Clinical Trials Update

CLINICAL TRIAL UPDATE

DRY AMD
► Study: Measuring Reading Rehabilitation Outcomes Sponsor: Dept. of Veterans Affairs 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; CNV ("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) 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 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; 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 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 CNV; any significant ocular disease (other than CNV) that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; inability to obtain photographs to document CNV, including difficulty with venous access; history of CNV 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 CNV; patient who has a history of uveitis, Coat's disease, diabetic retinopathy, glaucoma, or cataract Information: nradtke@prodigy.net ► Study: Safety and Tolerability of ACU-02 in Healthy Volunteers for Potential Therapy for Dry Age-related Macular Degeneration Sponsor: Acucela Inc. Purpose: To provide an initial evaluation of the safety and tolerability of single-dose oral administration of ACU-02 in healthy volunteers in dose-escalating cohorts Design: Phase I, Randomized, Double-masked, Placebo-controlled Dose-escalating Safety Study Number of Patients: Up to 30 Inclusion Criteria: Age >55 and <80 years; healthy as determined by medical history and physical examination Information: www.acucela.com

DRY AMD

► Study: Measuring Reading Rehabilitation Outcomes
Sponsor: Dept. of Veterans Affairs
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; CNV ("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)
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
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; 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
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 CNV; any significant ocular disease (other than CNV) that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome; inability to obtain photographs to document CNV, including difficulty with venous access; history of CNV 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 CNV; patient who has a history of uveitis, Coat's disease, diabetic retinopathy, glaucoma, or cataract
Information: nradtke@prodigy.net

► Study: Safety and Tolerability of ACU-02 in Healthy Volunteers for Potential Therapy for Dry Age-related Macular Degeneration
Sponsor: Acucela Inc.
Purpose: To provide an initial evaluation of the safety and tolerability of single-dose oral administration of ACU-02 in healthy volunteers in dose-escalating cohorts
Design: Phase I, Randomized, Double-masked, Placebo-controlled Dose-escalating Safety Study
Number of Patients: Up to 30
Inclusion Criteria: Age >55 and <80 years; healthy as determined by medical history and physical examination
Information: www.acucela.com

