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: 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 VA 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 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 ► Study: Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration Sponsor: National Eye Institute Purpose: To investigate the safety and possible efficacy of multiple sirolimus subconjunctival injections in participants with bilateral GA Design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study Number of Patients: 15 Inclusion Criteria: Participant must have at least 1/2 disc area (approximately 1 mm²) of GA compatible with AMD present in each eye. GA is defined as one or more well-defined, usually more or less circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may still be classified as early GA Exclusion Criteria: Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (eg, diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.); history of macular laser, photodynamic therapy (PDT), intravitreal injection of any agent or any previous treatment for AMD other than high-dose vitamin supplementation Information: prpl@mail.cc.nih.gov ► Study: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-Related Macular Degeneration (AMD) Sponsor: Allergan Purpose: To evaluate the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from AMD. Patients will be followed for up to 2 years Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study Number of Patients: 95 Inclusion Criteria: Geographic atrophy in both eyes due to AMD; VA between 20/40 to 20/320 Exclusion Criteria: Known allergy to brimonidine; uncontrolled systemic disease or infection of the eye; recent eye surgery or injections in the eye Information: clinicaltrials@allergan.com ► Study: Fluocinolone Acentonide Intravitreal Inserts in Geographic Atrophy Sponsor: Alimera Sciences Purpose: To compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study Number of Patients: 40 Inclusion Criteria: Clinical diagnosis bilateral GA secondary to AMD of . 0.5 and . 7 MPS disc areas; males and nonpregnant females 55 years old or older Exclusion Critieria: GA secondary to any condition other than AMD in either eye; history of or current CNV in either eye or the need for anti-angiogenic therapy; glaucoma or ocular hypertension (IOP >21 mm Hg OR concurrent therapy at screening with IOP-lowering agents) in either eye; treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye; any change in systemic steroid therapy within 3 months of screening Information: lschulz@med.wayne.edu

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: 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 VA 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
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

► Study: Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated With Age-Related Macular Degeneration
Sponsor: National Eye Institute
Purpose: To investigate the safety and possible efficacy of multiple sirolimus subconjunctival injections in participants with bilateral GA
Design: Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 15
Inclusion Criteria: Participant must have at least 1/2 disc area (approximately 1 mm²) of GA compatible with AMD present in each eye. GA is defined as one or more well-defined, usually more or less circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may still be classified as early GA
Exclusion Criteria: Participant has evidence of ocular disease other than AMD in either eye that may confound the outcome of the study (eg, diabetic retinopathy with 10 or more hemorrhages or microaneurysms, uveitis, pseudovitelliform macular degeneration, moderate/severe myopia, etc.); history of macular laser, photodynamic therapy (PDT), intravitreal injection of any agent or any previous treatment for AMD other than high-dose vitamin supplementation
Information: prpl@mail.cc.nih.gov

► Study: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-Related Macular Degeneration (AMD)
Sponsor: Allergan
Purpose: To evaluate the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from AMD. Patients will be followed for up to 2 years
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 95
Inclusion Criteria: Geographic atrophy in both eyes due to AMD; VA between 20/40 to 20/320
Exclusion Criteria: Known allergy to brimonidine; uncontrolled systemic disease or infection of the eye; recent eye surgery or injections in the eye
Information: clinicaltrials@allergan.com

