsor: Novartis/Greater Houston Retinal Research Status: Currently enrolling Purpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMD Design: Treatment, Randomized, Openlabel, Dose-comparison, Parallel Assignment, Efficacy Study Number of Patients: 30 Inclusion Criteria: Age >55 years; subfoveal neovascular membrane confirmed by FA and/or ICG; VA not better than 20/32 and not worse than 20/320 by ETDRS refraction Exclusion Criteria: Previous vitrectomy; intracapsular cataract extraction; previous treatment with ranibizumab, bevacizumab, triamcinolone, or PDT; history of retinal detachment; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study; prior enrollment in any study for AMD Information: http://www.houstonretina.com/ ► Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Sponsor: Novartis Status: Currently enrolling Purpose: To evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with CNV secondary to AMD Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 318 Inclusion Criteria: Subjects of either gender age 50 years or older; subfoveal CNV due to AMD Exclusion Criteria: Choroidal neovascularization due to causes other than AMD; prior treatment for neovascular AMD in the study eye Information: Brandi Teske, bteske@westcoastretina.com ► Study: A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD Sponsor: Quark Biotech, Inc. Status: Enrolling patients Purpose: To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection Design: Treatment, Non-random ized, Open-label, Uncontrolled, Single Group Assignment, Safety Study Number of Patients: 42 Inclusion Criteria: Documented CNV secondary to AMD; clear ocular media and adequate pupil dilation; IOP ≤25 mm Hg; retinal thickness >250 μm by OCT; BCVA not better than 20/200 Exclusion Criteria: Women of childbearing potential; CNV due to causes other than AMD; underlying disease or other disease of the eye; therapy for AMD in either eye in last 30 days; steroid therapy for AMD in last 6 months; history of intraocular surgery other than cataract surgery or of retinal detachment in the study eye Information: (212) 452-6902 ► Study: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMD Sponsor: Barnes Retina Institute Status: Enrolling patients Purpose: To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with Visudyne Study Design: Treatment, Randomized, Open-Label, Active Control, Single Group Assignment, Safety/Efficacy Study Inclusion Criteria: Treatment-naive patients with active, subfoveal, exudative AMD; VA of 20/40 to 20/320 in the study eye; subfoveal CNV must be at least 50% of the total lesion size; total area of lesion components other than CNV must be less than 50% of the total lesion size; lesion must be <5400 μm in greatest linear dimension; lesion size <10 disc areas Exclusion Criteria: Previous treatment for CNV with anti-VEGF agents, intraocular steroids, and/or PDT with Visudyne; geographic atrophy or fibrosis in the study eye; intraocular surgery within 6 weeks of enrollment; subretinal hemorrhage >50% of the total lesion; intraocular pressure greater than 30 mm Hg on 2 pressure-lowering medications; severe disciform scarring; advanced glaucoma; allergies to porfins or a known hypersensitivity to any component of Visudyne; porphyria, pregnancy, or lactation Information: bristudies@barnesretina institute.com ► Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration Sponsor: Potentia Pharmaceuticals, Inc. Status: Currently enrolling Purpose: To provide initial safety and tolerability information for a larger phase 2 study of intravitreal POT-4 and for phase 1 studies of POT-4 slow-release formulations for treatment of patients with AMD. Design: Prospective, Uncontrolled, Nonrandomized, Single-masked, Single-dose Escalation Study Number of Patients: 18 Inclusion Criteria: Age ≥50 years; in the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 μm and presence of a choroidal neovascular lesion, either predominantly or minimally classic or occult with no classic in nature, determined by the Digital Angiography Reading Center (DARC) with the CNV defined by its FA features; lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself; visual acuity of 20/100 or worse in the study eye as measured on an ETDRS chart Exclusion Criteria: Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant DME, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; cataract surgery within 3 months of enrollment; presence of hemorrhage greater than 50% of the CNV lesion; history of treatment for CNV in the study eye, peribulbar corticosteroid injection within 6 months prior to the start of the trial, or oral steroid use at any time during the 30 days prior to randomization; intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization; medical problems that make consistent follow-up over the treatment period unlikely (eg, stroke, severe MI, endstage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections; history of coronary artery disease or cerebral vascular disease; hypersensitivity to fluorescein Information: federico@potentiapharma.com ► Study: A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD Sponsor: Oregon Health and Science University Status: Currently enrolling Purpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment Design: Treatment, Nonrandomized, Openlabel, Uncontrolled, Single Group Assignment, Efficacy Study Number of Patients: 300 Inclusion Criteria: Age >50 years; study eye must never have received treatment for neovascular AMD; visual acuity in treatment eye must be between 20/30 and 20/320 (ETDRS) Exclusion Criteria: Choroidal neovascularization not from AMD; concomitant non-AMD related maculopathy in study eye; active treatment for neovascular AMD in fellow eye; acuity loss or central field loss from non-AMD cause; pigment epithelial detachment without evidence of CNV; individuals in whom Lucentis is contraindicated; pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception Information: (503) 494-3616 ► Study: CABERNET: Study of Strontium90 Beta Radiation With Lucentis to Treat AMD Sponsor: NeoVista Status: Enrolling patients Purpose: To evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal CNV associated with wet AMD. Design: Treatment, Randomized, Openlabel, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 450 Inclusion Criteria: Must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of <12 total disc areas (21.24 mm2), and a GLD ≥5.4 mm; must be age 50 or older Exclusion Criteria: Prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic antiangiogenic or intravitreal antiangiogenic agents in study eye; previous radiation therapy to the eye, head, or neck; diagnosis of diabetes Information: (510) 933-7650, info@neovistainc.com ► Study: COBALT: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD Sponsor: Opko Health, Inc. Status: Currently enrolling Purpose: To compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pretreatment with 3 injections of Lucentis compared to Lucentis given every 4 weeks to people with wet AMD. Patients will be assigned at random to receive 1 of 3 treatments options for 104 weeks Design: Treatment, Randomized, Doubleblind, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 330 Inclusion Criteria: Age ≥50 years old; predominantly classic, minimally classic or occult with no classic lesions secondary to AMD; ETDRS BCVA of 69 to 24 letters (20/40 to 20/320 Snellen equivalent) Exclusion Criteria: Any intraocular surgery of the study eye within 12 weeks of screening; previous posterior vitrectomy of the study eye; advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment Information: clinicaltrials@opko.com ► Study: Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-Related Macular Degeneration Sponsor: University of California, Davis/Genentech Status: Currently enrolling Purpose: To determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe Design: Natural History, Longitudinal, Defined Population, Prospective Study Inclusion Criteria: Age >50 years; women must be postmenopausal without a period for at least 1 year; Hgb A1C <6; VA 20/60 to 20/400; lesion size <12 disc area; submacular hemorrhage less than 75% of total lesion; submacular fibrosis less than 25% of total lesion Exclusion Criteria: PDT within 3 months; anti-VEGF therapy within 6 weeks; intravitreal or sub-Tenon"s Kenalog within 6 months; intraocular surgery within 3 months or expected in the next 6 months; other concurrent retinopathy or optic neuropathy Information: (916) 734-6303 ► Study: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1) Sponsor: Regeneron/Bayer Status: Currently enrolling Purpose: To study the efficacy and safety of VEGF-Trap-Eye in patients with neovascular AMD. Design: Treatment, Randomized, Doubleblind, Active-control, Parallel Assignment Number of Patients: 1200 Inclusion Criteria: Men and women ≥50 years of age; active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye; ETDRS BCVA of 20/40 to 20/320 (letter score of 73 to 25) in the study eye Exclusion Criteria: Any prior treatment with anti-VEGF agents; total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye; subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded 270° by visible CNV); scar or fibrosis, making up >50% of total lesion in the study eye; scar, fibrosis, or atrophy involving the center of the fovea Information: vegf.trap@regeneron.com ► Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD Sponsor: Jerini Ophthalmic Status: Currently enrolling Purpose: To determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin 5 1-antagonist is absorbed, broken down, and eliminated from the body when it is given as a single dosage strength by injection into the eye Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety Study Number of Patients: 36 Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal CNV due to AMD; total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≥12 DA, of which at least 50% must be active CNV; for patients with occult or nonclassic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of 3 or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks; clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening; intraocular pressure of 21 mm Hg or less; retinal thickness ≥250 μm by OCT. Exclusion Criteria: Any prior PDT in the study eye; previous therapeutic radiation to the eye; any retinovascular disease or retinal degeneration other than AMD; serous pigment epithelial detachment without the presence of neovascularization; presence of pigment epithelial tears or rips; previous posterior vitrectomy or retinal surgery; any periocular infection in the past 4 weeks Information: (919) 226-1440 ×325 ► Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST) Sponsor: Retina Vitreous Associates, P.C.; Genentech Status: Currently enrolling Purpose: To test the safety, tolerability and effectiveness of a higher dose (1.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with agerelated macular degeneration who have never been treated with ranibizumab. Design: Treatment, Randomized, Open Label, Parallel Assignment Number of Patients: 30 Inclusion Criteria: Treatment naive macular degeneration patients with CNV; >50 years old; visual acuity 20/40 to 20/320 Exclusion Criteria: Pregnancy or previous history of thromboembolic event including myocardial infarction or stroke Information: cawh@aol.com ► Study: Sensitivity of the Home Macular Perimeter (HMP) Sponsor: Notal Vision Ltd Status: Currently enrolling Purpose: To estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD Design: Cohort, Prospective Number of Patients: 20 Inclusion Criteria: Subjects with AMD related lesions: New onset (up to 60 days) nontreated CNV; age >50 years; VA with habitual correction >20/200 in study eye; familiar with computer usage Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye; presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA; any non-macular-related ocular surgery performed within 3 months prior to study entry in the targeted eye; inability to tolerate intravenous FA; participation in another study with the exclusion of AREDS study Information: osnat@notalvision.com ► Study: A Study to Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD Sponsor: GlaxoSmithKline Status: Currently enrolling Purpose: To evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients Design: Treatment, Randomized, Doubleblind, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study Number of Patients: 60 Inclusion Criteria: Age-related macular degeneration patients diagnosed with subfoveal CNV in the study eye, with all of the following characteristics required: central subfield thickness >300 μm on investigator-determined OCT (inclusive of subretinal fluid); active subfoveal leakage as determined by investigator-determined FA; minimally classic or occult with no classic CNV lesion; lesion size no greater than 12 disc areas; CNV >50% of lesion area; <50% of lesion area with blood; >25% of lesion area with fibrosis; best-corrected ETDRS VA in the study eye between 80 to 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 to 4/63) at screening Exclusion Criteria: Additional eye disease in the study eye that could compromise BCVA (ie, glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, or retinitis pigmentosa); CNV in the study eye due to other causes unrelated to AMD; presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required); geographic atrophy involving the center of the fovea in the study eye; anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, FA and OCT; vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD; more than 1 prior photodynamic therapy (PDT) treatment in the study eye Information: (877) 379-3718 ► Study: Phase 1, Safety, Tolerability, and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration Sponsor: Ophthotech Corp. Status: Currently enrolling Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD. Design: Treatment, Open-label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 18 Inclusion Criteria: Subfoveal CNV due to AMD Exclusion Criteria: Diabetic retinopathy; history or evidence of severe cardiac disease; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function; stroke (within 12 months of trial entry); any major surgical procedure within 1 month of trial entry. Previous therapeutic radiation in the region of the study eye; any treatment with an investigational agent in the past 60 days for any condition Information: denise.teuber@ophthotech.com ► Study: CATT: Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial Sponsor: National Eye Institute Status: Currently enrolling Purpose: To evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule. Design: Treatment, Randomized, Doubleblind (Caregiver, Investigator, Outcomes Assessor), Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 1200 Inclusion Criteria: Active, subfoveal choroidal neovascularization (CNV); subretinal hemorrhage and fibrosis <50% of total lesion area; VA 20/25 to 20/320; age ≥50 yrs; at least 1 druse (>63 μm) in either eye or late AMD in fellow eye Exclusion Criteria: Previous treatment for CNV in study eye; other progressive retinal disease likely to compromise VA; contraindications to injections with Lucentis or Avastin Information: dan.martin@emory.edu ► Study: Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF Sponsor: CoMentis Status: Currently enrolling Purpose: To study the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab Design: Treatment, Randomized, Doubleblind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 60 Inclusion Criteria: > 55 years of age; clinical diagnosis of neovascular AMD Exclusion Criteria: Confounding ocular condition Information: jmonk@comentis.com ► Study: Study of the Repeat Dosing of Ketoconazole on the Pharmacokinetics of a Single Dose Of Pazopanib (GW786034) Eye Drops Sponsor: GlaxoSmithKline Status: Currently enrolling Purpose: To evaluate the effect of repeat oral dosing of ketoconazole on the pharmacokinetics of single dose pazopanib administered as an eye drop Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study Number of Patients: 24 Inclusion Criteria: Healthy as determined by a trained healthcare professional, base on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with ALT or AST values above the normal limit should be excluded from enrollment; male or female greater than 18 years of age; non-childbearing potential defined as premenopausal females with a documented tubal ligation/occlusion or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample showing simultaneous follicle stimulating hormone >40M IU/mL and estradiol <40 pg/ml (<140 pmol/L) may be used to confirm that a woman is postmenopausal]. BMI within the range 18-30 kg/m2 (inclusive); QTcB or QTcF <450 msec; or QTc <480 msec in subjects with Bundle Branch Block Exclusion Criteria: A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening; HIV requiring treatment during the study period; subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current Study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer); exposure to more than 4 new chemical entities within 12 months prior to the first dosing day; history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation; any contraindication to use of ketoconazole as detailed in the package insert; where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period Information: (877) 379-3718 ► Study: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration Sponsor: National Eye Institute Status: Currently enrolling Purpose: To examine whether the antiinflammatory medicines infliximab, sirolimus or daclizumab, when given with a patient's current therapies, will prevent the growth of new blood vessels in the eye in patients with AMD Design: Treatment, Randomized, Openlabel, Uncontrolled, Parallel Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Age greater than or equal to 55 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; any antiangiogenic therapy in the study eye within 7 days of beginning immunosuppressive therapy; in the study eye, the participant's study eye vision is between 20/20 and 20/400; in the study eye, the presence of choroidal neovascularization under the fovea determined by NEI Investigators; visual acuity of 20/400 or better as measured on an ETDRS chart. Exclusion Criteria: Choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; presence of geographic atrophy under the fovea in the study eye; evidence of retinal angiomatous proliferation as suspected by the presence of intraretinal hemorrhage, intraretinal leakage, adjoining serous PED or the presence of a connecting retinal vessel; presence of a chorioretinal anastomosis; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear (rip) of the RPE; a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy; presence of fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion; history of other systemic antiangiogenic treatment or treatment for CNV (not including photodynamic therapy and pegaptanib sodium injections) in the study eye with transpupillary thermotherapy or other local treatment (such as submacular surgery); participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in 1 or more extraocular organ systems for which a defined effective medical regimen is indicated; participant with a corneal melting, necrotizing keratitis, or impending vision loss Information: (800) 411-1222 ► Study: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration Sponsor: Allergan Status: Currently enrolling Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with anti-VEGF treatment vs anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration Design: Treatment, Randomized, Doubleblind (Subject, Caregiver, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 200 Inclusion Criteria: >50 years old with subfoveal CNV secondary to AMD; VA between 20/40 and 20/400 in the study eye Exclusion Criteria: Any intraocular surgery within 3 months; glaucoma or cataract; high IOP; uncontrolled systemic disease Information: clinicaltrials@allergan.com ► Study: The MAP Study: FA/Medidur for AMD Pilot Sponsor: Johns Hopkins University/Alimera Sciences Status: Currently enrolling Purpose: To compare the safety of 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau Design: Treatment, Randomized, Singleblind (Subject), Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Patients age 50 or greater; treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4-6 weeks apart) with no improvement in VA (worse or within one line better) or center subfield thickening (worse or within 30 μm better); best-corrected visual acuity 20/320 or better in the study eye Exclusion Criteria: Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, ie, double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD); glaucoma or ocular hypertension (defined as IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents) in the study eye; laser or photodynamic therapy within 12 weeks of screening; any ocular surgery in the study eye within 12 weeks of screening; YAG capsulotomy in the study eye within 15 days of screening; treatment with intravitreal, sub Tenon's, or periocular steroid or anti-VEGF therapy other than Lucentis within 6 months prior to enrollment (eg., triamcinolone injection, Avastin, Macugen.) Systemic treatment with Avastin is also not allowed within 6 months prior to screening or at any time during the study Information: ghafiz1@jhmi.edu ► Study: Antioxidant Systems and Age-Related Macular Degeneration Sponsor: Vanderbilt University/National Institutes of Health Status: Currently enrolling Purpose: To determine whether the antioxidant supplements used in AREDS shifted the plasma pool of the AREDS subjects to a more reduced state Design: Case-Only, Prospective Number of Patients: 140 Inclusion Criteria: Age 55-80; intermediate or advanced AMD; willing to give written informed consent, make the required study visits, and follow instructions; any race and either sex Exclusion Criteria: Current history of a medical condition that would preclude scheduled study visits or completion of the study (eg, unstable cardiovascular disease, unstable pulmonary disease, chronic hepatitis, or AIDS); current or history of an ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye (eg, amblyopia, uncontrolled glaucoma with an IOP > 30mm Hg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis); clinical signs of myopic retinopathy, or a refraction of >-8 diopter power in current prescription; aphakic or pseudophakic patients may be enrolled if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the patient's cataract surgery of either myopic retinopathy or a refraction of >-8 D; intraocular surgery in study eye (eye to be treated) within 60 days prior to enrollment; presence of a scleral buckle in the study eye Information: paul.sternberg@vanderbilt.edu ► Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Related Macular Degeneration Sponsor: National Eye Institute (NEI) Status: Currently enrolling Purpose: To use an eye imaging test called high speed indocyanine green angiography (HS-ICG), which examines leaky vessels in the eye, to try to find out why individuals respond differently to ranibizumab (Lucentis) treatment for wet age-related macular degeneration (AMD) Design: Prospective Number of Patients: 50 Inclusion Criteria: Must be 50 years old or older; must be diagnosed with AMD in at least one eye defined by the presence of drusen at least 63 μm in size; must have CNV secondary to AMD as determined by the investigator; must have VA of better than 20/400 in the affected eye as measured on an ETDRS chart Exclusion Criteria: CNV, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; geographic atrophy or fibrosis under the fovea; decreased vision due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis, or epiretinal membrane; additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant DME, severe nonproliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear of the RPE; a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy; history of treatment for CNV in the study eye with verteporfin/photodynamic therapy, transpupillary thermotherapy, external beam radiation therapy, or other local treatment (such as submacular surgery); previous subfoveal focal laser photocoagulation (juxtafoveal or extrafoveal) in the study eye; previous ranibizumab, bevacizumab or pegaptanib sodium treatments in the study or fellow eye less than 4 weeks prior to enrollment; prior verteporfin/photodynamic therapy in the fellow eye less than 1 week prior to enrollment; prior intravitreal or peribulbar corticosteroids in the study or fellow eye less than 12 weeks prior to enrollment; evidence of ocular toxoplasmosis; external ocular infection, including conjunctivitis; chalazion; significant blepharitis; or aphakia in the study eye; history of systemic anti-VEGF therapy less than 4 weeks prior to enrollment or will be starting systemic anti-VEGF therapy while on the protocol; intraocular surgery (including lens replacement surgery) within 6 weeks prior to enrollment; history of (within the last 6 months), or current ocular or periocular infection (including any history of ocular herpes zoster or simplex); prior vitrectomy; history of systemic or topical steroid use at any time during the 30 days prior to enrollment; has participated in any other clinical study or is receiving, or has received any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment; has had insertion of a scleral buckle in the study eye; clinical evidence of scleral thinning (defined as an area of blue/grey discoloration of the sclera representing visualization of underlying choroidal tissue through a thinned area of sclera) seen at the time of external eye examination; exhibits clinical signs of myopic retinopathy, or has a refraction of greater than spherical equivalent -8.00D in their current prescription. Pseudophakic participants may be enrolled in this study if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the participant"s cataract surgery of either myopic retinopathy or a refraction of greater than spherical equivalent -8.00D. Information: prpl@mail.cc.nih.gov