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 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 Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed CNV 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 and 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 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 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 Purpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMD Design: Treatment, Randomized, Open-label, 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 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. Purpose: To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection Design: Treatment, Nonrandomized, 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 Purpose: To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with Visudyne Design: Treatment, Randomized, Open-label, Active-control, Single Group Assignment, Safety/Efficacy Study Inclusion Criteria: Treatment-naïve 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; IOP 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@barnesretinainstitute.com ► Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration Sponsor: Potentia Pharmaceuticals, Inc. 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 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 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 Purpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment Design: Treatment, Nonrandomized, Open-label, 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; VA 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 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, Open-label, 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 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. 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, Double-blind, 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 IOP >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 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 Purpose: To study the efficacy and safety of VEGF-Trap-Eye in patients with neovascular AMD. Design: Treatment, Randomized, Double-blind, 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) 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 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: BCVA 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 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 Purpose: To test the safety, tolerability, and effectiveness of a higher dose (1.0 mg) of ranibizumab vs the standard dose (0.5 mg), in adults with age-related 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 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 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 Purpose: To evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients Design: Treatment, Randomized, Double-blind, 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 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 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. 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 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, Double-blind (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 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, Double-blind (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: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration Sponsor: National Eye Institute 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, Open-label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Age ≥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 CNV under the fovea determined by NEI Investigators; VA 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 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 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 AMD Design: Treatment, Randomized, Double-blind (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 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, Single-blind (Subject), Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Patients ≥50 years old; treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4 to 6 weeks apart) with no improvement in VA (worse or within 1 line better) or center subfield thickening (worse or within 30 μm better); BCVA 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 Information: ghafiz1@jhmi.edu ► Study: Antioxidant Systems and Age-Related Macular Degeneration Sponsor: Vanderbilt University/National Institutes of Health 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 VA of the study eye (eg, amblyopia, uncontrolled glaucoma with an IOP >30 mm Hg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis) 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 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 AMD Design: Prospective Number of Patients: 50 Inclusion Criteria: Must be ≥50 years old; must be diagnosed with AMD in at least 1 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 Information: prpl@mail.cc.nih.gov ► Study: Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration (SEIRA) Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech Purpose: To study a combination therapy using efalizumab and ranibizumab that could target the adhesion factors that precede angiogenesis and improve the outcome for AMD patients in combination with the anti-VEGF agent, ranibizumab Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment Number of Patients: 10 Inclusion Criteria: Demonstrate understanding of and ability to perform weekly self subcutaneous injections; subjects of either gender, age >50 years; BCVA in the study eye between 20/40 and 20/320; subfoveal choroidal neovascularization, secondary to age related macular degeneration; 6-10 anti-VEGF treatments allowed prior to enrollment; presence of subretinal fluid and/or cystoid retinal edema on OCT Exclusion Criteria: Pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or 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 Information: (212) 452-6965 ► Study: RC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration Sponsor: Ophthotech Corporation Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis 0.5 mg/eye, or with 1 induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study Number of Patients: 70 Inclusion Criteria: Subfoveal CNV due to AMD (ie, predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram Exclusion Criteria: Previous or concomitant therapy with intravitreous corticosteroids; any of the following underlying diseases including: diabetic retinopathy; history or evidence of severe cardiac disease (eg, NYHA Functional Class III or IV), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment Information: dbeutelspacher@ophthotech.com ► Study: Subretinal Lucentis for Hemorrhagic AMD Sponsor:William Beaumont Hospitals Purpose: To determine if the the subretinal Lucentis alone is beneficial: 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study Number of Patients: 10 Inclusion Criteria: Age over 50 years; vision 20/200 or worse; AMD with submacular hemorrhage; hemorrhage more than 25% of the lesion; fibrosis or scar not more than 25% of the entire lesion; hemorrhage less than 3 months old; vision loss occuring within 3 months Exclusion Criteria: Intraocular eye surgery within the previous 12 months; inability to obtain necessary eye photographs; systemic use of anti-VEGF agents; allergy to fluorescein dye; glaucoma filtering surgery; use of 2 or more treatments for glaucoma; lack of lens in the eye, or absence of a posterior capsule Information: tosentoski@beaumont.edu ► Study: Reduced Fluence PDT With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration Sponsor: Oklahoma State University Center for Health Sciences/Novartis Purpose: To compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative AMD Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Male or Female Patients >50 years of age; patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT; BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts; if both eyes are eligible, only 1 eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye Exclusion Criteria: Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab; neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease Information: (918) 747-7799 ► Study: Pilot Study Reduced Fluence PDT/Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-Related Macular Degeneration (AMD) Sponsor: Lahey Clinic Purpose: To determine if combination reduced fluence photodynamic therapy and Ranibizumab has similar efficacy to Ranibizumab (Lucentis) alone Design: Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment Number of Patients: 20 Inclusion Criteria: Male/female >50 years of age; FA diagnosis of CNV lesions as described above; BCVA letter score in the study eye between 72 and 24 letters (approximately 20/40 to 20/320) using ETDRS chart measured at 4 meters; central retinal (including lesion) thickness greater than or equal to 250 μm as measured by OCT Exclusion Criteria: Dense subfoveal hemorrhage (>50% of the lesion); tear or rip of the retina pigment epithelium, idiopathic parafoveal telangiectasis or serous pigment epithelial detachment without CNV; geographic atrophy involving the foveal center; subretinal fibrotic scar in the study eye greater than 25% of the lesion; presence of any condition in study eye other than AMD known to be associated with CNV Information: Avon.P.Stewart@Lahey.org ► Study: SEAGUL: Study Evaluating Genotypes Using Lucentis Sponsor: University of Utah/Genentech Purpose: To investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study Inclusion Criteria: Treatment-naive AMD patients; at least 50 years of age; VA between 20/40 and 20/320 Exclusion Criteria: Pregnancy; prior enrollment in a ranibizumab clinical trial; previous therapy in either eye for AMD; concurrent eye disease that could compromise VA Information: jeanette.buehler@hsc.utah.edu