► Study: Fluocinolone Acentonide Intravitreal Inserts in Geographic Atrophy
Sponsor: Alimera Sciences
Purpose: To compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 40
Inclusion Criteria: Clinical diagnosis bilateral GA secondary to AMD of . 0.5 and . 7 MPS disc areas; males and nonpregnant females 55 years old or older
Exclusion Critieria: GA secondary to any condition other than AMD in either eye; history of or current CNV in either eye or the need for anti-angiogenic therapy; glaucoma or ocular hypertension (IOP >21 mm Hg OR concurrent therapy at screening with IOP-lowering agents) in either eye; treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye; any change in systemic steroid therapy within 3 months of screening
Information: lschulz@med.wayne.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 Exclusion Criteria: Subfoveal scar or subfoveal atrophy; significant media opacities, including cataract, which might interfere with visual acuity Information: (866) 622-8436 ► 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 and angiography 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 anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.); previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0; history of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye; previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals) Contact: (301) 986-8747 ► Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration Sponsor: Novartis/Greater Houston Retinal Research 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; prior enrollment in any study for AMD; ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment or macular hole; concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period; aphakia or absence of the posterior capsule in the study eye; previous violation of the posterior capsule is also excluded unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation; history of idiopathic or autoimmune uveitis in either eye; significant structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s); vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT; ocular inflammation (including trace or above) in the study eye; uncontrolled glaucoma (defined as intraocular pressure .30 mm Hg despite treatment with anti-medications) or previous filtration surgery in the study eye; infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection Information: http://www.houstonretina.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; history 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 <50% of the total lesion size 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 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 fluorescein angiographic (FA) features; the lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself; visual acuity of 20/60 or worse in the study eye as measured on an ETDRS chart; retinal photographs and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained Exclusion Criteria: Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; cataract surgery within three months of enrolment; presence of hemorrhage greater than 50% of the CNV lesion; previous PDT treatment in the study eye (eye to be treated) within 30 days prior to enrollment in the study; previous extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye (eye to be treated) is allowed, if performed at least 30 days prior to enrollment in the study; previous Macugen (pegaptanib) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study; previous Lucentis (ranibizumab) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study; previous Avastin (bevacizumab) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study; previous corticosteroid injection in the study eye (eye to be treated) within 180 days prior to enrollment in the study; history of peribulbar corticosteroid injection within 6 months prior to the start of the trial 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 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 of <12 total disc areas (21.24 mm²), and a GLD ≥5.4 mm 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: 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 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 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 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 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: Best-corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal CNV due to AMD 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 RPE detachment without the presence of neovascularization 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 AMD 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; VA 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 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) 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 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); sub-retinal 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 anti-inflammatory 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 Exclusion Criteria: CNV in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc. Information: (800) 411-1222 ► 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 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 Exclusion Criteria: Pregnant, lactating females or females of childbearing potential; glaucoma or ocular hypertension (defined as IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents) in the study eye 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: Intermediate or advanced AMD; any race and either sex Exclusion Criteria: History of a medical condition that would preclude scheduled study visits or completion of the study; history of an ophthalmic disease in the study eye that would likely compromise the VA of the study eye Information: paul.sternberg@vanderbilt.edu ► Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Related Macular Degeneration Sponsor: National Eye Institute 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 diagnosed with AMD in at least one eye defined by the presence of drusen at least 63 μm in size; must have CNV secondary to AMD 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 Information: prpl@mail.cc.nih.gov ► Study: ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis 0.5mg/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 one 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; 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; 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. Patients with results outside these ranges may be enrolled in consultation with Ophthotech Information: dbeutelspacher@ophthotech.com ► 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: Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT Exclusion Criteria: Patients receiving prior treatment in the study eye with verteporfin 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 PDT and Ranibizumab has similar efficacy to Ranibizumab alone Design: Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment Number of Patients: 20 Inclusion Criteria: FA diagnosis of CNV lesions as described above Exclusion Criteria: Dense subfoveal hemorrhage; tear or rip of the RPE, idiopathic parafoveal telangiectasis or serous RPE without 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 Exclusion Criteria: Pregnancy; prior enrollment in a ranibizumab clinical trial; previous therapy in either eye for AMD; concurrent eye disease that could compromise visual acuity Information: jeanette.buehler@hsc.utah.edu ► Study: Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration Sponsor: MacuSight, Inc. Purpose: To determine the safety and efficacy of an ocular sirolimus formulation via different injection routes in patients with treatment-naive subfoveal CNV secondary to AMD Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study Number of Patients: 20 Inclusion Criteria: Diagnosed with subfoveal CNV secondary to AMD; visual acuity of 20/50 to 20/200 in study eye Exclusion Criteria: Any other ocular disease that could compromise vision in the study eye; history of any prior treatment for choroidal neovascularization in the study eye; presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration Information: ebaj@retinalconsultantsaz.com ► Study: Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-Related Macular Degeneration Sponor: Lpath, Inc. Purpose: To assess the safety of iSONEP which is a humanized monoclonal antibody against a bioactive lipid, sphingosine 1-phosphate (S1P) Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 33 Inclusion Criteria: 50 years and older; BCVA ETDRS letter score in study eye between 20-57 letters using ETDRS refraction (Snellen of 20/70-20/400); any CNV secondary to AMD in study eye, classic, minimally classic or occult with leakage on fluorescein angiography and intraretinal or subretinal fluid on OCT; visual acuity in fellow eye must be 20/800 or better at 4 meters Exclusion Criteria: Ocular disease other than CNV that could compromise vision in study eye; systemic immunosuppressive medication/therapy (eg, chemotherapy, steroids); uncontrolled hypertension and/or arrhythmias; QT/QTc interval measurement >450 msec; cancer within the last 2 years except superficial basal or squamous cell skin cancer or cervical carcinoma in situ; have angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>8 diopters) or CNV secondary to other causes than AMD; any additional ocular diseases which have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema and severe non-proliferative diabetic retinopathy; any intraocular or general surgery, including cataract surgery, within 2 months of Day 1; history of uveitis in either eye; any ocular or periocular infection within 4 weeks prior to Day 1; active ocular inflammation grade trace and above; cup to disc ratio >0.8, IOP >21 mm Hg in glaucoma subjects treated with more than 2 ocular hypotensive agents; previous pars plana vitrectomy or trabeculectomy in study eye; history of anterior vitrectomy; 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 Information: (270) 554-8929 ► Study: Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration Sponsor: Retina Macula Institute Purpose: To assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment Number of Patients: 45 Inclusion Criteria: Age greater or equal to 50 years old; patients with active neovascular AMD Exclusion Criteria: Participation in another simultaneous medical investigation or trial; concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); previous PDT therapy; previous intravitreal steroid therapy within last 3 months; previous anti-VEGF therapy in the past month Information: lillian.rmi@gmail.com ► Study: Combination Ranibizumab and Bromfenac for Neovascular Age-Related Macular Degeneration Sponsor: Oregon Health and Science University/Genentech Purpose: To see whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criteria: Age >50 years; patients with active neovascular AMD; if the patient has bilateral disease and qualifies for the study, both eyes may be included Exclusion Criteria: Concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); previous intravitreal steroid or anti-VEGF therapy within last 3 months; patients with a concurrent corneal epithelial disruption or erosion; patients with immune deficiencies that would affect the ability of the cornea to heal; patients with a known sensitivity to any component of the formulations under investigation Information: schainm@ohsu.edu ► Study: ERG/EOG Study in AMD Patients Treated With Ranibizumab Sponsor: Retina Center, Minnesota/Genentech Purpose: To focus on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD Design: Case-Only, Prospective Number of Patients: 10 Inclusion Criteria: Patients to be included in the study must have AMD with choroidal neovascularization; BCVA between 20/20 - 20/400; lesion size less than or equal to 12 MPS disc areas Exclusion Criteria: Media insufficient to obtain a view; other causes of CNV not related to AMD; active ocular or periocular infection; ocular surgery within 1 month prior to the study; any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated; participation in another simultaneous medical investigation or trial; media insufficient to obtain a view; other causes of CNV not related to AMD Information: vu@retinadocs.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
Exclusion Criteria: Subfoveal scar or subfoveal atrophy; significant media opacities, including cataract, which might interfere with visual acuity
Information: (866) 622-8436