WET AMD

► Study: Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
Sponsor: OSI/Pfizer
Status: Enrolling patients
Purpose: To explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single-group Assignment
Number of Patients: 1000
Inclusion Criteria: Patients must have 1, but not more than 3, prior treatments for neovascular AMD
Information: (866) 622-8436

► Study: Imatinib Mesylate Combined With Intravitreal Ranibizumab in the Treatment of Choroidal Neovascularization Secondary to AMD
Sponsor: Vitreous Retina Macula Consultants of New York; Genentech
Status: Enrolling patients
Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed choroidal neovascularization
Design: Treatment, Nonrandomized, Open-label, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 15
Inclusion Criteria: BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart; CNV lesion of any type in the study eye; evidence that CNV extends under the geometric center of the foveal avascular zone; area of the CNV must occupy at least 50% of the total lesion; lesion must be ≤4000 μm in greatest linear dimension (GLD)
Exclusion Criteria: History of prior PDT, external-beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy in the study eye; atrophy under the center of the fovea; angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>6 D), or CNV secondary to causes other than AMD; receiving or require chronic concomitant therapy with systemic (>5 mg) or ocular corticosteroids
Contact: (212) 452-6902

► Study: Study to Determine Safety/Efficacy of Lucentis for Treatment of Retinal Angiomatous Proliferation Secondary to AMD
Sponsor: The National Retina Institute/Genentech
Status: Enrolling patients
Purpose: To determine the safety and efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to AMD
Number of Patients: 20
Inclusion Criteria: Age >50 years; definite characteristic signs of AMD, including drusen; presence of retinal angiomatous proliferation as determined by clinical signs (intraretinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult leakage on FA, hot spot on static ICG, visible RAP lesion on high speed ICG)
Exclusion Criteria: Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy in the study eye; treatment with verteporfin in the nonstudy eye less than 7 days preceding day 0; previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.); previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0; history of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye; previous participation in any studies of investigational drugs within 1 month preceding day 0 (excluding vitamins and minerals)
Contact: (301) 986-8747

► Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration
Sponsor: Novartis/Greater Houston Retinal Research
Status: Currently enrolling
Purpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMD
Design: Treatment, Randomized, Openlabel, Dose-comparison, Parallel Assignment, Efficacy Study
Number of Patients: 30
Inclusion Criteria: Age >55 years; subfoveal neovascular membrane confirmed by FA and/or ICG; VA not better than 20/32 and not worse than 20/320 by ETDRS refraction
Exclusion Criteria: Previous vitrectomy; intracapsular cataract extraction; previous treatment with ranibizumab, bevacizumab, triamcinolone, or PDT; history of retinal detachment; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study; prior enrollment in any study for AMD
Information: http://www.houstonretina.com/

► Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
Sponsor: Novartis
Status: Currently enrolling
Purpose: To evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with CNV secondary to AMD
Design: Treatment, Randomized, Double-blind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 318
Inclusion Criteria: Subjects of either gender age 50 years or older; subfoveal CNV due to AMD
Exclusion Criteria: Choroidal neovascularization due to causes other than AMD; prior treatment for neovascular AMD in the study eye
Information: Brandi Teske, bteske@westcoastretina.com

► Study: A Phase I Trial of a Single Intravitreal Injection of REDD14NP to Patients With CNV Secondary to Wet AMD
Sponsor: Quark Biotech, Inc.
Status: Enrolling patients
Purpose: To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection
Design: Treatment, Non-random ized, Open-label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 42
Inclusion Criteria: Documented CNV secondary to AMD; clear ocular media and adequate pupil dilation; IOP ≤25 mm Hg; retinal thickness >250 μm by OCT; BCVA not better than 20/200
Exclusion Criteria: Women of childbearing potential; CNV due to causes other than AMD; underlying disease or other disease of the eye; therapy for AMD in either eye in last 30 days; steroid therapy for AMD in last 6 months; history of intraocular surgery other than cataract surgery or of retinal detachment in the study eye
Information: (212) 452-6902

► Study: Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced-Fluence PDT in Patients With Wet AMD
Sponsor: Barnes Retina Institute
Status: Enrolling patients
Purpose: To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with Visudyne
Study Design: Treatment, Randomized, Open-Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Inclusion Criteria: Treatment-naive patients with active, subfoveal, exudative AMD; VA of 20/40 to 20/320 in the study eye; subfoveal CNV must be at least 50% of the total lesion size; total area of lesion components other than CNV must be less than 50% of the total lesion size; lesion must be <5400 μm in greatest linear dimension; lesion size <10 disc areas
Exclusion Criteria: Previous treatment for CNV with anti-VEGF agents, intraocular steroids, and/or PDT with Visudyne; geographic atrophy or fibrosis in the study eye; intraocular surgery within 6 weeks of enrollment; subretinal hemorrhage >50% of the total lesion; intraocular pressure greater than 30 mm Hg on 2 pressure-lowering medications; severe disciform scarring; advanced glaucoma; allergies to porfins or a known hypersensitivity to any component of Visudyne; porphyria, pregnancy, or lactation
Information: bristudies@barnesretina institute.com

► Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration
Sponsor: Potentia Pharmaceuticals, Inc.
Status: Currently enrolling
Purpose: To provide initial safety and tolerability information for a larger phase 2 study of intravitreal POT-4 and for phase 1 studies of POT-4 slow-release formulations for treatment of patients with AMD.
Design: Prospective, Uncontrolled, Nonrandomized, Single-masked, Single-dose Escalation Study
Number of Patients: 18
Inclusion Criteria: Age ≥50 years; in the study eye, diagnosis of exudative AMD defined by the presence of drusen larger than 63 μm and presence of a choroidal neovascular lesion, either predominantly or minimally classic or occult with no classic in nature, determined by the Digital Angiography Reading Center (DARC) with the CNV defined by its FA features; lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself; visual acuity of 20/100 or worse in the study eye as measured on an ETDRS chart
Exclusion Criteria: Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant DME, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; cataract surgery within 3 months of enrollment; presence of hemorrhage greater than 50% of the CNV lesion; history of treatment for CNV in the study eye, peribulbar corticosteroid injection within 6 months prior to the start of the trial, or oral steroid use at any time during the 30 days prior to randomization; intraocular surgery (including lens replacement surgery) within 6 weeks prior to randomization; medical problems that make consistent follow-up over the treatment period unlikely (eg, stroke, severe MI, endstage malignancy), or in general a poor medical risk because of other systemic diseases or active uncontrolled infections; history of coronary artery disease or cerebral vascular disease; hypersensitivity to fluorescein
Information: federico@potentiapharma.com