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
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
Purpose: To determine if Lucentis combined with imatinib mesylate will help treatment in patients with newly diagnosed CNV
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 and 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
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
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
Purpose: To determine whether the combination of ranibizumab and PDT is an effective and safe treatment for AMD
Design: Treatment, Randomized, Open-label, 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
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.
Purpose: To determine the safety and pharmacokinetics of REDD14NP when administered as a single intravitreal injection
Design: Treatment, Nonrandomized, 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
Purpose: To determine the benefits, if any, of combination therapy with Lucentis plus reduced-fluence PDT with Visudyne
Design: Treatment, Randomized, Open-label, Active-control, Single Group Assignment, Safety/Efficacy Study
Inclusion Criteria: Treatment-naïve 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; IOP 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@barnesretinainstitute.com

► Study: ASaP: Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration
Sponsor: Potentia Pharmaceuticals, Inc.
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
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
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
Purpose: To understand whether genes or certain factors in the environment determine how eyes will respond to Lucentis (ranibizumab) treatment
Design: Treatment, Nonrandomized, Open-label, 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; VA 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
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, Open-label, 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
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.
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, Double-blind, 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 IOP >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
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
Purpose: To study the efficacy and safety of VEGF-Trap-Eye in patients with neovascular AMD.
Design: Treatment, Randomized, Double-blind, 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)
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
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: BCVA 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
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
Purpose: To test the safety, tolerability, and effectiveness of a higher dose (1.0 mg) of ranibizumab vs the standard dose (0.5 mg), in adults with age-related 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
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
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
Purpose: To evaluate the pharmacodynamic effect of pazopanib eye drops on the central retinal thickness of AMD patients
Design: Treatment, Randomized, Double-blind, 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
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
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.
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
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, Double-blind (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
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, Double-blind (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: Infliximab, Sirolimus and Daclizumab to Treat Age-Related Macular Degeneration
Sponsor: National Eye Institute
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, Open-label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Age ≥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 CNV under the fovea determined by NEI Investigators; VA 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
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
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 AMD
Design: Treatment, Randomized, Double-blind (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
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, Single-blind (Subject), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Patients ≥50 years old; treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4 to 6 weeks apart) with no improvement in VA (worse or within 1 line better) or center subfield thickening (worse or within 30 μm better); BCVA 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
Information: ghafiz1@jhmi.edu

► Study: Antioxidant Systems and Age-Related Macular Degeneration
Sponsor: Vanderbilt University/National Institutes of Health
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 VA of the study eye (eg, amblyopia, uncontrolled glaucoma with an IOP >30 mm Hg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis)
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
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 AMD
Design: Prospective
Number of Patients: 50
Inclusion Criteria: Must be ≥50 years old; must be diagnosed with AMD in at least 1 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
Information: prpl@mail.cc.nih.gov

► Study: Study of Efalizumab Combined With Intravitreal Ranibizumab in the Treatment of Age-Related Macular Degeneration (SEIRA)
Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech
Purpose: To study a combination therapy using efalizumab and ranibizumab that could target the adhesion factors that precede angiogenesis and improve the outcome for AMD patients in combination with the anti-VEGF agent, ranibizumab
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Number of Patients: 10
Inclusion Criteria: Demonstrate understanding of and ability to perform weekly self subcutaneous injections; subjects of either gender, age >50 years; BCVA in the study eye between 20/40 and 20/320; subfoveal choroidal neovascularization, secondary to age related macular degeneration; 6-10 anti-VEGF treatments allowed prior to enrollment; presence of subretinal fluid and/or cystoid retinal edema on OCT
Exclusion Criteria: Pregnancy (positive pregnancy test) or lactation; premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or 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
Information: (212) 452-6965

► Study: RC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
Sponsor: Ophthotech Corporation
Purpose: To evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis 0.5 mg/eye, or with 1 induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to AMD
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Number of Patients: 70
Inclusion Criteria: Subfoveal CNV due to AMD (ie, predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram
Exclusion Criteria: Previous or concomitant therapy with intravitreous corticosteroids; any of the following underlying diseases including: diabetic retinopathy; history or evidence of severe cardiac disease (eg, NYHA Functional Class III or IV), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment
Information: dbeutelspacher@ophthotech.com