► 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 and angiography
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 anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.); previous subfoveal focal laser photocoagulation involving the foveal center in the study eye; laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0; history of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye; previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
Contact: (301) 986-8747

► Study: LUV: Lucentis Utilizing Visudyne Combination Therapy in the Treatment of Age-Related Macular Degeneration
Sponsor: Novartis/Greater Houston Retinal Research
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; prior enrollment in any study for AMD; ocular disorders in the study eye that may confound interpretation of study results, including retinal detachment or macular hole; concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period; aphakia or absence of the posterior capsule in the study eye; previous violation of the posterior capsule is also excluded unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation; history of idiopathic or autoimmune uveitis in either eye; significant structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s); vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by OCT; ocular inflammation (including trace or above) in the study eye; uncontrolled glaucoma (defined as intraocular pressure .30 mm Hg despite treatment with anti-medications) or previous filtration surgery in the study eye; infectious blepharitis, keratitis, scleritis, or conjunctivitis (in either eye) or current treatment for serious systemic infection
Information: http://www.houstonretina.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; history 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 <50% of the total lesion size
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
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 fluorescein angiographic (FA) features; the lesion must contain some visible active CNV, but the active CNV need not be under the fovea itself; visual acuity of 20/60 or worse in the study eye as measured on an ETDRS chart; retinal photographs and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice, can be obtained
Exclusion Criteria: Choroidal neovascularization in the study eye associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.; decreased vision, in the study eye, due to retinal disease not attributable to CNV, such as nonexudative forms of AMD, geographic atrophy, inherited retinal dystrophy, uveitis or epiretinal membrane, a vitelliform-like lesion of the outer retina (eg, as in pattern dystrophies or basal laminar drusen), idiopathic parafoveal telangiectasis, or central serous retinopathy. Participants who have any additional ocular diseases that have irreversibly compromised or, during follow-up, could likely compromise the VA of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy; decreased vision, in the study eye, due to significant media opacity such as corneal disease or cataract, or opacity precluding photography of the retina; cataract surgery within three months of enrolment; presence of hemorrhage greater than 50% of the CNV lesion; previous PDT treatment in the study eye (eye to be treated) within 30 days prior to enrollment in the study; previous extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye (eye to be treated) is allowed, if performed at least 30 days prior to enrollment in the study; previous Macugen (pegaptanib) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study; previous Lucentis (ranibizumab) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study; previous Avastin (bevacizumab) injection in the study eye (eye to be treated) within 30 days prior to enrollment in the study; previous corticosteroid injection in the study eye (eye to be treated) within 180 days prior to enrollment in the study; history of peribulbar corticosteroid injection within 6 months prior to the start of the trial
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
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 of <12 total disc areas (21.24 mm²), and a GLD ≥5.4 mm
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: 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
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
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
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
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: Best-corrected visual acuity in the study eye between 20/40 and 20/320, and better or equal to 20/40 in the fellow eye using an ETDRS chart; subfoveal CNV due to AMD
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 RPE detachment without the presence of neovascularization
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 AMD 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; VA 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
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)
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
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); sub-retinal 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 anti-inflammatory 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
Exclusion Criteria: CNV in the study eye, associated with other ocular diseases such as pathologic myopia, ocular histoplasmosis or posterior uveitis, etc.
Information: (800) 411-1222