► Study: A Study of Genetic and Environmental Factors and Their Effect on Response to Treatment With Lucentis (Ranibizumab) for Wet AMD
Sponsor: Oregon Health and Science University
Status: Currently enrolling
Purpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment
Design: Treatment, Nonrandomized, Openlabel, Uncontrolled, Single Group Assignment, Efficacy Study
Number of Patients: 300
Inclusion Criteria: Age >50 years; study eye must never have received treatment for neovascular AMD; visual acuity in treatment eye must be between 20/30 and 20/320 (ETDRS)
Exclusion Criteria: Choroidal neovascularization not from AMD; concomitant non-AMD related maculopathy in study eye; active treatment for neovascular AMD in fellow eye; acuity loss or central field loss from non-AMD cause; pigment epithelial detachment without evidence of CNV; individuals in whom Lucentis is contraindicated; pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception
Information: (503) 494-3616

► Study: CABERNET: Study of Strontium90 Beta Radiation With Lucentis to Treat AMD
Sponsor: NeoVista
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of focal delivery of radiation for the treatment of subfoveal CNV associated with wet AMD.
Design: Treatment, Randomized, Openlabel, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 450
Inclusion Criteria: Must have predominantly classic, minimally classic, or occult with no classic lesions, as determined by the investigator, secondary to AMD, with a total lesion size (including blood, scarring, and neovascularization) of <12 total disc areas (21.24 mm2), and a GLD ≥5.4 mm; must be age 50 or older
Exclusion Criteria: Prior or concurrent subfoveal CNV therapy including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections with Macugen, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT), and systemic antiangiogenic or intravitreal antiangiogenic agents in study eye; previous radiation therapy to the eye, head, or neck; diagnosis of diabetes
Information: (510) 933-7650, info@neovistainc.com

► Study: COBALT: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
Sponsor: Opko Health, Inc.
Status: Currently enrolling
Purpose: To compare the safety and effectiveness of bevasiranib given either every 8 weeks or every 12 weeks after an initial pretreatment with 3 injections of Lucentis compared to Lucentis given every 4 weeks to people with wet AMD. Patients will be assigned at random to receive 1 of 3 treatments options for 104 weeks
Design: Treatment, Randomized, Doubleblind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 330
Inclusion Criteria: Age ≥50 years old; predominantly classic, minimally classic or occult with no classic lesions secondary to AMD; ETDRS BCVA of 69 to 24 letters (20/40 to 20/320 Snellen equivalent)
Exclusion Criteria: Any intraocular surgery of the study eye within 12 weeks of screening; previous posterior vitrectomy of the study eye; advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment
Information: clinicaltrials@opko.com

► Study: Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-Related Macular Degeneration
Sponsor: University of California, Davis/Genentech
Status: Currently enrolling
Purpose: To determine whether treating wet macular degeneration with a combination of Lucentis and proton beam irradiation is safe
Design: Natural History, Longitudinal, Defined Population, Prospective Study
Inclusion Criteria: Age >50 years; women must be postmenopausal without a period for at least 1 year; Hgb A1C <6; VA 20/60 to 20/400; lesion size <12 disc area; submacular hemorrhage less than 75% of total lesion; submacular fibrosis less than 25% of total lesion
Exclusion Criteria: PDT within 3 months; anti-VEGF therapy within 6 weeks; intravitreal or sub-Tenon"s Kenalog within 6 months; intraocular surgery within 3 months or expected in the next 6 months; other concurrent retinopathy or optic neuropathy
Information: (916) 734-6303

► Study: Double-Masked Study of Efficacy and Safety of IVT VEGF Trap-Eye in Subjects With Wet AMD (VIEW 1)
Sponsor: Regeneron/Bayer
Status: Currently enrolling
Purpose: To study the efficacy and safety of VEGF-Trap-Eye in patients with neovascular AMD.
Design: Treatment, Randomized, Doubleblind, Active-control, Parallel Assignment
Number of Patients: 1200
Inclusion Criteria: Men and women ≥50 years of age; active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye; ETDRS BCVA of 20/40 to 20/320 (letter score of 73 to 25) in the study eye
Exclusion Criteria: Any prior treatment with anti-VEGF agents; total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye; subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded 270° by visible CNV); scar or fibrosis, making up >50% of total lesion in the study eye; scar, fibrosis, or atrophy involving the center of the fovea
Information: vegf.trap@regeneron.com

► Study: A Phase 1 Safety Study of Single and Repeated Doses of JSM6427 (Intravitreal Injection) to Treat AMD
Sponsor: Jerini Ophthalmic
Status: Currently enrolling
Purpose: To determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin 5 1-antagonist is absorbed, broken down, and eliminated from the body when it is given as a single dosage strength by injection into the eye
Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 36
Inclusion Criteria: Best-corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal CNV due to AMD; total area of the lesion (including blood, neovascularization and scar/atrophy) must be ≥12 DA, of which at least 50% must be active CNV; for patients with occult or nonclassic CNV; there must be the presence of subretinal hemorrhage (but still comprising no more than 50% of the lesion) and/or documented evidence of 3 or more lines of vision loss (ETDRS or equivalent) during the previous 12 weeks; clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening; intraocular pressure of 21 mm Hg or less; retinal thickness ≥250 μm by OCT.
Exclusion Criteria: Any prior PDT in the study eye; previous therapeutic radiation to the eye; any retinovascular disease or retinal degeneration other than AMD; serous pigment epithelial detachment without the presence of neovascularization; presence of pigment epithelial tears or rips; previous posterior vitrectomy or retinal surgery; any periocular infection in the past 4 weeks
Information: (919) 226-1440 ×325

► Study: Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)
Sponsor: Retina Vitreous Associates, P.C.; Genentech
Status: Currently enrolling
Purpose: To test the safety, tolerability and effectiveness of a higher dose (1.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with agerelated macular degeneration who have never been treated with ranibizumab.
Design: Treatment, Randomized, Open Label, Parallel Assignment
Number of Patients: 30
Inclusion Criteria: Treatment naive macular degeneration patients with CNV; >50 years old; visual acuity 20/40 to 20/320
Exclusion Criteria: Pregnancy or previous history of thromboembolic event including myocardial infarction or stroke
Information: cawh@aol.com

► Study: Sensitivity of the Home Macular Perimeter (HMP)
Sponsor: Notal Vision Ltd
Status: Currently enrolling
Purpose: To estimate the sensitivity of the HMP test in identifying visual field functional defects in subjects with CNV secondary to AMD
Design: Cohort, Prospective
Number of Patients: 20
Inclusion Criteria: Subjects with AMD related lesions: New onset (up to 60 days) nontreated CNV; age >50 years; VA with habitual correction >20/200 in study eye; familiar with computer usage
Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye; presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP, or FA; any non-macular-related ocular surgery performed within 3 months prior to study entry in the targeted eye; inability to tolerate intravenous FA; participation in another study with the exclusion of AREDS study
Information: osnat@notalvision.com

► Study: A Study to Evaluate the Pharmacodynamics, Safety, and Pharmacokinetics of Pazopanib Drops in Adult Subjects With Neovascular AMD
Sponsor: GlaxoSmithKline
Status: Currently enrolling
Purpose: To evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients
Design: Treatment, Randomized, Doubleblind, Uncontrolled, Parallel Assignment, Pharmacokinetics/Dynamics Study
Number of Patients: 60
Inclusion Criteria: Age-related macular degeneration patients diagnosed with subfoveal CNV in the study eye, with all of the following characteristics required: central subfield thickness >300 μm on investigator-determined OCT (inclusive of subretinal fluid); active subfoveal leakage as determined by investigator-determined FA; minimally classic or occult with no classic CNV lesion; lesion size no greater than 12 disc areas; CNV >50% of lesion area; <50% of lesion area with blood; >25% of lesion area with fibrosis; best-corrected ETDRS VA in the study eye between 80 to 24 letters inclusive (approximately 20/25 and 20/320 or 4/5 to 4/63) at screening
Exclusion Criteria: Additional eye disease in the study eye that could compromise BCVA (ie, glaucoma with documented visual field loss, clinically significant diabetic retinopathy, ischemic optic neuropathy, or retinitis pigmentosa); CNV in the study eye due to other causes unrelated to AMD; presence of retinal angiomatous proliferation (RAP) in the study eye, as determined by the investigator (confirmation by indocyanine green angiography is not required); geographic atrophy involving the center of the fovea in the study eye; anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, FA and OCT; vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD; more than 1 prior photodynamic therapy (PDT) treatment in the study eye
Information: (877) 379-3718

► Study: Phase 1, Safety, Tolerability, and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corp.
Status: Currently enrolling
Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD.
Design: Treatment, Open-label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 18
Inclusion Criteria: Subfoveal CNV due to AMD
Exclusion Criteria: Diabetic retinopathy; history or evidence of severe cardiac disease; history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation; clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function; stroke (within 12 months of trial entry); any major surgical procedure within 1 month of trial entry. Previous therapeutic radiation in the region of the study eye; any treatment with an investigational agent in the past 60 days for any condition
Information: denise.teuber@ophthotech.com

► Study: CATT: Comparison of Age-Related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.
Design: Treatment, Randomized, Doubleblind (Caregiver, Investigator, Outcomes Assessor), Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 1200
Inclusion Criteria: Active, subfoveal choroidal neovascularization (CNV); subretinal hemorrhage and fibrosis <50% of total lesion area; VA 20/25 to 20/320; age ≥50 yrs; at least 1 druse (>63 μm) in either eye or late AMD in fellow eye
Exclusion Criteria: Previous treatment for CNV in study eye; other progressive retinal disease likely to compromise VA; contraindications to injections with Lucentis or Avastin
Information: dan.martin@emory.edu

► Study: Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Sponsor: CoMentis
Status: Currently enrolling
Purpose: To study the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab
Design: Treatment, Randomized, Doubleblind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: > 55 years of age; clinical diagnosis of neovascular AMD
Exclusion Criteria: Confounding ocular condition
Information: jmonk@comentis.com

► Study: Study of the Repeat Dosing of Ketoconazole on the Pharmacokinetics of a Single Dose Of Pazopanib (GW786034) Eye Drops
Sponsor: GlaxoSmithKline
Status: Currently enrolling
Purpose: To evaluate the effect of repeat oral dosing of ketoconazole on the pharmacokinetics of single dose pazopanib administered as an eye drop
Design: Treatment, Nonrandomized, Open-label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Number of Patients: 24
Inclusion Criteria: Healthy as determined by a trained healthcare professional, base on a medical evaluation including medical history, physical examination, laboratory tests and 12-lead ECG. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with ALT or AST values above the normal limit should be excluded from enrollment; male or female greater than 18 years of age; non-childbearing potential defined as premenopausal females with a documented tubal ligation/occlusion or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample showing simultaneous follicle stimulating hormone >40M IU/mL and estradiol <40 pg/ml (<140 pmol/L) may be used to confirm that a woman is postmenopausal]. BMI within the range 18-30 kg/m2 (inclusive); QTcB or QTcF <450 msec; or QTc <480 msec in subjects with Bundle Branch Block
Exclusion Criteria: A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening; HIV requiring treatment during the study period; subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current Study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer); exposure to more than 4 new chemical entities within 12 months prior to the first dosing day; history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation; any contraindication to use of ketoconazole as detailed in the package insert; where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56-day period
Information: (877) 379-3718

► Study: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To examine whether the antiinflammatory medicines infliximab, sirolimus or daclizumab, when given with a patient's current therapies, will prevent the growth of new blood vessels in the eye in patients with AMD
Design: Treatment, Randomized, Openlabel, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Age greater than or equal to 55 years; in the study eye, diagnosis of AMD defined by the presence of drusen larger than 63 μm; any antiangiogenic therapy in the study eye within 7 days of beginning immunosuppressive therapy; in the study eye, the participant's study eye vision is between 20/20 and 20/400; in the study eye, the presence of choroidal neovascularization under the fovea determined by NEI Investigators; visual acuity of 20/400 or better as measured on an ETDRS chart.
Exclusion Criteria: Choroidal neovascularization, in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; presence of geographic atrophy under the fovea in the study eye; evidence of retinal angiomatous proliferation as suspected by the presence of intraretinal hemorrhage, intraretinal leakage, adjoining serous PED or the presence of a connecting retinal vessel; presence of a chorioretinal anastomosis; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear (rip) of the RPE; a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy; presence of fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring greater than 50% of the CNV lesion; history of other systemic antiangiogenic treatment or treatment for CNV (not including photodynamic therapy and pegaptanib sodium injections) in the study eye with transpupillary thermotherapy or other local treatment (such as submacular surgery); participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in 1 or more extraocular organ systems for which a defined effective medical regimen is indicated; participant with a corneal melting, necrotizing keratitis, or impending vision loss
Information: (800) 411-1222

► Study: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration
Sponsor: Allergan
Status: Currently enrolling
Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with anti-VEGF treatment vs anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration
Design: Treatment, Randomized, Doubleblind (Subject, Caregiver, Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 200
Inclusion Criteria: >50 years old with subfoveal CNV secondary to AMD; VA between 20/40 and 20/400 in the study eye
Exclusion Criteria: Any intraocular surgery within 3 months; glaucoma or cataract; high IOP; uncontrolled systemic disease
Information: clinicaltrials@allergan.com

