Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)

Stopped early · Phase 3

Conditions studied: Geographic Atrophy

In brief

This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

Key facts

Study ID

NCT02745119

Run by

Hoffmann-La Roche

People needed

994

Starts

2016-07-21

Expected to finish

2018-01-31

Last updated by the study team

2019-03-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit
• Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential

You may not qualify if…

• Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
• Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications
• Increased risk of infection
• Pregnancy or lactation

Where it is running

• Retinal Research Institute, LLC — Phoenix, Arizona, United States
• Associated Retina Consultants — Phoenix, Arizona, United States
• Retina Centers P.C. — Tucson, Arizona, United States
• Retina Associates Southwest PC — Tucson, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, 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
• East Bay Retina Consultants — Oakland, California, United States
• Southern CA Desert Retina Cons — Palm Desert, 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
• W Coast Retina Med Group Inc — San Francisco, California, United States
• UCSF Comprehensive Cancer Ctr; Ophthalmology — San Francisco, California, United States
• Orange County Retina Med Group — Santa Ana, 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
• Uni of Alabama At Birmingham Clinical Research Unit — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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