► 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 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
Exclusion Criteria: Pregnant, lactating females or females of childbearing potential; glaucoma or ocular hypertension (defined as IOP >21 mm Hg or concurrent therapy at screening with IOP-lowering agents) in the study eye
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: Intermediate or advanced AMD; any race and either sex
Exclusion Criteria: History of a medical condition that would preclude scheduled study visits or completion of the study; history of an ophthalmic disease in the study eye that would likely compromise the VA of the study eye
Information: paul.sternberg@vanderbilt.edu

► Study: High Speed Indocyanine Green Angiography Findings in Ranibizumab Treatment for Wet Age-Related Macular Degeneration
Sponsor: National Eye Institute
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 diagnosed with AMD in at least one eye defined by the presence of drusen at least 63 μm in size; must have CNV secondary to AMD
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
Information: prpl@mail.cc.nih.gov

► Study: ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis 0.5mg/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 one 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; 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; 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. Patients with results outside these ranges may be enrolled in consultation with Ophthotech
Information: dbeutelspacher@ophthotech.com

► 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: Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT
Exclusion Criteria: Patients receiving prior treatment in the study eye with verteporfin
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 PDT and Ranibizumab has similar efficacy to Ranibizumab alone
Design: Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment
Number of Patients: 20
Inclusion Criteria: FA diagnosis of CNV lesions as described above
Exclusion Criteria: Dense subfoveal hemorrhage; tear or rip of the RPE, idiopathic parafoveal telangiectasis or serous RPE without 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
Exclusion Criteria: Pregnancy; prior enrollment in a ranibizumab clinical trial; previous therapy in either eye for AMD; concurrent eye disease that could compromise visual acuity
Information: jeanette.buehler@hsc.utah.edu

► Study: Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
Sponsor: MacuSight, Inc.
Purpose: To determine the safety and efficacy of an ocular sirolimus formulation via different injection routes in patients with treatment-naive subfoveal CNV secondary to AMD
Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 20
Inclusion Criteria: Diagnosed with subfoveal CNV secondary to AMD; visual acuity of 20/50 to 20/200 in study eye
Exclusion Criteria: Any other ocular disease that could compromise vision in the study eye; history of any prior treatment for choroidal neovascularization in the study eye; presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration
Information: ebaj@retinalconsultantsaz.com

► Study: Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-Related Macular Degeneration Sponor: Lpath, Inc.
Purpose: To assess the safety of iSONEP which is a humanized monoclonal antibody against a bioactive lipid, sphingosine 1-phosphate (S1P)
Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 33
Inclusion Criteria: 50 years and older; BCVA ETDRS letter score in study eye between 20-57 letters using ETDRS refraction (Snellen of 20/70-20/400); any CNV secondary to AMD in study eye, classic, minimally classic or occult with leakage on fluorescein angiography and intraretinal or subretinal fluid on OCT; visual acuity in fellow eye must be 20/800 or better at 4 meters
Exclusion Criteria: Ocular disease other than CNV that could compromise vision in study eye; systemic immunosuppressive medication/therapy (eg, chemotherapy, steroids); uncontrolled hypertension and/or arrhythmias; QT/QTc interval measurement >450 msec; cancer within the last 2 years except superficial basal or squamous cell skin cancer or cervical carcinoma in situ; have angioid streaks, presumed ocular histoplasmosis syndrome, myopia (>8 diopters) or CNV secondary to other causes than AMD; any additional ocular diseases which have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema and severe non-proliferative diabetic retinopathy; any intraocular or general surgery, including cataract surgery, within 2 months of Day 1; history of uveitis in either eye; any ocular or periocular infection within 4 weeks prior to Day 1; active ocular inflammation grade trace and above; cup to disc ratio >0.8, IOP >21 mm Hg in glaucoma subjects treated with more than 2 ocular hypotensive agents; previous pars plana vitrectomy or trabeculectomy in study eye; history of anterior vitrectomy; 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
Information: (270) 554-8929

► Study: Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
Sponsor: Retina Macula Institute
Purpose: To assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes
Design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment
Number of Patients: 45
Inclusion Criteria: Age greater or equal to 50 years old; patients with active neovascular AMD
Exclusion Criteria: Participation in another simultaneous medical investigation or trial; concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); previous PDT therapy; previous intravitreal steroid therapy within last 3 months; previous anti-VEGF therapy in the past month
Information: lillian.rmi@gmail.com