► Study: The MAP Study: FA/Medidur for AMD Pilot
Sponsor: Johns Hopkins University/Alimera Sciences
Status: Currently enrolling
Purpose: To compare the safety of 2 doses of FA/Medidur in conjunction with Lucentis (as needed) in patients with neovascular AMD who have have been treated with Lucentis for at least 6 months and have reached a plateau
Design: Treatment, Randomized, Singleblind (Subject), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Patients age 50 or greater; treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4-6 weeks apart) with no improvement in VA (worse or within one line better) or center subfield thickening (worse or within 30 μm better); best-corrected visual acuity 20/320 or better in the study eye
Exclusion Criteria: Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, ie, double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD); glaucoma or ocular hypertension (defined as IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents) in the study eye; laser or photodynamic therapy within 12 weeks of screening; any ocular surgery in the study eye within 12 weeks of screening; YAG capsulotomy in the study eye within 15 days of screening; treatment with intravitreal, sub Tenon's, or periocular steroid or anti-VEGF therapy other than Lucentis within 6 months prior to enrollment (eg., triamcinolone injection, Avastin, Macugen.) Systemic treatment with Avastin is also not allowed within 6 months prior to screening or at any time during the study
Information: ghafiz1@jhmi.edu

► Study: Antioxidant Systems and Age-Related Macular Degeneration
Sponsor: Vanderbilt University/National Institutes of Health
Status: Currently enrolling
Purpose: To determine whether the antioxidant supplements used in AREDS shifted the plasma pool of the AREDS subjects to a more reduced state
Design: Case-Only, Prospective
Number of Patients: 140
Inclusion Criteria: Age 55-80; intermediate or advanced AMD; willing to give written informed consent, make the required study visits, and follow instructions; any race and either sex
Exclusion Criteria: Current history of a medical condition that would preclude scheduled study visits or completion of the study (eg, unstable cardiovascular disease, unstable pulmonary disease, chronic hepatitis, or AIDS); current or history of an ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye (eg, amblyopia, uncontrolled glaucoma with an IOP > 30mm Hg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis); clinical signs of myopic retinopathy, or a refraction of >-8 diopter power in current prescription; aphakic or pseudophakic patients may be enrolled if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the patient's cataract surgery of either myopic retinopathy or a refraction of >-8 D; intraocular surgery in study eye (eye to be treated) within 60 days prior to enrollment; presence of a scleral buckle in the study eye
Information: paul.sternberg@vanderbilt.edu

► Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Related Macular Degeneration
Sponsor: National Eye Institute (NEI)
Status: Currently enrolling
Purpose: To use an eye imaging test called high speed indocyanine green angiography (HS-ICG), which examines leaky vessels in the eye, to try to find out why individuals respond differently to ranibizumab (Lucentis) treatment for wet age-related macular degeneration (AMD)
Design: Prospective
Number of Patients: 50
Inclusion Criteria: Must be 50 years old or older; must be diagnosed with AMD in at least one eye defined by the presence of drusen at least 63 μm in size; must have CNV secondary to AMD as determined by the investigator; must have VA of better than 20/400 in the affected eye as measured on an ETDRS chart
Exclusion Criteria: CNV, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; geographic atrophy or fibrosis under the fovea; decreased vision due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis, or epiretinal membrane; additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant DME, severe nonproliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; a tear of the RPE; a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy; history of treatment for CNV in the study eye with verteporfin/photodynamic therapy, transpupillary thermotherapy, external beam radiation therapy, or other local treatment (such as submacular surgery); previous subfoveal focal laser photocoagulation (juxtafoveal or extrafoveal) in the study eye; previous ranibizumab, bevacizumab or pegaptanib sodium treatments in the study or fellow eye less than 4 weeks prior to enrollment; prior verteporfin/photodynamic therapy in the fellow eye less than 1 week prior to enrollment; prior intravitreal or peribulbar corticosteroids in the study or fellow eye less than 12 weeks prior to enrollment; evidence of ocular toxoplasmosis; external ocular infection, including conjunctivitis; chalazion; significant blepharitis; or aphakia in the study eye; history of systemic anti-VEGF therapy less than 4 weeks prior to enrollment or will be starting systemic anti-VEGF therapy while on the protocol; intraocular surgery (including lens replacement surgery) within 6 weeks prior to enrollment; history of (within the last 6 months), or current ocular or periocular infection (including any history of ocular herpes zoster or simplex); prior vitrectomy; history of systemic or topical steroid use at any time during the 30 days prior to enrollment; has participated in any other clinical study or is receiving, or has received any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment; has had insertion of a scleral buckle in the study eye; clinical evidence of scleral thinning (defined as an area of blue/grey discoloration of the sclera representing visualization of underlying choroidal tissue through a thinned area of sclera) seen at the time of external eye examination; exhibits clinical signs of myopic retinopathy, or has a refraction of greater than spherical equivalent -8.00D in their current prescription. Pseudophakic participants may be enrolled in this study if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the participant"s cataract surgery of either myopic retinopathy or a refraction of greater than spherical equivalent -8.00D.
Information: prpl@mail.cc.nih.gov

SCREENING
► Study: Evaluation and Treatment of Patients with Retinal Disease Sponsor: National Eye Institute Status: Enrolling patients Purpose: To allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area Design: Natural history Number of Patients: 500 Inclusion Criteria: Diagnosis of AMD Exclusion Criteria: Inability to be followed for 3 years Contact: (800) 411-1222 ► Study: Screening for Studies on Retinovascular Diseases Sponsor: National Eye Institute Status: Enrolling patients Purpose: To help recruit patients for NEI studies of the retina Design: Natural History Number of Patients: 1500 Inclusion and Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study; all studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women Contact: (800) 411-1222 ► Study: Genetic Factors in AMD Sponsor: National Eye Institute Status: Enrolling patients Purpose: To examine whether certain poly morphisms predispose people to develop AMD Design: Screening Number of Patients: 400 Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD defined by geographic atrophy and/or CNV with drusen of any size in at least 1 eye; (Control patients) Age >70 years; absence of drusen or no more than 5 drusen <63 μm; absence of other diagnostic criteria for AMD Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases that have been present prior to the age of 50; opacities of the ocular media; limitations of pupillary dilation or other problems sufficient to preclude adequate stereo fundus photography (occluded pupils due to synechia, cataracts, vitreous haze, and opacities due to ocular diseases) Information: (800) 411-1222 ► Study: Investigating Age-Related Macular Degeneration Sponsor: National Eye Institute Status: Enrolling patients Purpose: To examine an Amish community to investigate genetic factors in the development of AMD Design: Natural History Number of Patients: 1000 Inclusion Criteria: All Amish individuals, ≥50 years Information: (301) 496-6583 ► Study: Ultrasonic Evaluation of Ocular Tissues Sponsor: Weill Medical College of Cornell University/Riverside Research Institute Status: Currently enrolling Purpose: To improve diagnosis and treat ment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques Design: Screening, Cross-sectional, Defined-population, Retrospective/Prospective Study Number of Patients: 150 Inclusion Criteria: Have 1 of the following eye diseases: glaucoma, ocular tumors, AMD Information: (212) 746-6106 ► Study: Screening for Studies on Inherited Eye Diseases Sponsor: National Eye Institute Status: Currently enrolling Purpose: To help recruit patients for NEI studies on inherited eye diseases Design: Natural History Number of Patients: 800 Inclusion/Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis, may be eligible for inclusion in this study Information: (800) 411-1222

SCREENING

► Study: Evaluation and Treatment of Patients with Retinal Disease
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area
Design: Natural history
Number of Patients: 500
Inclusion Criteria: Diagnosis of AMD
Exclusion Criteria: Inability to be followed for 3 years
Contact: (800) 411-1222

► Study: Screening for Studies on Retinovascular Diseases
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To help recruit patients for NEI studies of the retina
Design: Natural History
Number of Patients: 1500
Inclusion and Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unknown conditions that require the establishment of a diagnosis may be eligible for inclusion in this study; all studies of retinovascular diseases require the subject to have minimum age of 18 years in both men and women
Contact: (800) 411-1222

► Study: Genetic Factors in AMD
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine whether certain poly morphisms predispose people to develop AMD
Design: Screening
Number of Patients: 400
Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD defined by geographic atrophy and/or CNV with drusen of any size in at least 1 eye; (Control patients) Age >70 years; absence of drusen or no more than 5 drusen <63 μm; absence of other diagnostic criteria for AMD
Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss such as high myopia, retinal dystrophies, central serous retinopathy, vein occlusion, diabetic retinopathy and uveitis or similar outer retinal diseases that have been present prior to the age of 50; opacities of the ocular media; limitations of pupillary dilation or other problems sufficient to preclude adequate stereo fundus photography (occluded pupils due to synechia, cataracts, vitreous haze, and opacities due to ocular diseases)
Information: (800) 411-1222

► Study: Investigating Age-Related Macular Degeneration
Sponsor: National Eye Institute
Status: Enrolling patients
Purpose: To examine an Amish community to investigate genetic factors in the development of AMD
Design: Natural History
Number of Patients: 1000
Inclusion Criteria: All Amish individuals, ≥50 years
Information: (301) 496-6583

► Study: Ultrasonic Evaluation of Ocular Tissues
Sponsor: Weill Medical College of Cornell University/Riverside Research Institute
Status: Currently enrolling
Purpose: To improve diagnosis and treat ment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques
Design: Screening, Cross-sectional, Defined-population, Retrospective/Prospective Study
Number of Patients: 150
Inclusion Criteria: Have 1 of the following eye diseases: glaucoma, ocular tumors, AMD
Information: (212) 746-6106

► Study: Screening for Studies on Inherited Eye Diseases
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To help recruit patients for NEI studies on inherited eye diseases
Design: Natural History
Number of Patients: 800
Inclusion/Exclusion Criteria: Inclusion and exclusion criteria vary with the particular protocol for which a patient is being screened. In addition to those diagnoses currently under study, subjects with unusual, interesting, or unknown conditions that require the establishment of a diagnosis, may be eligible for inclusion in this study
Information: (800) 411-1222

RETINAL IMAGING STUDIES
► Study: Retinal Imaging in Patients With Inherited Retinal Degenerations Sponsor: University of California-San Francisco/University of California-Berkeley Status: Enrolling patients Purpose: To determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope Design: Natural History, Longitudinal, Defined Population, Prospective Study Number of Patients: 130 Inclusion Criteria: Subjects must have pupils that dilate to at least 6 mm diameter and must be willing to travel to UC Berkeley Exclusion Criteria: Cataract; irregular corneal astigmatism (keratoconus); prior refractive surgery Information: Jacque L. Duncan, MD, (415) 514-4241, duncanj@vision.ucsf.edu ► Study: Novel Diagnostics for Ocular Structure Sponsor: University of Pittsburgh/National Institutes of Health Status: Enrolling patients Purpose: To evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called OCT Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study Number of Patients: 500 Inclusion Criteria: Diagnosis of macular degeneration, diabetic retinopathy, and/or glaucoma Exclusion Criteria: Media opacity (lens, vitreous, cornea); diagnosis of strabismus, nystagmus, or a condition that would prevent fixation Information: Tammy J Capozzoli, (412) 647-2375, capozzolitj@upmc.edu ► Study: Novel Diagnostics With Optical Coherence Tomography: Retinal Imaging Sponsor: University of Pittsburgh Status: Currently enrolling Purpose: To evaluate OCT, an FDA-approved device used to image diseases of the eye Design: Screening, Longitudinal, Convenience Sample, Retrospective/Prospective Study Number of Patients: 1500 Inclusion Criteria: Subjects with healthy eyes, macular degeneration, glaucoma and various other eye diseases. Also must be able to fixate on target. Exclusion Criteria: Fundus not visible or opaque media Information: (412) 647-2375

RETINAL IMAGING STUDIES

► Study: Retinal Imaging in Patients With Inherited Retinal Degenerations
Sponsor: University of California-San Francisco/University of California-Berkeley
Status: Enrolling patients
Purpose: To determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope
Design: Natural History, Longitudinal, Defined Population, Prospective Study
Number of Patients: 130
Inclusion Criteria: Subjects must have pupils that dilate to at least 6 mm diameter and must be willing to travel to UC Berkeley
Exclusion Criteria: Cataract; irregular corneal astigmatism (keratoconus); prior refractive surgery
Information: Jacque L. Duncan, MD, (415) 514-4241, duncanj@vision.ucsf.edu

► Study: Novel Diagnostics for Ocular Structure
Sponsor: University of Pittsburgh/National Institutes of Health
Status: Enrolling patients
Purpose: To evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called OCT
Design: Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Number of Patients: 500
Inclusion Criteria: Diagnosis of macular degeneration, diabetic retinopathy, and/or glaucoma
Exclusion Criteria: Media opacity (lens, vitreous, cornea); diagnosis of strabismus, nystagmus, or a condition that would prevent fixation
Information: Tammy J Capozzoli, (412) 647-2375, capozzolitj@upmc.edu

► Study: Novel Diagnostics With Optical Coherence Tomography: Retinal Imaging
Sponsor: University of Pittsburgh
Status: Currently enrolling
Purpose: To evaluate OCT, an FDA-approved device used to image diseases of the eye
Design: Screening, Longitudinal, Convenience Sample, Retrospective/Prospective Study
Number of Patients: 1500
Inclusion Criteria: Subjects with healthy eyes, macular degeneration, glaucoma and various other eye diseases. Also must be able to fixate on target.
Exclusion Criteria: Fundus not visible or opaque media
Information: (412) 647-2375

