A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Geographic Atrophy

In brief

This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled study evaluating the efficacy and safety of lampalizumab administered by intravitreal injections in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Key facts

Study ID

NCT02247479

Run by

Hoffmann-La Roche

People needed

906

Starts

2014-09-18

Expected to finish

2018-01-29

Last updated by the study team

2019-06-26

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD) with no evidence of prior or active choroidal neovascularization (CNV) in both eyes

You may not qualify if…

• Ocular Exclusion Criteria: Study Eye
• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
• Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
• Previous intravitreal drug delivery (intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation) Ocular Exclusion Criteria: Both Eyes
• GA in either eye due to causes other than AMD
• Previous treatment with eculizumab, lampalizumab and/or fenretinide

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Retina Centers P.C. — Tucson, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• The Gavin Herbert Eye Institute - UC, Irvine — Irvine, California, United States
• Jules Stein Eye Institute/ UCLA — Los Angeles, California, United States
• East Bay Retina Consultants — Oakland, California, United States
• Southern CA Desert Retina Cons — Palm Desert, California, United States
• W Coast Retina Med Group Inc — San Francisco, California, United States
• UCSF; Ophthalmology — San Francisco, California, United States
• Orange County Retina Med Group — Santa Ana, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Florida Eye Microsurgical Inst — Boynton Beach, Florida, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Retina Care Specialists — Palm Beach Gardens, Florida, United States
• Bascom Palmer Eye Institute — Palm Beach Gardens, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Southern Vitreoretinal Assoc — Tallahassee, Florida, United States
• Retina Associates of Florida, LLC — Tampa, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina PC — Marietta, Georgia, United States
• Uni of Alabama At Birmingham Clinical Research Unit — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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