► Study: Combination Ranibizumab and Bromfenac for Neovascular Age-Related Macular Degeneration
Sponsor: Oregon Health and Science University/Genentech
Purpose: To see whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone
Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 30
Inclusion Criteria: Age >50 years; patients with active neovascular AMD; if the patient has bilateral disease and qualifies for the study, both eyes may be included
Exclusion Criteria: Concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma); previous intravitreal steroid or anti-VEGF therapy within last 3 months; patients with a concurrent corneal epithelial disruption or erosion; patients with immune deficiencies that would affect the ability of the cornea to heal; patients with a known sensitivity to any component of the formulations under investigation
Information: schainm@ohsu.edu

► Study: ERG/EOG Study in AMD Patients Treated With Ranibizumab
Sponsor: Retina Center, Minnesota/Genentech
Purpose: To focus on the ERG and EOG tests to evaluate retinal responses to ranibizumab treatment in AMD
Design: Case-Only, Prospective
Number of Patients: 10
Inclusion Criteria: Patients to be included in the study must have AMD with choroidal neovascularization; BCVA between 20/20 - 20/400; lesion size less than or equal to 12 MPS disc areas
Exclusion Criteria: Media insufficient to obtain a view; other causes of CNV not related to AMD; active ocular or periocular infection; ocular surgery within 1 month prior to the study; any other condition the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated; participation in another simultaneous medical investigation or trial; media insufficient to obtain a view; other causes of CNV not related to AMD
Information: vu@retinadocs.com

SCREENING
► Study: Genetic Factors in AMD Sponsor: National Eye Institute Status: Enrolling patients Purpose: To examine whether certain poly morphisms predispose people to develop AMD Design: Screening Number of Patients: 400 Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss Information: (800) 411-1222 ► Study: Investigating Age-Related Macular Degeneration Sponsor: National Eye Institute Status: Enrolling patients Purpose: To examine an Amish community to investigate genetic factors in the development of AMD Design: Natural History Number of Patients: 1000 Inclusion Criteria: All Amish individuals, ≥50 years Information: (301) 496-6583 ► Study: Ultrasonic Evaluation of Ocular Tissues Sponsor: Weill Medical College of Cornell University/Riverside Research Institute Status: Currently enrolling Purpose: To improve diagnosis and treatment monitoring of ophthalmic disease by improving diagnostic ultrasound techniques Design: Screening, Cross-sectional, Defined-population, Retrospective/Prospective Study Number of Patients: 150 Inclusion Criteria: Have 1 of the following eye diseases: glaucoma, ocular tumors, AMD Information: (212) 746-6106

SCREENING

► Study: Genetic Factors in AMD
Sponsor: National Eye Institute Status: Enrolling patients
Purpose: To examine whether certain poly morphisms predispose people to develop AMD
Design: Screening
Number of Patients: 400
Inclusion Criteria: (AMD patients) Age ≥50 years; diagnosis of advanced AMD
Exclusion Criteria: Presence of retinal disease involving the photoreceptors and/or outer retinal layers other than AMD loss
Information: (800) 411-1222