DIABETIC MACULAR EDEMA
► Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema Sponsor: Allergan Status: Enrolling patients Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of DME Design: Treatment, Randomized, Doubleblind, Dose-comparison, Parallel Assignment, Safety/Efficacy Study Number of Patients: 860 Inclusion Criteria: Diagnosis of DME; decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse), other eye no worse than 20/200 Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparin Information: clinicaltrials@allergan.com ► Study: Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema (LRT for DME) Sponsor: NEI/Genentech/Allergan Status: Currently enrolling Purpose: To find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone Design: Treatment, Randomized, Singleblind, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 701 Inclusion Criteria: Age ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2) Exclusion Criteria: Significant renal disease; participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry; known allergy to any component of the study drug; blood pressure >180/110 (systolic above 180 OR diastolic above 110); myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization; systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization; pregnancy Information: (866) 372-7601 ×218 ► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy Sponsor: Diabetic Retinopathy Clinical Research Network Status: Currently enrolling Purpose: To determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the risk of VA impairment that can occur following PRP and increase the chances of at least shortterm VA improvement in eyes with evidence of center-involved macular edema that are undergoing PRP for PDR Design: Prospective, Multicenter Randomized Clinical Trial Number of Patients: 380 Inclusion Criteria: Age ≥18 years; type 1 or type 2 diabetes; study eye with proliferative diabetic retinopathy for which the investigator intends to perform fullscatter photocoagulation; DME involving the center of the macula (OCT central subfield thickness >250 μm) and reducing VA to 20/32 or worse Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpd r/ProtJInfo.html ► Study: Effect of Ruboxistaurin on Clinically Significant Macular Edema Sponsor: Eli Lilly and Company Status: Currently enrolling Purpose: To test the hypothesis that oral administration of ruboxistaurin for approximately 18 months will reduce the baseline to endpoint changes in macular thickness, as measured by OCT, in patients with clinically significant macular edema Design: Treatment, Randomized, Doubleblind, Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 220 Inclusion Criteria: Type 1 or 2 diabetes; ≥18 years old; HbA1c less than or equal to 11%; mild to very severe nonproliferative diabetic retinopathy in the study eye; clinically significant macular edema in the study eye Exclusion Criteria: Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye; glaucoma in the study eye; unstable cardiovascular disease; major surgery within past 3 months; significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy Information: (877) 285-4559 ► Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy Sponsor: NEI/Genentech/Allergan Status: Currently enrolling Purpose: To find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment Design: Treatment, Randomized, Singleblind, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 380 Inclusion Criteria: Type 1 or 2 diabetics age ≥18 years Exclusion Criteria: Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization; macular edema is considered to be due to a cause other than DME; ocular condition is present such that, in the opinion of the investigator, preventing VA loss would not improve from resolution of macular edema; substantial cataract that, in the opinion of the investigator, is likely to be decreasing VA by 3 lines or more (ie, cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal); history of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment) Information: (866) 372-7601 ► Study: RISE: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus Sponsor: Genentech Status: Currently enrolling Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2) Design: Treatment Number of Patients: 366 Inclusion Criteria: Retinal thickening secondary to diabetes mellitus involving the center of the fovea with central macular thickness >275 μm in the center subfield, as assessed on OCT and confirmed by the central reading center at screening and by the evaluating physician on day 0; known duration of DME of ≥2 years; BCVA score in the study eye of 20/40 to 20/320 approximate Snellen equivalent using the ETDRS protocol at an initial testing distance of 4 meters, confirmed by the investigator; decrease in vision determined to be the result of DME and not due to other causes Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of study entry; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of study entry; previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of study entry; PDR in the study eye, with the exception of inactive, fibrotic PDR that has regressed following panretinal laser photocoagulation; iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye Information: lane.hayley@gene.com ► Study: A Study of the Safety and Efficacy of a New Treatment in Combination With Laser for Macular Edema Resulting From Diabetic Macular Edema Sponsor: Allergan Status: Enrolling patients Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs laser treatment alone in patients with DME Design: Treatment, Randomized, Singleblind, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 250 Inclusion Criteria: Decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse) and VA in other eye no worse than 20/200 Exclusion Criteria: History of glaucoma or current high IOP requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids; use of warfarin/heparin Information: clinicaltrials@allergan.com ► Study: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin for Treatment of Patients With DME Sponsor: ThromboGenics Status: Currently enrolling Purpose: To compare multiple doses of intravitreal microplasmin for nonsurgical PVD induction for treatment of patients with DME Design: Treatment, Randomized, Doubleblind, Dose-comparison, Single Group Assignment, Safety/Efficacy Study Number of Patients: 60 Inclusion Criteria: >18 years old with DME Exclusion Criteria: PVD present at baseline; vitreous hemorrhage; certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR); patients who have had a vitrectomy in the study eye at any time Information: (212) 201-0920 ×277 ► Study: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus (RIDE) Sponsor: Genentech Status: Currently enrolling Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (type 1 or 2) Design: Treatment Number of Patients: 366 Inclusion Criteria: Age ≥18 years; diabetes mellitus (Type 1 or 2); retinal thickening secondary to diabetes mellitus (DME); BCVA score in the study eye of 20/40 to 20/320; decrease in vision determined to be primarily the result of DME and not to other causes Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of screening; previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of the day 0 visit; PDR in the study eye, with the exception of inactive, regressed PDR; iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye; vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision; ocular inflammation (including trace or above) in the study eye; history of idiopathic or autoimmune uveitis in either eye; structural damage to the center of the macula in the study eye that is likely to preclude improvement in VA following the resolution of macular edema; ocular disorders in the study eye that may confound interpretation of study results; concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period Information: (888) 662-6728 ► Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema Sponsor: Rocky Mountain Retina Consultants/Genentech Status: Currently enrolling Purpose: To evaluate the clinical efficacy of intravitreal injections of ranibizumab (Lucentis) in the treatment of diabetic macular edema as compared to grid/focal laser Design: Treatment, Randomized, Openlabel, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 60 Inclusion Criteria: Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991) Retinal thickening within 500 μm of the center of the fovea; hard exudates within 500 μm of the center of the fovea (if associated with adjacent retinal thickening, which may be outside of 500 μm limit); area of macular edema greater than 1 disc area but within 1 disc diameter of the center of the macula; age >21 years; VA <20/320 with definite retinal thickening due to diabetic macular edema based on clinical exam; retinal thickness on OCT measuring 250 μm or more in the central subfield or 350 μm of more in any noncentral subfield. Media clarity and pupillary dilation, patient cooperation, and adequate fundus photographs and OCT will be obtainable; no other ocular conditions that could cause macular edema will be present Exclusion Criteria: Intraocular pressures exceed 25 mm Hg; participation in another simultaneous medical investigation or trial or previous trial of Lucentis or Avastin; premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch; current treatment of a systemic infection; evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; history of recurrent significant infections or bacterial infections; any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye; history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye; history of idiopathic or autoimmune-associated uveitis in either eye; active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye; concurrent ocular disease associated with choroidal neovascularization to include but not limited to presumed ocular histoplasmosis, high myopia, or macular degeneration Information: study@rmrc.xohost.com ► Study: Combined Approach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study Sponsor: Johns Hopkins University/Juvenile Diabetes Research Foundation/Genentech Status: Currently enrolling Purpose: To continue the study of anti-VEGF therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined anti-VEGF and anti-inflammatory Design: Treatment, Randomized, Openlabel, Dose-comparison, Factorial Assignment, Safety/Efficacy Study Number of Patients: 72 Inclusion Criteria: 18 years of age; diagnosis of diabetes mellitus (type 1 or type 2); serum HbA1c 5.5% within 12 months of randomization; retinal thickening (diabetic macular edema) involving the center of the fovea; diagnosis must be confirmed by FA and OCT images over 250; BCVA score in the study eye of 20/40 to 20/320 Exclusion Criteria: Panretinal or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry; previous participation in a study and receipt of antiangiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry; current or history of prior treatment of psoriasis with subcutaneous efalizumab within 6 months of study entry; proliferative diabetic retinopathy in the study eye Information: jdenton2@jhmi.edu ► Study: Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy Sponsor: Novagali Pharma Status: Currently enrolling Purpose: To evaluate the safety and efficacy of a single injection of NOVA63035 "Corticosteroid" administered at 1 of 3 doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy Design: Supportive Care, Non-randomized, Open-label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 18 Inclusion Criteria: At least 18 years old; diagnosed with diabetes mellitus and presenting diabetic retinopathy Exclusion Criteria: Monocularity; history of current ocular hypertension or glaucoma in either eye defined; any significant ocular disease (other than diabetic retinopathy) Information: mourad.amrane@novagali.com ► Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II) Sponsor: Genentech/Michael J. Jumper, MD Status: Currently enrolling Purpose: To study the safety and efficacy of a single dose of intravitreally administered ranibizumab 0.5 mg in subjects with proliferative diabetic retinopathy experiencing post-panretinal photocoagulation (PRP) macular edema Design: Treatment, Randomized, Openlabel, Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Pre-PRP protocol refraction, fluorescein angiography, and OCT AND 7-14 day post-PRP OCT; previously untreated PDR patients with high-risk characteristics who develop edema within 7-14 days post-PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (>20% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>20% increase from pre-PRP macular volume) Exclusion Criteria: Participation in another simultaneous medical investigation or trial; pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP; neovascularization of the iris or neovascular glaucoma; increased central foveal thickness for any other reason; concurrent macular diseases that could confound the results of this study; prior vitrectomy in the study eye; prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide Information: jrose@westcoastretina.com

DIABETIC MACULAR EDEMA

► Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Sponsor: Allergan
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of DME
Design: Treatment, Randomized, Doubleblind, Dose-comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 860
Inclusion Criteria: Diagnosis of DME; decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse), other eye no worse than 20/200
Exclusion Criteria: Known anticipated need for ocular surgery within next 12 months; history of glaucoma or current high eye pressure requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids or warfarin/heparin
Information: clinicaltrials@allergan.com

► Study: Laser-Ranibizumab-Triamcinolone for Diabetic Macular Edema (LRT for DME)
Sponsor: NEI/Genentech/Allergan
Status: Currently enrolling
Purpose: To find out which is a better treatment for DME: laser alone, laser combined with an intravitreal injection of triamcinolone, laser combined with an intravitreal injection of ranibizumab, or intravitreal injection of ranibizumab alone
Design: Treatment, Randomized, Singleblind, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 701
Inclusion Criteria: Age ≥18 years; diagnosis of diabetes mellitus (type 1 or type 2)
Exclusion Criteria: Significant renal disease; participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry; known allergy to any component of the study drug; blood pressure >180/110 (systolic above 180 OR diastolic above 110); myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization; systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization; pregnancy
Information: (866) 372-7601 ×218

► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Sponsor: Diabetic Retinopathy Clinical Research Network
Status: Currently enrolling
Purpose: To determine whether intravitreal injection of an anti-VEGF drug or an intravitreal injection of a corticosteroid can reduce the risk of VA impairment that can occur following PRP and increase the chances of at least shortterm VA improvement in eyes with evidence of center-involved macular edema that are undergoing PRP for PDR
Design: Prospective, Multicenter Randomized Clinical Trial
Number of Patients: 380
Inclusion Criteria: Age ≥18 years; type 1 or type 2 diabetes; study eye with proliferative diabetic retinopathy for which the investigator intends to perform fullscatter photocoagulation; DME involving the center of the macula (OCT central subfield thickness >250 μm) and reducing VA to 20/32 or worse
Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpd r/ProtJInfo.html

► Study: Effect of Ruboxistaurin on Clinically Significant Macular Edema
Sponsor: Eli Lilly and Company
Status: Currently enrolling
Purpose: To test the hypothesis that oral administration of ruboxistaurin for approximately 18 months will reduce the baseline to endpoint changes in macular thickness, as measured by OCT, in patients with clinically significant macular edema
Design: Treatment, Randomized, Doubleblind, Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 220
Inclusion Criteria: Type 1 or 2 diabetes; ≥18 years old; HbA1c less than or equal to 11%; mild to very severe nonproliferative diabetic retinopathy in the study eye; clinically significant macular edema in the study eye
Exclusion Criteria: Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye; glaucoma in the study eye; unstable cardiovascular disease; major surgery within past 3 months; significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy
Information: (877) 285-4559

► Study: Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy
Sponsor: NEI/Genentech/Allergan
Status: Currently enrolling
Purpose: To find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment
Design: Treatment, Randomized, Singleblind, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 380
Inclusion Criteria: Type 1 or 2 diabetics age ≥18 years
Exclusion Criteria: Prior panretinal photocoagulation that was sufficiently extensive that the investigator does not believe that at least 1200 additional burns are needed or possible within 49 days after randomization; macular edema is considered to be due to a cause other than DME; ocular condition is present such that, in the opinion of the investigator, preventing VA loss would not improve from resolution of macular edema; substantial cataract that, in the opinion of the investigator, is likely to be decreasing VA by 3 lines or more (ie, cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal); history of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment)
Information: (866) 372-7601

► Study: RISE: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (Type 1 or 2)
Design: Treatment
Number of Patients: 366
Inclusion Criteria: Retinal thickening secondary to diabetes mellitus involving the center of the fovea with central macular thickness >275 μm in the center subfield, as assessed on OCT and confirmed by the central reading center at screening and by the evaluating physician on day 0; known duration of DME of ≥2 years; BCVA score in the study eye of 20/40 to 20/320 approximate Snellen equivalent using the ETDRS protocol at an initial testing distance of 4 meters, confirmed by the investigator; decrease in vision determined to be the result of DME and not due to other causes
Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of study entry; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of study entry; previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of study entry; PDR in the study eye, with the exception of inactive, fibrotic PDR that has regressed following panretinal laser photocoagulation; iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye
Information: lane.hayley@gene.com