► Study: Subretinal Lucentis for Hemorrhagic AMD
Sponsor:William Beaumont Hospitals
Purpose: To determine if the the subretinal Lucentis alone is beneficial: 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not
Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 10
Inclusion Criteria: Age over 50 years; vision 20/200 or worse; AMD with submacular hemorrhage; hemorrhage more than 25% of the lesion; fibrosis or scar not more than 25% of the entire lesion; hemorrhage less than 3 months old; vision loss occuring within 3 months
Exclusion Criteria: Intraocular eye surgery within the previous 12 months; inability to obtain necessary eye photographs; systemic use of anti-VEGF agents; allergy to fluorescein dye; glaucoma filtering surgery; use of 2 or more treatments for glaucoma; lack of lens in the eye, or absence of a posterior capsule
Information: tosentoski@beaumont.edu

► Study: Reduced Fluence PDT With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration
Sponsor: Oklahoma State University Center for Health Sciences/Novartis
Purpose: To compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative AMD
Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Male or Female Patients >50 years of age; patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT; BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts; if both eyes are eligible, only 1 eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye
Exclusion Criteria: Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab; neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease
Information: (918) 747-7799

► Study: Pilot Study Reduced Fluence PDT/Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-Related Macular Degeneration (AMD)
Sponsor: Lahey Clinic
Purpose: To determine if combination reduced fluence photodynamic therapy and Ranibizumab has similar efficacy to Ranibizumab (Lucentis) alone
Design: Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment
Number of Patients: 20
Inclusion Criteria: Male/female >50 years of age; FA diagnosis of CNV lesions as described above; BCVA letter score in the study eye between 72 and 24 letters (approximately 20/40 to 20/320) using ETDRS chart measured at 4 meters; central retinal (including lesion) thickness greater than or equal to 250 μm as measured by OCT
Exclusion Criteria: Dense subfoveal hemorrhage (>50% of the lesion); tear or rip of the retina pigment epithelium, idiopathic parafoveal telangiectasis or serous pigment epithelial detachment without CNV; geographic atrophy involving the foveal center; subretinal fibrotic scar in the study eye greater than 25% of the lesion; presence of any condition in study eye other than AMD known to be associated with CNV
Information: Avon.P.Stewart@Lahey.org

► Study: SEAGUL: Study Evaluating Genotypes Using Lucentis
Sponsor: University of Utah/Genentech
Purpose: To investigate whether the efficacy of Lucentis treatment for exudative age-related macular degeneration is associated with VEGF and HTRA1 DNA polymorphisms
Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Inclusion Criteria: Treatment-naive AMD patients; at least 50 years of age; VA between 20/40 and 20/320
Exclusion Criteria: Pregnancy; prior enrollment in a ranibizumab clinical trial; previous therapy in either eye for AMD; concurrent eye disease that could compromise VA
Information: jeanette.buehler@hsc.utah.edu

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 ► Study: Metabolic Mapping to Measure Retinal Metabolism Sponsor: National Eye Institute Status: Currently enrolling Purpose: To test whether a new noninvasive technique can quickly and precisely measure retinal metabolism (the amount of energy retinal cells use). The retina is the part of the eye that sends information to the brain Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study Number of Patients: 30 Inclusion Criteria: Presence of a natural lens in the study eye(s); media clarity, pupillary dilation, and cooperation sufficient to perform measurements; all participants will have the ability to read with at least 1 eye Exclusion Criteria: Cataract surgery in the study eye; glaucoma with evidence of optic nerve damage; chronic requirement for any systemic or ocular medication for other eye diseases other than AMD, DR, or VHL-disease; presence of implanted medical devices that may be affected by electromagnetic frequency (EMF) emissions. Although our equipment is CE or UL rated for EMF emissions it would be prudent to exclude people with implanted pacemakers, neural stimulators, and insulin pumps; arrhythmia as indicated in medical records, as this may result in instability in measurements; ocular disease (other than AMD, DR, or VHL) that confounds assessment of the retina. These include but are not limited to central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration 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