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

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

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 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 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 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 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 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 within 3 months of screening Information: (888) 662-6728 ► 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 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 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 diabetic macular edema (DME) secondary to diabetic retinopathy Design: Supportive Care, Non-randomized, Open-label, Single Group Assignment, Safety/Efficacy Study Number of Patients: 18 Inclusion Criteria: 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 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 Exclusion Criteria: Participation in another simultaneous medical investigation or trial; pre-PRP clinically significant DME that would make the patient eligible for macular laser prior to PRP 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 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 Exclusion Criteria: Inability to obtain photographs, FA, or OCT to document CNV 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 diabetic macular edema 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 1 month of baseline Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; condition that, in the opinion of the investigator, would preclude participation in the study 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 ► Study: Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema Sponsor: Bp Consulting, Inc. Purpose: To determine if bromfenac reduces DME as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the working-aged population in the United States Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study Number of Patients: 50 Inclusion Criteria: Male or female >18 years of age scheduled to undergo argon laser therapy. Patients with DME and/or PDR as evidenced by ophthalmic examination and diagnostics, with either central macular or peripheral involvement Exclusion Criteria: Patients who received intra-vitreal/sub-tenon corticosteroid injections; macular scarring/fibrosis, advanced cataract, advanced glaucoma, retinal pigment epithelial detachments (RPEDs); other causes affecting visual improvement; allergy to bromfenac or NSAIDS; sensitivity to sulfite Information: michelle-bpconsulting@yahoo.com ► Study: Study Comparing Two Doses of Ranibizumab in the Treatment of Clinically Significant Diabetic Macular Edema Sponsor: Long Island Vitreoretinal Consultants Purpose: To evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab to those receiving 1.0mg Ranibizumab Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study Number of Patients: 50 Inclusion Criteria: Type I or Type II diabetic subjects; vision between 20/20 and 20/400; presence of Clinically Significant Diabetic Macular Edema Exclusion Criteria: Presence of any condition that would prevent clear visualization of the back of the eye; uncontrolled glaucoma; inflammation inside the eye; certain prior eye surgeries, other than cataract surgery; other eye diseases that may compromise the vision in the study eye Information: mschlameuss@longislandretina.com ► Study: Double-Masked Study of Safety and Efficacy of VEGF Trap-Eye in Subjects With DME Sponsor: Regeneron Pharmaceuticals/Bayer Purpose: To study the efficacy and safety of VEGF Trap-Eye in subjects with diabetic macular edema Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 200 Inclusion Critieria: Patients with clinically significant DME with central involvement; adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema; ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye 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 or periocular corticosteroids in the study eye within 3 months of screening; previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening; uncontrolled diabetes mellitus Information: maria.thurman@parexel.com ► Study: A Multi-Center Trial to Evaluate the Safety and Efficacy of Pegaptanib Sodium (Macugen®) Injected Into the Eye Every 6 Weeks for up to 2 Years for Macular Swelling Associated With Diabetes Sponsor: Pfizer Purpose: To test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study Number of Patients: 300 Inclusion Criteria: Diabetic macular edema and VA between 20/50 and 20/200 Exclusion Criteria: Recent laser therapy in the eye; recent signs of uncontrolled diabetes; blood pressure worse than 160/100; severe cardiac disease 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
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
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
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
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
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 within 3 months of screening
Information: (888) 662-6728

► 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
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
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 diabetic macular edema (DME) secondary to diabetic retinopathy
Design: Supportive Care, Non-randomized, Open-label, Single Group Assignment, Safety/Efficacy Study
Number of Patients: 18
Inclusion Criteria: 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
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
Exclusion Criteria: Participation in another simultaneous medical investigation or trial; pre-PRP clinically significant DME that would make the patient eligible for macular laser prior to PRP
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
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
Exclusion Criteria: Inability to obtain photographs, FA, or OCT to document CNV
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 diabetic macular edema
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 1 month of baseline
Exclusion Criteria: History of chronic renal failure requiring dialysis or kidney transplant; condition that, in the opinion of the investigator, would preclude participation in the study
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

► Study: Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema
Sponsor: Bp Consulting, Inc.
Purpose: To determine if bromfenac reduces DME as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the working-aged population in the United States
Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Number of Patients: 50
Inclusion Criteria: Male or female >18 years of age scheduled to undergo argon laser therapy. Patients with DME and/or PDR as evidenced by ophthalmic examination and diagnostics, with either central macular or peripheral involvement
Exclusion Criteria: Patients who received intra-vitreal/sub-tenon corticosteroid injections; macular scarring/fibrosis, advanced cataract, advanced glaucoma, retinal pigment epithelial detachments (RPEDs); other causes affecting visual improvement; allergy to bromfenac or NSAIDS; sensitivity to sulfite
Information: michelle-bpconsulting@yahoo.com

► Study: Study Comparing Two Doses of Ranibizumab in the Treatment of Clinically Significant Diabetic Macular Edema
Sponsor: Long Island Vitreoretinal Consultants
Purpose: To evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab to those receiving 1.0mg Ranibizumab
Design: Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 50
Inclusion Criteria: Type I or Type II diabetic subjects; vision between 20/20 and 20/400; presence of Clinically Significant Diabetic Macular Edema
Exclusion Criteria: Presence of any condition that would prevent clear visualization of the back of the eye; uncontrolled glaucoma; inflammation inside the eye; certain prior eye surgeries, other than cataract surgery; other eye diseases that may compromise the vision in the study eye
Information: mschlameuss@longislandretina.com

► Study: Double-Masked Study of Safety and Efficacy of VEGF Trap-Eye in Subjects With DME
Sponsor: Regeneron Pharmaceuticals/Bayer
Purpose: To study the efficacy and safety of VEGF Trap-Eye in subjects with diabetic macular edema
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 200
Inclusion Critieria: Patients with clinically significant DME with central involvement; adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema; ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye
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 or periocular corticosteroids in the study eye within 3 months of screening; previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening; uncontrolled diabetes mellitus
Information: maria.thurman@parexel.com

► Study: A Multi-Center Trial to Evaluate the Safety and Efficacy of Pegaptanib Sodium (Macugen®) Injected Into the Eye Every 6 Weeks for up to 2 Years for Macular Swelling Associated With Diabetes
Sponsor: Pfizer
Purpose: To test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy
Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Number of Patients: 300
Inclusion Criteria: Diabetic macular edema and VA between 20/50 and 20/200
Exclusion Criteria: Recent laser therapy in the eye; recent signs of uncontrolled diabetes; blood pressure worse than 160/100; severe cardiac disease
Information: (800) 718-1021