► Study: A Study of the Safety and Efficacy of a New Treatment in Combination With Laser for Macular Edema Resulting From Diabetic Macular Edema
Sponsor: Allergan
Status: Enrolling patients
Purpose: To evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs laser treatment alone in patients with DME
Design: Treatment, Randomized, Singleblind, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 250
Inclusion Criteria: Decrease in VA in at least 1 eye as a result of macular edema (20/50 or worse) and VA in other eye no worse than 20/200
Exclusion Criteria: History of glaucoma or current high IOP requiring more than 1 medication; uncontrolled systemic disease; known steroid-responder; use of systemic steroids; use of warfarin/heparin
Information: clinicaltrials@allergan.com

► Study: A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin for Treatment of Patients With DME
Sponsor: ThromboGenics
Status: Currently enrolling
Purpose: To compare multiple doses of intravitreal microplasmin for nonsurgical PVD induction for treatment of patients with DME
Design: Treatment, Randomized, Doubleblind, Dose-comparison, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 60
Inclusion Criteria: >18 years old with DME
Exclusion Criteria: PVD present at baseline; vitreous hemorrhage; certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR); patients who have had a vitrectomy in the study eye at any time
Information: (212) 201-0920 ×277

► Study: A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema With Center Involvement Secondary to Diabetes Mellitus (RIDE)
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of ranibizumab injection in patients with CSME-CI secondary to diabetes mellitus (type 1 or 2)
Design: Treatment
Number of Patients: 366
Inclusion Criteria: Age ≥18 years; diabetes mellitus (Type 1 or 2); retinal thickening secondary to diabetes mellitus (DME); BCVA score in the study eye of 20/40 to 20/320; decrease in vision determined to be primarily the result of DME and not to other causes
Exclusion Criteria: History of vitreoretinal surgery in the study eye; panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening; previous use of intraocular corticosteroids in the study eye (eg, TA) within 3 months of screening; previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) within 3 months of the day 0 visit; PDR in the study eye, with the exception of inactive, regressed PDR; iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in the study eye; vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or on OCT that is considered by the investigator to significantly affect central vision; ocular inflammation (including trace or above) in the study eye; history of idiopathic or autoimmune uveitis in either eye; structural damage to the center of the macula in the study eye that is likely to preclude improvement in VA following the resolution of macular edema; ocular disorders in the study eye that may confound interpretation of study results; concurrent disease in the study eye that would compromise VA or require medical or surgical intervention during the study period
Information: (888) 662-6728

► Study: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
Sponsor: Rocky Mountain Retina Consultants/Genentech
Status: Currently enrolling
Purpose: To evaluate the clinical efficacy of intravitreal injections of ranibizumab (Lucentis) in the treatment of diabetic macular edema as compared to grid/focal laser
Design: Treatment, Randomized, Openlabel, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 60
Inclusion Criteria: Clinically significant diabetic macular edema (CSME) or clinically significant diabetic macular edema with center involvement (CSME-CI) as defined by the ETDRS Trial (ETDRS Research Group 1987 and 1991) Retinal thickening within 500 μm of the center of the fovea; hard exudates within 500 μm of the center of the fovea (if associated with adjacent retinal thickening, which may be outside of 500 μm limit); area of macular edema greater than 1 disc area but within 1 disc diameter of the center of the macula; age >21 years; VA <20/320 with definite retinal thickening due to diabetic macular edema based on clinical exam; retinal thickness on OCT measuring 250 μm or more in the central subfield or 350 μm of more in any noncentral subfield. Media clarity and pupillary dilation, patient cooperation, and adequate fundus photographs and OCT will be obtainable; no other ocular conditions that could cause macular edema will be present
Exclusion Criteria: Intraocular pressures exceed 25 mm Hg; participation in another simultaneous medical investigation or trial or previous trial of Lucentis or Avastin; premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization, use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch; current treatment of a systemic infection; evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders; history of recurrent significant infections or bacterial infections; any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could either require medical or surgical intervention during the 12-month study period to prevent or treat visual loss that might result from that condition, or if allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of BCVA over the 12-month study period Active intraocular inflammation (grade trace or above) in the study eye Current vitreous hemorrhage in the study eye; history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye; history of idiopathic or autoimmune-associated uveitis in either eye; active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye; concurrent ocular disease associated with choroidal neovascularization to include but not limited to presumed ocular histoplasmosis, high myopia, or macular degeneration
Information: study@rmrc.xohost.com

► Study: Combined Approach to Treatment Using Ranibizumab and Efalizumab for Diabetic Macular Edema Study: The CAPTURE DME Study
Sponsor: Johns Hopkins University/Juvenile Diabetes Research Foundation/Genentech
Status: Currently enrolling
Purpose: To continue the study of anti-VEGF therapy in patients with macular edema, and compare it to an anti-inflammatory therapy and a combined anti-VEGF and anti-inflammatory
Design: Treatment, Randomized, Openlabel, Dose-comparison, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 72
Inclusion Criteria: 18 years of age; diagnosis of diabetes mellitus (type 1 or type 2); serum HbA1c 5.5% within 12 months of randomization; retinal thickening (diabetic macular edema) involving the center of the fovea; diagnosis must be confirmed by FA and OCT images over 250; BCVA score in the study eye of 20/40 to 20/320
Exclusion Criteria: Panretinal or macular photocoagulation within 3 months of study entry in the study eye; use of intraocular or periocular injection of steroids in the study eye within 3 months of study entry; previous participation in a study and receipt of antiangiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry; current or history of prior treatment of psoriasis with subcutaneous efalizumab within 6 months of study entry; proliferative diabetic retinopathy in the study eye
Information: jdenton2@jhmi.edu

► Study: Safety and Tolerability of NOVA63035 "Corticosteroid" in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy
Sponsor: Novagali Pharma
Status: Currently enrolling
Purpose: To evaluate the safety and efficacy of a single injection of NOVA63035 "Corticosteroid" administered at 1 of 3 doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy
Design: Supportive Care, Non-randomized, Open-label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 18
Inclusion Criteria: At least 18 years old; diagnosed with diabetes mellitus and presenting diabetic retinopathy
Exclusion Criteria: Monocularity; history of current ocular hypertension or glaucoma in either eye defined; any significant ocular disease (other than diabetic retinopathy)
Information: mourad.amrane@novagali.com

► Study: Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)
Sponsor: Genentech/Michael J. Jumper, MD
Status: Currently enrolling
Purpose: To study the safety and efficacy of a single dose of intravitreally administered ranibizumab 0.5 mg in subjects with proliferative diabetic retinopathy experiencing post-panretinal photocoagulation (PRP) macular edema
Design: Treatment, Randomized, Openlabel, Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Pre-PRP protocol refraction, fluorescein angiography, and OCT AND 7-14 day post-PRP OCT; previously untreated PDR patients with high-risk characteristics who develop edema within 7-14 days post-PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (>20% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (>20% increase from pre-PRP macular volume)
Exclusion Criteria: Participation in another simultaneous medical investigation or trial; pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP; neovascularization of the iris or neovascular glaucoma; increased central foveal thickness for any other reason; concurrent macular diseases that could confound the results of this study; prior vitrectomy in the study eye; prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide
Information: jrose@westcoastretina.com

RETINAL VEIN OCCLUSION
► Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion Sponsor: Greater Houston Retina Research Status: Enrolling patients Purpose: To see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic CRVO Design: Treatment, Randomized, Openlabel, Active-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Ischemic CRVO within 3 months of enrollment as per the following Inclusion Criteria: VA 20/200 or worse; RAPD 0.9 LU or worse; loss of 1-2e isopter on Goldmann visual field; ERG demonstrating B-wave amplitude less than 60% of A wave Exclusion Criteria: Angle neovascularization greater than 3 clock hours with IOP over 30 (neovascular glaucoma); any previous retinal laser photocoagulation to the study eye, any previous intravitreal injection in study eye (triamcinolone or other), or any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery); intracapsular cataract extraction (posterior capsule needs to be present); previous history of retinal detachment in study eye; any previous radiation treatments to head/neck; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study or significant diabetic retinopathy in the fellow eye (DME, proliferative diabetic retinopathy, or high-risk nonproliferative diabetic retinopathy); pregnancy Information: (713) 524-3434 ► Study: CRUISE: A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion Sponsor: Genentech Status: Currently enrolling Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVO Study Design: Treatment Number of Patients: 390 Inclusion Criteria: Foveal centerinvolved macular edema secondary to CRVO; BCVA using ETDRS charts of 20/50 to 20/320 (Snellen equivalent) in the study eye; mean central subfield thickness ≥250 μm on 2 OCT measurements; media clarity, pupillary dilation, and participant cooperation sufficient for adequate fundus photographs Exclusion Criteria: History of cerebral vascular accident or myocardial infarction within 3 months prior to day 0; history of any anti-VEGF treatment in fellow eye within 3 months prior to day 0; history of allergy to fluorescein not amenable to treatment; history of allergy to ranibizumab injection or related molecule; relevant systemic disease that may be associated with increased systemic VEGF levels Information: (888) 662-6728 ► Study: BRAVO: Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion Sponsor: Genentech Status: Currently enrolling Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to BRVO Study Design: Treatment Number of Patients: 390 Inclusion Criteria: Foveal centerinvolved macular edema secondary to BRVO; BCVA using ETDRS charts of 20/50 to 20/320 (Snellen equivalent) in the study eye; mean central subfield thickness ≥250 μm on 2 OCT measurements; media clarity, pupillary dilation, and participant cooperation sufficient for adequate fundus photographs Exclusion Criteria: History of cerebral vascular accident or myocardial infarction within 3 months prior to day 0; history of any anti-VEGF treatment in fellow eye within 3 months prior to day 0; history of allergy to fluorescein not amenable to treatment; history of allergy to ranibizumab injection or related molecule; relevant systemic disease that may be associated with increased systemic VEGF levels Information: (888) 662-6728 ► Study: Effectiveness and Safety of Niacin and a Topical Steroid to Treat Retinal Vein Occlusions Sponsor: Palo Alto Medical Foundation Status: Currently enrolling Purpose: To determine whether niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye Design: Treatment, Non-randomized, Open-label, Active-control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 68 Inclusion Criteria: Patient must have central retinal vein occlusion, hemiretinal vein occlusion or branch retinal vein occlusion Exclusion Criteria: Active gout or high levels of uric acid Information: gaynonM@pamf.org ► Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion Sponsor: Palmetto Retina Center, LLC; Pfizer; Eyetech Pharmaceuticals Status: Currently enrolling Purpose: Study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO) Design: Treatment, Randomized, Openlabel, Uncontrolled, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age; duration of BRVO macular edema less than 6 months prior to baseline visit; best corrected ETDRS VA 20/40 to 20/320 (Snellen equivalent) using the 4 meters testing method; central foveal thickness greater than or equal to 250 μm using the OCT-3; <25% of foveal capillary ring disruption; <2 disc areas of capillary nonperfusion within 1000 μm of the foveal center; absence of hemorrhage or lipid in the foveal center Exclusion Criteria: Ocular conditions other than BRVO-related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor; intraocular surgery within past 3 months; significant enlargement of foveal avascular zone(>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 μm of foveal center; likelihood of evidence-driven indication for peripheral photocoagulation in the next 6 months; patients who have shown evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of >15 letters of vision or thinning of the Center Point on OCT of >20% from baseline determination; prior grid laser within 4 months of baseline or more than 1 prior grid laser treatment; no prior intravitreous or periocular steroid injections in the study eye Information: jackwells@palmettoretina.com ► Study: Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO) Sponsor: Duke University; Bausch & Lomb Status: Currently enrolling Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity Design: Treatment, Non-randomized, Open-label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: A history of retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and OCT; macular edema at least 1 disc area in size that involved the fovea; males and nonpregnant females at least 18 years of age; IOP controlled at <21 mm Hg with no more than one topical ocular antihypertensive agent; initially, patients with vein occlusion were not required to have previous therapy. However, the protocol was subsequently modified to require an intravitreal injection of triamcinolone acetonide >12 weeks prior to study entry, with an initial decrease in macular edema and improvement in VA and subsequent decline in VA accompanied by increased macular edema. This modification was added to avoid enrolling patients who might have had a longlasting response to a single intravitreal triamcinolone acetonide injection. Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status; patients with disciform scars of the fovea or atrophic changes of the macula that in the investigator"s opinion would preclude benefit from treatment are excluded from the study; female patients who were pregnant or lactating or not taking precautions to avoid pregnancy Information: (919) 684-4458

RETINAL VEIN OCCLUSION

► Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion
Sponsor: Greater Houston Retina Research
Status: Enrolling patients
Purpose: To see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic CRVO
Design: Treatment, Randomized, Openlabel, Active-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Ischemic CRVO within 3 months of enrollment as per the following Inclusion Criteria: VA 20/200 or worse; RAPD 0.9 LU or worse; loss of 1-2e isopter on Goldmann visual field; ERG demonstrating B-wave amplitude less than 60% of A wave
Exclusion Criteria: Angle neovascularization greater than 3 clock hours with IOP over 30 (neovascular glaucoma); any previous retinal laser photocoagulation to the study eye, any previous intravitreal injection in study eye (triamcinolone or other), or any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery); intracapsular cataract extraction (posterior capsule needs to be present); previous history of retinal detachment in study eye; any previous radiation treatments to head/neck; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study or significant diabetic retinopathy in the fellow eye (DME, proliferative diabetic retinopathy, or high-risk nonproliferative diabetic retinopathy); pregnancy
Information: (713) 524-3434