► Study: Metabolic Mapping to Measure Retinal Metabolism
Sponsor: National Eye Institute
Status: Currently enrolling
Purpose: To test whether a new noninvasive technique can quickly and precisely measure retinal metabolism (the amount of energy retinal cells use). The retina is the part of the eye that sends information to the brain
Design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Number of Patients: 30
Inclusion Criteria: Presence of a natural lens in the study eye(s); media clarity, pupillary dilation, and cooperation sufficient to perform measurements; all participants will have the ability to read with at least 1 eye
Exclusion Criteria: Cataract surgery in the study eye; glaucoma with evidence of optic nerve damage; chronic requirement for any systemic or ocular medication for other eye diseases other than AMD, DR, or VHL-disease; presence of implanted medical devices that may be affected by electromagnetic frequency (EMF) emissions. Although our equipment is CE or UL rated for EMF emissions it would be prudent to exclude people with implanted pacemakers, neural stimulators, and insulin pumps; arrhythmia as indicated in medical records, as this may result in instability in measurements; ocular disease (other than AMD, DR, or VHL) that confounds assessment of the retina. These include but are not limited to central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration
Information: (800) 411-1222

DIABETIC MACULAR EDEMA
► Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema Sponsor: Allergan Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of DME Design: Treatment, Randomized, Double-blind, 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 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, Single-blind, 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: Effect of Ruboxistaurin on Clinically Significant Macular Edema Sponsor: Eli Lilly and Company 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, Double-blind, 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 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, Single-blind, 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 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 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 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, Single-blind, 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 Purpose: To compare multiple doses of intravitreal microplasmin for nonsurgical PVD induction for treatment of patients with DME Design: Treatment, Randomized, Double-blind, 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 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 anti-angiogenic 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 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, Open-label, 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 DME 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 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, Open-label, 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 (DME) 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 Purpose: To evaluate the safety and efficacy of a single injection of NOVA63035 "Corticosteroid" administered at 1 of 3 doses in patients with DME secondary to diabetic retinopathy Design: Supportive Care, Non-randomized, Open-label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 18 Inclusion Criteria: Age ≥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 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, Open-label, 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 to 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 ► Study: Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema Sponsor: MacuSight, Inc. Purpose: To determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with DME Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo-control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 120 Inclusion Criteria: Diagnosis of diabetes mellitus; macular edema secondary to diabetic retinopathy; VA of 20/40 to 20/200 in study eye Exclusion Criteria: Any other ocular disease in the study eye; any intravitreal injections, posterior subtenons steroids, photocoagulation, or intraocular surgery in study eye within 90 days; capsulotomy of study eye within 30 days Information: cdelpouys@macusight.com ► Study: Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR) Sponsor: Retina Research Foundation Purpose: To determine if infliximab injections into the eye are safe Design: Treatment, Nonrandomized, Open Label, Single Group Assignment, Safety Study Number of Patients: 4 Inclusion Criteria: Age > 21 years; patients with active CNV secondary to AMD in the study eye that did not improve with conventional therapy; patients with refractory DME in the study eye that did not improve with conventional therapy; BCVA 20/70 or less as measured on an ETDRS chart Exclusion Criteria: Inability to obtain photographs, FA or OCT to document CNV, eg, due to media opacity, allergy to fluorescein dye or lack of venous access; aphakia or pseudophakia with the absence of posterior capsule (unless it resulted from a yttrium aluminum garner [YAG]) posterior capsulotomy); within 1 month prior to screening had YAG laser in the study eye; have had intravitreal anti-VEGF or intravitreal steroids in the last 6 weeks; have had previous pars plana vitrectomy in the study eye Information: (518) 533-6550 ► Study: Sirolimus to Treat Diabetic Macular Edema Sponsor: National Eye Institute Purpose: To test whether sirolimus, a drug approved to treat psoriasis and other conditions, can help patients with DME Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study Number of Patients: 8 Inclusion Criteria: Documented hemoglobin A1C 12% or less within one month of baseline Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; ccondition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure and glycemic control). Patients in poor glycemic control who, within the last four months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next four months should not be enrolled; participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry; history of cancer (other than a non-melanoma skin cancer) diagnosed within the past 5 years that could be worsened by immunosuppression; laboratory values outside normal limits and considered clinically significant by the investigator; blood pressure greater than 180/110 (systolic above 180 OR diastolic above 110); concurrent use of intravitreal anti-VEGF therapy or subtenon/intravitreal steroids in the fellow eye Information: (800) 411-1222 ► Study: DEGAS: Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema Sponsor: Pfizer Purpose: To evaluate the effectiveness of study drug in improving VA compared to laser treatment in the patients with DME Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study Number of Patients: 160 Inclusion Criteria: Patients with diabetes mellitus showing DME Exclusion Criteria: PDR in the study eye; receiving concomitant intravitreal anti-VEGF therapy Information: (800) 718-1021