RETINAL VEIN OCCLUSION
► Study: RAVE: Rubeosis Anti-VEGF Trial for Ischemic Central Retinal Vein Occlusion Sponsor: Greater Houston Retina Research Status: Enrolling patients Purpose: To see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic CRVO Design: Treatment, Randomized, 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 >3 clock hours with IOP over 30 (neovascular glaucoma); any previous retinal laser photocoagulation to the study eye, any previous intravitreal injection in study eye (triamcinolone or other), or any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery); intracapsular cataract extraction (posterior capsule needs to be present); previous history of retinal detachment in study eye; any previous radiation treatments to head/neck; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study or significant diabetic retinopathy in the fellow eye (DME, proliferative diabetic retinopathy, or high-risk nonproliferative diabetic retinopathy); pregnancy Information: (713) 524-3434 ► Study: CRUISE: A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion Sponsor: Genentech Status: Currently enrolling Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVO 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 Status: Currently enrolling Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to BRVO 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 Status: Currently enrolling Purpose: To determine whether niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye Design: Treatment, 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; OSI Pharmaceuticals Status: Currently enrolling Purpose: Study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO) Design: Treatment, Randomized, 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 Status: Currently enrolling Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity Design: Treatment, Nonrandomized, 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 1 topical ocular anti-hypertensive 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 Status: Enrolling patients 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; visual acuity score greater than or equal to 34 letters (20/200) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity 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; uncontrolled hypertension; a condition that, in the opinion of the investigator would preclude participation in the study (ie chronic alcoholism, drug abuse); 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), age related macular degeneration (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
Status: Enrolling patients
Purpose: To see if total VEGF blockade will prevent neovascular glaucoma and eliminate the need for panretinal photocoagulation in patients with ischemic CRVO
Design: Treatment, Randomized, 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 >3 clock hours with IOP over 30 (neovascular glaucoma); any previous retinal laser photocoagulation to the study eye, any previous intravitreal injection in study eye (triamcinolone or other), or any previous vitrectomy in study eye (posterior or anterior associated with vitreous loss in cataract surgery); intracapsular cataract extraction (posterior capsule needs to be present); previous history of retinal detachment in study eye; any previous radiation treatments to head/neck; significant cardiovascular disease or cancer that would prevent follow-up visits or completion of the 12-month study or significant diabetic retinopathy in the fellow eye (DME, proliferative diabetic retinopathy, or high-risk nonproliferative diabetic retinopathy); pregnancy
Information: (713) 524-3434

► Study: CRUISE: A Study of the Efficacy and Safety of Ranibizumab Injection in Patients With Macular Edema Secondary to Central Retinal Vein Occlusion
Sponsor: Genentech
Status: Currently enrolling
Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to CRVO
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
Status: Currently enrolling
Purpose: To study the efficacy and safety of intravitreal ranibizumab compared with sham injections in subjects with macular edema secondary to BRVO
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
Status: Currently enrolling
Purpose: To determine whether niacin, a B vitamin, may act as a vasodilator to encourage earlier formation of collateral blood vessels that may serve to bypass the obstructed vein in the eye
Design: Treatment, 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; OSI Pharmaceuticals
Status: Currently enrolling
Purpose: Study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO)
Design: Treatment, Randomized, 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
Status: Currently enrolling
Purpose: To determine whether a fluocinolone acetonide sustained drug delivery implant is effective in the treatment of retinal vein occlusion that has caused persistent macular edema and decreased visual acuity
Design: Treatment, Nonrandomized, 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 1 topical ocular anti-hypertensive 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
Status: Enrolling patients
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; visual acuity score greater than or equal to 34 letters (20/200) and less than or equal to 73 letters (20/40) by the ETDRS visual acuity 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; uncontrolled hypertension; a condition that, in the opinion of the investigator would preclude participation in the study (ie chronic alcoholism, drug abuse); 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), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc.
Information: (212) 452-6965

UVEITIS
► 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: 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 1 eye Exclusion Criteria: Patients with CNV; Patients who had a prior vitrectomy; any eye condition that may affect the evaluation of VA and retinal thickness 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 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 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 immunemediated retinal disorders 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 Exclusion Criteria: Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study 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 Exclusion Criteria: Any concurrent medical condition unrelated to uveitis that requires immunosuppressive or immunomodulatory therapy Information: (862) 778-8300 ► Study: Corticosteroid Implant vs. Oral Corticosteroid Treatment for Uveitis Sponsor: National Eye Institute Purpose: To test whether a new corticosteroid implant is more effective for reducing eye inflammation in patients with uveitis than the standard treatment with oral corticosteroids Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study Number of Patients: 250 Inclusion Criteria: Diagnosis of active, recurrent, chronic non-infectious intermediate, posterior, or panuveitis Exclusion Criteria: Diabetes mellitus that is inadequately controlled, according to best medical judgment; known allergy to a required study medication; yncontrolled glaucoma Information: prpl@mail.cc.nih.gov