► Study: CRUISE: A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVO
Study Design: Treatment
Number of Patients: 390
Inclusion Criteria: Foveal centerinvolved macular edema secondary to CRVO; BCVA using ETDRS charts of 20/50 to 20/320 (Snellen equivalent) in the study eye; mean central subfield thickness ≥250 μm on 2 OCT measurements; media clarity, pupillary dilation, and participant cooperation sufficient for adequate fundus photographs
Exclusion Criteria: History of cerebral vascular accident or myocardial infarction within 3 months prior to day 0; history of any anti-VEGF treatment in fellow eye within 3 months prior to day 0; history of allergy to fluorescein not amenable to treatment; history of allergy to ranibizumab injection or related molecule; relevant systemic disease that may be associated with increased systemic VEGF levels
Information: (888) 662-6728

► Study: BRAVO: Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to BRVO
Study Design: Treatment
Number of Patients: 390
Inclusion Criteria: Foveal centerinvolved macular edema secondary to BRVO; BCVA using ETDRS charts of 20/50 to 20/320 (Snellen equivalent) in the study eye; mean central subfield thickness ≥250 μm on 2 OCT measurements; media clarity, pupillary dilation, and participant cooperation sufficient for adequate fundus photographs
Exclusion Criteria: History of cerebral vascular accident or myocardial infarction within 3 months prior to day 0; history of any anti-VEGF treatment in fellow eye within 3 months prior to day 0; history of allergy to fluorescein not amenable to treatment; history of allergy to ranibizumab injection or related molecule; relevant systemic disease that may be associated with increased systemic VEGF levels
Information: (888) 662-6728

► Study: Effectiveness and Safety of Niacin and a Topical Steroid to Treat Retinal Vein Occlusions
Sponsor: Palo Alto Medical Foundation
Status: Currently enrolling
Purpose: To determine whether niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye
Design: Treatment, Non-randomized, Open-label, Active-control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 68
Inclusion Criteria: Patient must have central retinal vein occlusion, hemiretinal vein occlusion or branch retinal vein occlusion
Exclusion Criteria: Active gout or high levels of uric acid
Information: gaynonM@pamf.org

► Study: Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
Sponsor: Palmetto Retina Center, LLC; Pfizer; Eyetech Pharmaceuticals
Status: Currently enrolling
Purpose: Study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO)
Design: Treatment, Randomized, Openlabel, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Macular edema secondary to BRVO involving the foveal center in male or female patients at least 18 years of age; duration of BRVO macular edema less than 6 months prior to baseline visit; best corrected ETDRS VA 20/40 to 20/320 (Snellen equivalent) using the 4 meters testing method; central foveal thickness greater than or equal to 250 μm using the OCT-3; <25% of foveal capillary ring disruption; <2 disc areas of capillary nonperfusion within 1000 μm of the foveal center; absence of hemorrhage or lipid in the foveal center
Exclusion Criteria: Ocular conditions other than BRVO-related macular edema such as significant cataract, diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular traction or tumor; intraocular surgery within past 3 months; significant enlargement of foveal avascular zone(>25% disruption of capillary ring) or greater than 2 disc areas of nonperfusion within 1000 μm of foveal center; likelihood of evidence-driven indication for peripheral photocoagulation in the next 6 months; patients who have shown evidence of spontaneous improvement within the preceding 3 months, as determined by an improvement of >15 letters of vision or thinning of the Center Point on OCT of >20% from baseline determination; prior grid laser within 4 months of baseline or more than 1 prior grid laser treatment; no prior intravitreous or periocular steroid injections in the study eye
Information: jackwells@palmettoretina.com

► Study: Fluocinolone Acetonide Implant for Retinal Vein Occlusion (RVO)
Sponsor: Duke University; Bausch & Lomb
Status: Currently enrolling
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity
Design: Treatment, Non-randomized, Open-label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: A history of retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and OCT; macular edema at least 1 disc area in size that involved the fovea; males and nonpregnant females at least 18 years of age; IOP controlled at <21 mm Hg with no more than one topical ocular antihypertensive agent; initially, patients with vein occlusion were not required to have previous therapy. However, the protocol was subsequently modified to require an intravitreal injection of triamcinolone acetonide >12 weeks prior to study entry, with an initial decrease in macular edema and improvement in VA and subsequent decline in VA accompanied by increased macular edema. This modification was added to avoid enrolling patients who might have had a longlasting response to a single intravitreal triamcinolone acetonide injection.
Exclusion Criteria: Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status; patients with disciform scars of the fovea or atrophic changes of the macula that in the investigator"s opinion would preclude benefit from treatment are excluded from the study; female patients who were pregnant or lactating or not taking precautions to avoid pregnancy
Information: (919) 684-4458

UVEITIS
► Study: LUMINATE: A Study of LX211 in Active Sight-Threatening, Noninfectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis Sponsor: Lux Biosciences, Inc. Status: Currently enrolling Purpose: To evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis Design: Treatment, Randomized, Doubleblind, Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 210 Inclusion Criteria: Documented history of noninfectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis; currently uncontrolled uveitis for a minimum of 2 weeks despite prednisone monotherapy at a dose of ≥10 mg/day (or equivalent) or ≥2 injections of corticosteroid (intravitreal or periocular) within the past 6 months or subjects for whom oral corticosteroid is contraindicated; grade of 2+ or higher for vitreous haze at time of enrollment; considered by the investigator to require corticosteroid-sparing therapy; not planning to undergo elective ocular surgery during the study Exclusion Criteria: Uveitis of infectious etiology; clinically suspected or confirmed central nervous system or ocular lymphoma; primary diagnosis of anterior uveitis Information: clinicaltrials@luxbio.com ► Study: MUST: Multicenter Uveitis Steroid Treatment Sponsor: National Eye Institute Status: Currently enrolling Purpose: To compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of noninfectious intermediate uveitis, posterior uveitis, or panuveitis. Design: Treatment, Randomized, Openlabel, Active-control, Parallel Assignment, Efficacy Study Number of Patients: 400 Inclusion Criteria: Age ≥18; BCVA of 20/200 in at least 1 eye with severe uveitis; intraocular pressure 24 mm Hg or less in all eyes with severe uveitis; media clarity sufficient to allow visualization and imaging of the fundus in at least 1 eye with severe uveitis Exclusion Criteria: Inadequately controlled diabetes; uncontrolled glaucoma or glaucoma requiring more than 1 antiglaucoma medication in 1 or more eyes with severe uveitis; advanced glaucomatous optic nerve injury; history of scleritis; presence of an ocular toxoplasmosis scar; HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated Information: (301) 451-2020 ► Study: Immune Responses to Antigens in Noninfectious Eye Inflammatory Diseases Sponsor: National Eye Institute Status: Currently enrolling Purpose: To analyze blood samples or substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments Design: Natural history Number of Patients: 200 Inclusion Criteria: Patients ≥6 years old with a diagnosis of ocular inflammatory disease Information: (800) 411-1222 ► Study: Study of Difluprednate in the Treatment of Uveitis Sponsor: Sirion Therapeutics Status: Currently enrolling Purpose: To determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis Design: Multicenter, Randomized, Double-masked, Parallel-group, Active-controlled Number of Patients: 90 Inclusion Criteria: Age ≥2 years or older; Diagnosis of endogenous anterior uveitis in at least 1 eye Exclusion Criteria: Presence of intermediate uveitis, posterior uveitis, or panuveitis; corneal abrasion or ulceration; any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease; allergy to similar drugs, such as other corticosteroids Contact: (813) 496-7325 ×300 or clinical. trials@siriontherapeutics.com ► Study: Phase 2 Study of MM-093 to Treat Patients With Uveitis Sponsor: Merrimack Pharmaceuticals Status: Currently enrolling Purpose: To evaluate the tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe uveitis Design: Treatment, Randomized, Doubleblind, Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Documented diagnosis of sarcoid or birdshot uveitis for at least 6 months as defined by each of the following: inflammatory cells in the anterior chamber and/or vitreous body ≥2+; and loss of visual function as reflected by a prolongation of 30 Hz scotopic implicit time on ERG testing and/or loss of vision to the 20/40 level or lower on visual acuity testing for patients with birdshot retinochoroidopathy Exclusion Criteria: Significant concurrent medical disease or prior medications or treatments up to 2 months before study begins Information: (617) 441-1000 ► Study: Immune Indicators of Uveitis Sponsor: National Eye Institute Status: Enrolling patients Purpose To identify markers of immune activity in uveitis patients that correlate with the state of disease activity. Design: Observational Number of Patients: 100 Inclusion Criteria: Patients with bilateral sight-threatening uveitis requiring systemic immunotherapy who are 18 years and older are eligible. Disease can be active or quiescent, but subjects must be on a minimum prescribed therapy upon enrollment of a dose averaging at least 20 mg/day (or greater than or equal to 0.25 mg/kg/day) of systemic prednisone or a more intensive immunosuppression regimen. More intensive regimens may include from 1 to 3 antiinflammatory treatments for uveitis that include any 1 of the following (or related) compounds: corticosteroids (including systemic or periorbital administration), topical corticosteroids (when used in combination with other agents), cyclophosphamide, cyclosporine, azathioprine, chlorambucil, tacrolimus, leflunomide, mycophenolate mofetil, or methotrexate; patients who have noninfectious intermediate, posterior, or panuveitis of at least 3 months duration. Included conditions may include but are not limited to intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, birdshot retinochoroidopathy, retinal UVEITIS vasculitis and sympathetic ophthalmia Exclusion Criteria: Pregnancy; having another disease or condition affecting vision that will interfere with obtaining study data Information: prpl@mail.cc.nih.gov ► Study: Quality of Life and Visual Function in Uveitis Patients Sponsor: New York Eye and Ear Infirmary Status: Currently enrolling Purpose: To measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis Design: Screening, Cross-sectional, Defined-population, Prospective Study Number of Patients: 50 Inclusion Criteria: Age >18 years old; diagnosis of uveitis Information: (212) 979-4251 ► Study: Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis Sponsor: Novartis Status: Currently enrolling Purpose: To assess the efficacy of AEB071 300 mg twice daily as a therapy for uveitis, using reduction in swelling of the retina as a primary endpoint Design: Treatment, Randomized, Double-blind (Subject, Investigator), Placebo-control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 40 Inclusion Criteria: Male and female patients with noninfectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health; macular edema with average central retinal thickness >300 μm that was determined to have been present for less than 12 months; vitreous haze score >0.5, but <3 (based on the National Eye Institute grading system); BCVA no worse than 20/400 and no better than 20/40 Exclusion Criteria: Patients with CNV; Patients who had a prior vitrectomy; any eye condition that may affect the evaluation of VA and retinal thickness; concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol); use of systemic medications known to be toxic to the lens, retina, or optic nerve (eg, deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months Information: (862) 778-8300 ► Study: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease Sponsor: National Eye Institute Status: Currently enrolling Purpose: To examine the proteins of people with uveitis, or inflammation of the eyes. Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back of the lens, is now possible with the use of new microtechnology. There is an opportunity to evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening uveitis Design: Observational Number of Patients: 5 Inclusion Criteria: Patients meet the criteria for entry into the MUST study and have been randomized to receive a steroid implant; those who are in other studies must participate in a study that permits the evaluation of specimens Exclusion Criteria: Patients who have met the criteria for participation in the MUST study and do not wish to donate their vitreous specimen or blood sample; those in other studies who wish to participate but do not wish to have their specimens evaluated Information: prpl@mail.cc.nih.gov ► Study: Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Retinal Diseases Sponsor: National Eye Institute Status: Currently enrolling Purpose: To study epigenetic mechanisms, the inheritance of (both Mendelian and complex) and biomarkers of immune-mediated eye diseases, in families of many nationalities and ethnic backgrounds in order to identify the genes that, when mutated or demethylated or aceytylated, cause immune mediated eye disease, and the pathophysiology through which they act Design: Observational Number of Patients: 500 Inclusion Criteria: Individuals or family members of individuals with immunemediated retinal disorders, including uveitis, AMD, and diabetic retinopathy; children must be older than 4 years of age Exclusion Criteria: Individuals with diseases, infections, or trauma that mimic immune medicated retinal disorders Information: prpl@mail.cc.nih.gov ► Study: LIME: Lucentis for Inflammatory Macular Edema Trial Sponsor: University of California, San Francisco/Genentech Status: Currently enrolling Purpose: To determine if ranibizumab, an FDA-approved treatment for neovascular age-related macular degeneration, is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or are non-responsive to steroids Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study Number of Patients: 10 Inclusion Criteria: History of noninfectious uveitis with chronic cystoid macular edema (> 3 months duration); anterior chamber and vitreous inflammation at the trace or below level according to the standardized classification of inflammation; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography Exclusion Criteria: Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study. Study subjects will be allowed to continue their immunomodulatory treatment for uveitis throughout the study; previous vitrectomy; active intraocular inflammation in the study eye (greater than trace anterior chamber or vitreous cells); current vitreous hemorrhage; active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye; intraocular pressure >30 mm Hg despite treatment with glaucoma medications; blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by antihypertensive treatment, the subject can become eligible Information: kevin.hong@ucsf.edu