DIABETIC MACULAR EDEMA

► Study: Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Sponsor: Allergan
Purpose: To evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of DME
Design: Treatment, Randomized, Double-blind, 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
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, Single-blind, 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: Effect of Ruboxistaurin on Clinically Significant Macular Edema
Sponsor: Eli Lilly and Company
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, Double-blind, 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
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, Single-blind, 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
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
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
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, Single-blind, 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
Purpose: To compare multiple doses of intravitreal microplasmin for nonsurgical PVD induction for treatment of patients with DME
Design: Treatment, Randomized, Double-blind, 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
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 anti-angiogenic 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
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, Open-label, 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 DME 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
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, Open-label, 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 (DME) 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
Purpose: To evaluate the safety and efficacy of a single injection of NOVA63035 "Corticosteroid" administered at 1 of 3 doses in patients with DME secondary to diabetic retinopathy
Design: Supportive Care, Non-randomized, Open-label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 18
Inclusion Criteria: Age ≥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
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, Open-label, 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 to 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

► Study: Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema
Sponsor: MacuSight, Inc.
Purpose: To determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with DME
Design: Treatment, Randomized, Double-blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo-control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 120
Inclusion Criteria: Diagnosis of diabetes mellitus; macular edema secondary to diabetic retinopathy; VA of 20/40 to 20/200 in study eye
Exclusion Criteria: Any other ocular disease in the study eye; any intravitreal injections, posterior subtenons steroids, photocoagulation, or intraocular surgery in study eye within 90 days; capsulotomy of study eye within 30 days
Information: cdelpouys@macusight.com

► Study: Intravitreal Infliximab for Diabetic Macular Edema (DME) and Choroidal Neovascularization (CNV) (ITVR)
Sponsor: Retina Research Foundation
Purpose: To determine if infliximab injections into the eye are safe
Design: Treatment, Nonrandomized, Open Label, Single Group Assignment, Safety Study
Number of Patients: 4
Inclusion Criteria: Age > 21 years; patients with active CNV secondary to AMD in the study eye that did not improve with conventional therapy; patients with refractory DME in the study eye that did not improve with conventional therapy; BCVA 20/70 or less as measured on an ETDRS chart
Exclusion Criteria: Inability to obtain photographs, FA or OCT to document CNV, eg, due to media opacity, allergy to fluorescein dye or lack of venous access; aphakia or pseudophakia with the absence of posterior capsule (unless it resulted from a yttrium aluminum garner [YAG]) posterior capsulotomy); within 1 month prior to screening had YAG laser in the study eye; have had intravitreal anti-VEGF or intravitreal steroids in the last 6 weeks; have had previous pars plana vitrectomy in the study eye
Information: (518) 533-6550

► Study: Sirolimus to Treat Diabetic Macular Edema
Sponsor: National Eye Institute
Purpose: To test whether sirolimus, a drug approved to treat psoriasis and other conditions, can help patients with DME
Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Number of Patients: 8
Inclusion Criteria: Documented hemoglobin A1C 12% or less within one month of baseline
Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; ccondition that, in the opinion of the investigator, would preclude participation in the study (eg, unstable medical status including blood pressure and glycemic control). Patients in poor glycemic control who, within the last four months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next four months should not be enrolled; participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry; history of cancer (other than a non-melanoma skin cancer) diagnosed within the past 5 years that could be worsened by immunosuppression; laboratory values outside normal limits and considered clinically significant by the investigator; blood pressure greater than 180/110 (systolic above 180 OR diastolic above 110); concurrent use of intravitreal anti-VEGF therapy or subtenon/intravitreal steroids in the fellow eye
Information: (800) 411-1222

