A Study Investigating the Safety and Efficacy 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

NCT02247531

Run by

Hoffmann-La Roche

People needed

975

Starts

2014-10-06

Expected to finish

2018-01-23

Last updated by the study team

2019-10-15

Who can join

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

You may qualify if…

• Participants aged greater than or equal to (>/=) 50 years
• 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 (e.g., 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

• Retina Associates Southwest PC — Tucson, Arizona, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• UCSD Shiley Eye Center — La Jolla, California, United States
• Jules Stein Eye Institute/ UCLA — Los Angeles, California, United States
• N CA Retina Vitreous Assoc — Mountain View, California, United States
• Byers Eye Insitute at Stanford — Palo Alto, California, United States
• Retina Consultants, San Diego — Poway, California, United States
• University of California, Davis, Eye Center — Sacramento, California, United States
• Retinal Consultants Med Group — Sacramento, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• University of Colorado — Aurora, Colorado, United States
• Retina Consultants of Southern — Colorado Springs, Colorado, United States
• Colorado Retina Associates, PC — Golden, Colorado, United States
• New England Retina Associates — Hamden, Connecticut, United States
• Retina Group of New England — Waterford, Connecticut, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• Retina Health Center — Fort Myers, Florida, United States
• Bascom Palmer Eye Institute — Naples, Florida, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Southern Vitreoretinal Assoc — Tallahassee, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Associated Retina Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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