UVEITIS

► Study: LUMINATE: A Study of LX211 in Active Sight-Threatening, Noninfectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Sponsor: Lux Biosciences, Inc.
Status: Currently enrolling
Purpose: To evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis
Design: Treatment, Randomized, Doubleblind, Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 210
Inclusion Criteria: Documented history of noninfectious intermediate-, anterior and intermediate-, posterior- or panuveitis uveitis; currently uncontrolled uveitis for a minimum of 2 weeks despite prednisone monotherapy at a dose of ≥10 mg/day (or equivalent) or ≥2 injections of corticosteroid (intravitreal or periocular) within the past 6 months or subjects for whom oral corticosteroid is contraindicated; grade of 2+ or higher for vitreous haze at time of enrollment; considered by the investigator to require corticosteroid-sparing therapy; not planning to undergo elective ocular surgery during the study
Exclusion Criteria: Uveitis of infectious etiology; clinically suspected or confirmed central nervous system or ocular lymphoma; primary diagnosis of anterior uveitis
Information: clinicaltrials@luxbio.com

► Study: MUST: Multicenter Uveitis Steroid Treatment
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of noninfectious intermediate uveitis, posterior uveitis, or panuveitis.
Design: Treatment, Randomized, Openlabel, Active-control, Parallel Assignment, Efficacy Study
Number of Patients: 400
Inclusion Criteria: Age ≥18; BCVA of 20/200 in at least 1 eye with severe uveitis; intraocular pressure 24 mm Hg or less in all eyes with severe uveitis; media clarity sufficient to allow visualization and imaging of the fundus in at least 1 eye with severe uveitis
Exclusion Criteria: Inadequately controlled diabetes; uncontrolled glaucoma or glaucoma requiring more than 1 antiglaucoma medication in 1 or more eyes with severe uveitis; advanced glaucomatous optic nerve injury; history of scleritis; presence of an ocular toxoplasmosis scar; HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated
Information: (301) 451-2020

► Study: Immune Responses to Antigens in Noninfectious Eye Inflammatory Diseases
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To analyze blood samples or substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments
Design: Natural history
Number of Patients: 200
Inclusion Criteria: Patients ≥6 years old with a diagnosis of ocular inflammatory disease
Information: (800) 411-1222

► Study: Study of Difluprednate in the Treatment of Uveitis
Sponsor: Sirion Therapeutics
Status: Currently enrolling
Purpose: To determine the safety and efficacy of difluprednate compared with prednisolone acetate in the treatment of endogenous anterior uveitis
Design: Multicenter, Randomized, Double-masked, Parallel-group, Active-controlled
Number of Patients: 90
Inclusion Criteria: Age ≥2 years or older; Diagnosis of endogenous anterior uveitis in at least 1 eye
Exclusion Criteria: Presence of intermediate uveitis, posterior uveitis, or panuveitis; corneal abrasion or ulceration; any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease; allergy to similar drugs, such as other corticosteroids
Contact: (813) 496-7325 ×300 or clinical. trials@siriontherapeutics.com

► Study: Phase 2 Study of MM-093 to Treat Patients With Uveitis
Sponsor: Merrimack Pharmaceuticals
Status: Currently enrolling
Purpose: To evaluate the tolerability, pharmacokinetics, pharmacodynamics, and biologic activity of MM-093 in patients with moderate to severe uveitis
Design: Treatment, Randomized, Doubleblind, Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Documented diagnosis of sarcoid or birdshot uveitis for at least 6 months as defined by each of the following: inflammatory cells in the anterior chamber and/or vitreous body ≥2+; and loss of visual function as reflected by a prolongation of 30 Hz scotopic implicit time on ERG testing and/or loss of vision to the 20/40 level or lower on visual acuity testing for patients with birdshot retinochoroidopathy
Exclusion Criteria: Significant concurrent medical disease or prior medications or treatments up to 2 months before study begins
Information: (617) 441-1000

► Study: Immune Indicators of Uveitis
Sponsor: National Eye Institute
Status: Enrolling patients Purpose To identify markers of immune activity in uveitis patients that correlate with the state of disease activity.
Design: Observational
Number of Patients: 100
Inclusion Criteria: Patients with bilateral sight-threatening uveitis requiring systemic immunotherapy who are 18 years and older are eligible. Disease can be active or quiescent, but subjects must be on a minimum prescribed therapy upon enrollment of a dose averaging at least 20 mg/day (or greater than or equal to 0.25 mg/kg/day) of systemic prednisone or a more intensive immunosuppression regimen. More intensive regimens may include from 1 to 3 antiinflammatory treatments for uveitis that include any 1 of the following (or related) compounds: corticosteroids (including systemic or periorbital administration), topical corticosteroids (when used in combination with other agents), cyclophosphamide, cyclosporine, azathioprine, chlorambucil, tacrolimus, leflunomide, mycophenolate mofetil, or methotrexate; patients who have noninfectious intermediate, posterior, or panuveitis of at least 3 months duration. Included conditions may include but are not limited to intermediate uveitis of the pars planitis subtype, sarcoidosis, the Vogt-Koyanagi-Harada (VKH) syndrome, birdshot retinochoroidopathy, retinal UVEITIS vasculitis and sympathetic ophthalmia
Exclusion Criteria: Pregnancy; having another disease or condition affecting vision that will interfere with obtaining study data
Information: prpl@mail.cc.nih.gov

► Study: Quality of Life and Visual Function in Uveitis Patients
Sponsor: New York Eye and Ear Infirmary
Status: Currently enrolling
Purpose: To measure the quality of visual function and quality of daily living in patients with anterior, posterior, and panuveitis
Design: Screening, Cross-sectional, Defined-population, Prospective Study
Number of Patients: 50
Inclusion Criteria: Age >18 years old; diagnosis of uveitis
Information: (212) 979-4251

► Study: Safety, Tolerability, and Efficacy of AEB071 in the Treatment of Uveitis
Sponsor: Novartis
Status: Currently enrolling
Purpose: To assess the efficacy of AEB071 300 mg twice daily as a therapy for uveitis, using reduction in swelling of the retina as a primary endpoint
Design: Treatment, Randomized, Double-blind (Subject, Investigator), Placebo-control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 40
Inclusion Criteria: Male and female patients with noninfectious intermediate or posterior uveitis or panuveitis in at least one eye, age 18 to 70 years of age inclusive, who are otherwise in good health; macular edema with average central retinal thickness >300 μm that was determined to have been present for less than 12 months; vitreous haze score >0.5, but <3 (based on the National Eye Institute grading system); BCVA no worse than 20/400 and no better than 20/40
Exclusion Criteria: Patients with CNV; Patients who had a prior vitrectomy; any eye condition that may affect the evaluation of VA and retinal thickness; concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol); use of systemic medications known to be toxic to the lens, retina, or optic nerve (eg, deferoxamine, chloroquine, and ethambutol) currently or in the past 6 months
Information: (862) 778-8300

► Study: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To examine the proteins of people with uveitis, or inflammation of the eyes. Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back of the lens, is now possible with the use of new microtechnology. There is an opportunity to evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening uveitis
Design: Observational
Number of Patients: 5
Inclusion Criteria: Patients meet the criteria for entry into the MUST study and have been randomized to receive a steroid implant; those who are in other studies must participate in a study that permits the evaluation of specimens
Exclusion Criteria: Patients who have met the criteria for participation in the MUST study and do not wish to donate their vitreous specimen or blood sample; those in other studies who wish to participate but do not wish to have their specimens evaluated
Information: prpl@mail.cc.nih.gov

► Study: Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Retinal Diseases
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To study epigenetic mechanisms, the inheritance of (both Mendelian and complex) and biomarkers of immune-mediated eye diseases, in families of many nationalities and ethnic backgrounds in order to identify the genes that, when mutated or demethylated or aceytylated, cause immune mediated eye disease, and the pathophysiology through which they act
Design: Observational
Number of Patients: 500
Inclusion Criteria: Individuals or family members of individuals with immunemediated retinal disorders, including uveitis, AMD, and diabetic retinopathy; children must be older than 4 years of age
Exclusion Criteria: Individuals with diseases, infections, or trauma that mimic immune medicated retinal disorders
Information: prpl@mail.cc.nih.gov

► Study: LIME: Lucentis for Inflammatory Macular Edema Trial
Sponsor: University of California, San Francisco/Genentech
Status: Currently enrolling
Purpose: To determine if ranibizumab, an FDA-approved treatment for neovascular age-related macular degeneration, is an effective treatment for those patients with uveitis-induced CME who are unable to be treated with or are non-responsive to steroids
Design: Treatment, Open-label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: History of noninfectious uveitis with chronic cystoid macular edema (> 3 months duration); anterior chamber and vitreous inflammation at the trace or below level according to the standardized classification of inflammation; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Exclusion Criteria: Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study. Study subjects will be allowed to continue their immunomodulatory treatment for uveitis throughout the study; previous vitrectomy; active intraocular inflammation in the study eye (greater than trace anterior chamber or vitreous cells); current vitreous hemorrhage; active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye; intraocular pressure >30 mm Hg despite treatment with glaucoma medications; blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by antihypertensive treatment, the subject can become eligible
Information: kevin.hong@ucsf.edu

OTHER
► Study: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration Sponsor: Ophthalmic Consultants of Boston/Genentech Status: Currently enrolling Purpose: To determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other than wet macular degeneration Design: Treatment, Randomized, Singleblind, Dose-comparison, Factorial Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Active CNV Exclusion Criteria: Pregnancy, agerelated macular degeneration, current eye infection or recent eye surgery, participating in other eye studies Information: (617) 573-1021

OTHER

► Study: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration
Sponsor: Ophthalmic Consultants of Boston/Genentech
Status: Currently enrolling
Purpose: To determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other than wet macular degeneration
Design: Treatment, Randomized, Singleblind, Dose-comparison, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Active CNV
Exclusion Criteria: Pregnancy, agerelated macular degeneration, current eye infection or recent eye surgery, participating in other eye studies
Information: (617) 573-1021

COMPLETED ENROLLMENT
► Study: OMEGA: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration Sponsor: Othera Pharmaceuticals Information: clinicaltrials@othera.com ► Study: OT-551 Antioxidant Eyedrops to Treat Geographic Atrophy in Dry Age-Related Macular Degeneration Sponsor: National Eye Institute Information: (800) 411-1222 ► Study: The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study Sponsor: National Eye Institute/National Institutes of Health/Department of Health and Human Services Information: (301) 251-1161 ► Study: Topical Ocular Mecamylamine in Diabetic Macular Edema (DME) Sponsor: CoMentis/Juvenile Diabetes Foundation Information: (410) 502-0768 ► Study: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial Sponsor: Johns Hopkins University/Genentech Contact: (443) 257-9692 ► Study: A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration Sponsor: Allergan Information: clinicaltrials@allergan.com ► Study: FAME (Fluocinolone Acetonide in Macular Edema) Sponsor: Alimera Sciences & Controlled Delivery Systems Information: www.alimerasciences.com ► Study: Reduction in the Occurrence of Center-threatening DME Sponsor: Eli Lilly and Company Information: (877) 285-4559 ► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema Sponsor: Diabetic Retinopathy Clinical Research Network Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolI_lrtdme/ProtIInfo.html ► Study: Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser Sponsor: Ophthalmic Consultants of Boston/ISTA Pharmaceuticals Information: prpl@mail.cc.nih.gov ► Study: SITE: Systemic Immuno-suppressive Therapy for Eye Diseases Cohort Study Sponsor: National Eye Institute Information: (800) 411-1222 ► Study: RADICAL: Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions Sponsor: QLT, Inc. Information: (604) 707-7000

COMPLETED ENROLLMENT

► Study: OMEGA: Use of Eye Drops to Treat Geographic Atrophy Associated With Age-Related Macular Degeneration
Sponsor: Othera Pharmaceuticals
Information: clinicaltrials@othera.com

► Study: OT-551 Antioxidant Eyedrops to Treat Geographic Atrophy in Dry Age-Related Macular Degeneration
Sponsor: National Eye Institute
Information: (800) 411-1222

► Study: The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study
Sponsor: National Eye Institute/National Institutes of Health/Department of Health and Human Services
Information: (301) 251-1161

► Study: Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)
Sponsor: CoMentis/Juvenile Diabetes Foundation
Information: (410) 502-0768

► Study: Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
Sponsor: Johns Hopkins University/Genentech
Contact: (443) 257-9692

► Study: A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Sponsor: Allergan
Information: clinicaltrials@allergan.com

► Study: FAME (Fluocinolone Acetonide in Macular Edema)
Sponsor: Alimera Sciences & Controlled Delivery Systems
Information: www.alimerasciences.com

► Study: Reduction in the Occurrence of Center-threatening DME
Sponsor: Eli Lilly and Company
Information: (877) 285-4559

► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide in Combination with Laser Photocoagulation for Diabetic Macular Edema
Sponsor: Diabetic Retinopathy Clinical Research Network
Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolI_lrtdme/ProtIInfo.html

► Study: Safety Study of Bromfenac Ophthalmic Solution in Subjects With Diffuse Diabetic Macular Edema (DME) Refractory to Laser
Sponsor: Ophthalmic Consultants of Boston/ISTA Pharmaceuticals
Information: prpl@mail.cc.nih.gov

► Study: SITE: Systemic Immuno-suppressive Therapy for Eye Diseases Cohort Study
Sponsor: National Eye Institute
Information: (800) 411-1222

► Study: RADICAL: Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions
Sponsor: QLT, Inc.
Information: (604) 707-7000

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Clinical Trials Update

CLINICAL TRIAL UPDATE

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