► Study: DEGAS: Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema
Sponsor: Pfizer
Purpose: To evaluate the effectiveness of study drug in improving VA compared to laser treatment in the patients with DME
Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 160
Inclusion Criteria: Patients with diabetes mellitus showing DME
Exclusion Criteria: PDR in the study eye; receiving concomitant intravitreal anti-VEGF therapy
Information: (800) 718-1021

RETINAL VEIN OCCLUSION
► Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion Sponsor: Greater Houston Retina Research 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, Open-label, 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 Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVO Design: Treatment Number of Patients: 390 Inclusion Criteria: Foveal center-involved 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 Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to BRVO Design: Treatment Number of Patients: 390 Inclusion Criteria: Foveal center-involved 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 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, Nonrandomized, 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 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, Open-label, 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 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 VA 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 long-lasting 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 ► Study: Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech Purpose: To examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study Number of Patients: 45 Inclusion Criteria: Age >18 years; clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head; central macular edema present on clinical examination and OCT testing with a central point thickness > 250 μm; VA score greater than or equal to 34 letters (20/200) and less than or equal to 73 letters (20/40) by the ETDRS VA protocol; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography Exclusion Critieria: Participation in another simultaneous ocular investigation or trial Patient with uncontrolled hypertension Patient has a condition that, in the opinion of the investigator would preclude participation in the study (ie, chronic alcoholism, drug abuse) Patient has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy exam or OCT reveals evidence of vitreoretinal interface abnormality that may be contributing to the macular edema eye that in the investigator has no chance of improvement in visual acuity following resolution of macular edema (ie, subretinal fibrosis or geographic atrophy) Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION),AMD, retinal detachment, severe cataracts, etc. Information: (212) 452-6965

RETINAL VEIN OCCLUSION

► Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion
Sponsor: Greater Houston Retina Research
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, Open-label, 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
Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVO
Design: Treatment
Number of Patients: 390
Inclusion Criteria: Foveal center-involved 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
Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to BRVO
Design: Treatment
Number of Patients: 390
Inclusion Criteria: Foveal center-involved 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
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, Nonrandomized, 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
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, Open-label, 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
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 VA
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 long-lasting 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

► Study: Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema
Sponsor: Vitreous-Retina Macula Consultants of New York/Genentech
Purpose: To examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema
Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
Number of Patients: 45
Inclusion Criteria: Age >18 years; clinical evidence of perfused central retinal vein occlusion. A central retinal vein occlusion (CRVO) is defined as an eye that has retinal hemorrhages and a dilated retinal venous system in all 4 quadrants. Other evidence of a CRVO may include telangiectatic capillary bed and collateral vessels at the optic nerve head; central macular edema present on clinical examination and OCT testing with a central point thickness > 250 μm; VA score greater than or equal to 34 letters (20/200) and less than or equal to 73 letters (20/40) by the ETDRS VA protocol; media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Exclusion Critieria: Participation in another simultaneous ocular investigation or trial Patient with uncontrolled hypertension Patient has a condition that, in the opinion of the investigator would preclude participation in the study (ie, chronic alcoholism, drug abuse) Patient has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy exam or OCT reveals evidence of vitreoretinal interface abnormality that may be contributing to the macular edema eye that in the investigator has no chance of improvement in visual acuity following resolution of macular edema (ie, subretinal fibrosis or geographic atrophy) Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION),AMD, retinal detachment, severe cataracts, etc.
Information: (212) 452-6965

UVEITIS
► Study: MUST: Multicenter Uveitis Steroid Treatment Sponsor: National Eye Institute 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, Open-label, 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; IOP 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 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 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: Immune Indicators of Uveitis Sponsor: National Eye Institute 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. 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 Infirmar 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 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 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 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 immune-mediated 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 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 nonresponsive 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 CME (>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 ► Study: Safety, Tolerability, and Efficacy of AIN457 in the Treatment of Uveitis Sponsor: Novartis Purpose: To assess the safety, tolerability, and efficacy of intravenous AIN457 as a therapy for uveitis. To assess the ability of intravenous AIN457 to reduce intraocular inflammation, and to reduce oral prednisone or topical corticosteroid use in uveitis patients Design: Treatment, Open-label, Historical Control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 15 Inclusion Criteria: Male and female subjects age 18 to 75 (inclusive) years of age; patients with noninfectious uveitis requiring systemic immunosuppression with agents other than or in addition to prednisone, or patients with HLA-B27-associated anterior uveitis who would ordinarily be started on systemic prednisone; BCVA 20/40 or worse Exclusion Criteria: Any concurrent medical condition unrelated to uveitis that requires immunosuppressive or immunomodulatory therapy; uveitis that is so severe that, in the investigator's judgment, it is too risky to test an experimental drug; ocular disease that would interfere with ocular evaluations or that would complicate the treatment of the study eye; concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol) Information: (862) 778-8300

