A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Macular Degeneration, Age-Related, Geographic Atrophy

In brief

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.

Key facts

Study ID

NCT03972709

Run by

Genentech, Inc.

People needed

372

Starts

2019-06-03

Expected to finish

2022-10-27

Last updated by the study team

2024-03-27

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >/= 60 years at time of signing Informed Consent Form;
• Visual acuity: best-corrected visual acuity (BCVA) letter score >/= 24 letters (Snellen equivalent of 20/320 or better). If the study eye BCVA letter score is >/= 69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of >/= 44 letters (Snellen equivalent of 20/125 or better);
• Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.

You may not qualify if…

• Ocular Exclusion Criteria, Study Eye:
• History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD;
• Previous laser photocoagulation or ITV anti-vascular endothelial growth factor (anti-VEGF) for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy.
• Ocular Exclusion Criteria, Both Eyes:
• GA in either eye due to causes other than AMD;
• Active uveitis and/or vitritis (grade trace or above) in either eye;
• Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye;
• Retinal pigment epithelium (RPE) tear that involves the macula in either eye;
• Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, regardless of the route of administration (i.e., ocular or systemic) within the last 6 months.

Where it is running

• 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
• The Retina Partners — Encino, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Jules Stein Eye Institute/ UCLA — Los Angeles, California, United States
• Northern California Retina Vitreous Associates — Mountain View, California, United States
• Retina Consultants, San Diego — Poway, California, United States
• Retinal Consultants Med Group — Sacramento, California, United States
• W Coast Retina Med Group Inc — San Francisco, California, United States
• California Retina Consultants — Santa Barbara, California, United States
• California Retina Consultants - Santa Maria — Santa Maria, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Retina Consultants of Southern Colorado PC — Colorado Springs, Colorado, United States
• Southwest Retina Consultants — Durango, Colorado, United States
• Colorado Retina Associates, PC — Lakewood, Colorado, United States
• Rand Eye — Deerfield Beach, Florida, United States
• Florida Eye Associates - Melbourne 2nd Office — Melbourne, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Retina Vitreous Assoc of FL — St. Petersburg, Florida, United States
• Southern Vitreoretinal Associates — Tallahassee, Florida, United States
• Southeast Retina Center — Augusta, Georgia, United States
• Georgia Retina PC — Marietta, Georgia, United States
• Illinois Eye and Ear Infirmary — Chicago, Illinois, United States
• Arizona Retina and Vitreous Consultants — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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