UVEITIS

► 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: 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 1 eye
Exclusion Criteria: Patients with CNV; Patients who had a prior vitrectomy; any eye condition that may affect the evaluation of VA and retinal thickness
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
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
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 immunemediated retinal disorders
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
Exclusion Criteria: Treatment for CME with oral or steroid injections, Macugen, or Avastin within 6 weeks prior to enrollment in this study
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
Exclusion Criteria: Any concurrent medical condition unrelated to uveitis that requires immunosuppressive or immunomodulatory therapy
Information: (862) 778-8300

► Study: Corticosteroid Implant vs. Oral Corticosteroid Treatment for Uveitis
Sponsor: National Eye Institute
Purpose: To test whether a new corticosteroid implant is more effective for reducing eye inflammation in patients with uveitis than the standard treatment with oral corticosteroids
Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Number of Patients: 250
Inclusion Criteria: Diagnosis of active, recurrent, chronic non-infectious intermediate, posterior, or panuveitis
Exclusion Criteria: Diabetes mellitus that is inadequately controlled, according to best medical judgment; known allergy to a required study medication; yncontrolled glaucoma
Information: prpl@mail.cc.nih.gov

OTHER
► Study: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration Sponsor: Ophthalmic Consultants of Boston/Genentech Purpose: To determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration Design: Treatment, Randomized, Single Blind, Dose Comparison, Factorial Assignment, Safety/Efficacy Study Number of Patients: 30 Inclusion Criterion: Active CNV Exclusion Criteria: Pregnancy; AMD; current eye infection or recent eye surgery; participating in other eye studies Information: jbankert@eyeboston.com

OTHER

► Study: Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration
Sponsor: Ophthalmic Consultants of Boston/Genentech
Purpose: To determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration
Design: Treatment, Randomized, Single Blind, Dose Comparison, Factorial Assignment, Safety/Efficacy Study
Number of Patients: 30 Inclusion Criterion: Active CNV
Exclusion Criteria: Pregnancy; AMD; current eye infection or recent eye surgery; participating in other eye studies
Information: jbankert@eyeboston.com

COMPLETED ENROLLMENT
► Study: Efficacy Study of Lucentis in the Treatment of DME Sponsor: Rocky Mountain Retina Consultants/Genentech Information: study@rmrc.xohost.com ► Study: Study of Difluprednate in the Treatment of Uveitis Sponsor: Sirion Therapeutics Information: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com ► Study: COBALT: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD Sponsor: Opko Health, Inc. Information: clinicaltrials@opko.com ► Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Sponsor: Novartis Information: Brandi Teske, bteske@westcoastretina.com ► Study: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration Sponsor: Allergan Information: clinicaltrials@allergan.com ► 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: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema Sponsor: Rocky Mountain Retina Consultants/Genentech Information: study@rmrc.xohost.com ► Study: MUST: Multicenter Uveitis Steroid Treatment Sponsor: National Eye Institute Information: (301) 451-2020 ► Study: Immune Indicators of Uveitis Sponsor: National Eye Institute Information: prpl@mail.cc.nih.gov ► Study: Study of Difluprednate in the Treatment of Uveitis Sponsor: Sirion Therapeutics Contact: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

COMPLETED ENROLLMENT

► Study: Efficacy Study of Lucentis in the Treatment of DME
Sponsor: Rocky Mountain Retina Consultants/Genentech
Information: study@rmrc.xohost.com

► Study: Study of Difluprednate in the Treatment of Uveitis
Sponsor: Sirion Therapeutics
Information: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

► Study: COBALT: Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD
Sponsor: Opko Health, Inc.
Information: clinicaltrials@opko.com

► Study: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
Sponsor: Novartis
Information: Brandi Teske, bteske@westcoastretina.com

► Study: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-VEGF Treatment in Patients With Age-Related Macular Degeneration
Sponsor: Allergan
Information: clinicaltrials@allergan.com

► 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: Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema
Sponsor: Rocky Mountain Retina Consultants/Genentech
Information: study@rmrc.xohost.com

► Study: MUST: Multicenter Uveitis Steroid Treatment
Sponsor: National Eye Institute
Information: (301) 451-2020

► Study: Immune Indicators of Uveitis
Sponsor: National Eye Institute
Information: prpl@mail.cc.nih.gov

► Study: Study of Difluprednate in the Treatment of Uveitis
Sponsor: Sirion Therapeutics
Contact: (813) 496-7325 ×300 or clinical.trials@siriontherapeutics.com

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