UVEITIS

► Study: MUST: Multicenter Uveitis Steroid Treatment
Sponsor: National Eye Institute
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, Open-label, 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; IOP 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
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
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: Immune Indicators of Uveitis
Sponsor: National Eye Institute
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.
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 Infirmar
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
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
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
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 immune-mediated 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
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 nonresponsive 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 CME (>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

► Study: Safety, Tolerability, and Efficacy of AIN457 in the Treatment of Uveitis
Sponsor: Novartis
Purpose: To assess the safety, tolerability, and efficacy of intravenous AIN457 as a therapy for uveitis. To assess the ability of intravenous AIN457 to reduce intraocular inflammation, and to reduce oral prednisone or topical corticosteroid use in uveitis patients
Design: Treatment, Open-label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 15
Inclusion Criteria: Male and female subjects age 18 to 75 (inclusive) years of age; patients with noninfectious uveitis requiring systemic immunosuppression with agents other than or in addition to prednisone, or patients with HLA-B27-associated anterior uveitis who would ordinarily be started on systemic prednisone; BCVA 20/40 or worse
Exclusion Criteria: Any concurrent medical condition unrelated to uveitis that requires immunosuppressive or immunomodulatory therapy; uveitis that is so severe that, in the investigator's judgment, it is too risky to test an experimental drug; ocular disease that would interfere with ocular evaluations or that would complicate the treatment of the study eye; concurrent use of certain immunosuppressive agents (specific washout periods for different agents are defined in the protocol)
Information: (862) 778-8300

COMPLETED ENROLLMENT
► Study: Age-Related Eye Disease Study II (AREDS II) Sponsor: National Eye Institute Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120 ► Study: Evaluation and Treatment of Patients with Retinal Disease Sponsor: National Eye Institute Contact: (800) 411-1222 ► Study: Screening for Studies on Retinovascular Diseases Sponsor: National Eye Institute Contact: (800) 411-1222 ► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy Sponsor: Diabetic Retinopathy Clinical Research Network Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpdr/ProtJInfo.html ► Study: LUMINATE: A Study of LX211 in Active Sight-Threatening, Noninfectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis Sponsor: Lux Biosciences, Inc. Information: clinicaltrials@luxbio.com ► Study: Phase 2 Study of MM-093 to Treat Patients With Uveitis Sponsor: Merrimack Pharmaceuticals Information: (617) 441-1000

COMPLETED ENROLLMENT

► Study: Age-Related Eye Disease Study II (AREDS II)
Sponsor: National Eye Institute
Information: http://www.nei.nih.gov/neitrials/viewStudyWeb.aspx?id=120

► Study: Evaluation and Treatment of Patients with Retinal Disease
Sponsor: National Eye Institute
Contact: (800) 411-1222

► Study: Screening for Studies on Retinovascular Diseases
Sponsor: National Eye Institute
Contact: (800) 411-1222

► Study: Intravitreal Ranibizumab or Triamcinolone Acetonide as Adjunctive Treatment to Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
Sponsor: Diabetic Retinopathy Clinical Research Network
Information: http://public.drcr.net/DRCRnetstudies/studies/ProtocolJ_lrtpdr/ProtJInfo.html

► Study: LUMINATE: A Study of LX211 in Active Sight-Threatening, Noninfectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Sponsor: Lux Biosciences, Inc.
Information: clinicaltrials@luxbio.com

► Study: Phase 2 Study of MM-093 to Treat Patients With Uveitis
Sponsor: Merrimack Pharmaceuticals
Information: (617) 441-1000

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