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

Stopped early · Phase 2

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

In brief

The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).

Key facts

Study ID

NCT04607148

Run by

Genentech, Inc.

People needed

144

Starts

2020-11-16

Expected to finish

2022-11-14

Last updated by the study team

2023-10-16

Who can join

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

You may qualify if…

• Completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation
• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging.
• Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (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) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study.
• Ocular Inclusion Criteria: Non-Study Eye
• The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study.

You may not qualify if…

• Ocular Exclusion Criteria:
• Active uveitis and/or vitritis (grade trace or above) in either eye
• Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Active or history of choroidal neovascularization (CNV) in study eye that requires anti-vascular endothelial growth factor (anti-VEGF) treatment
• Active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye
• Retinal pigment epithelium (RPE) tear that involves the macula in either eye
• Moderate or severe non-proliferative diabetic retinopathy in either eye
• Proliferative diabetic retinopathy in either eye
• Central serous retinopathy in either eye
• Recent history of recurrent infectious or inflammatory ocular disease in either eye
• Recent history of idiopathic or autoimmune-associated uveitis in either eye
• Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications.

Where it is running

• California Retina Consultants — Bakersfield, California, United States
• The Retina Partners — Encino, California, United States
• Retina Consultants of Orange County — Fullerton, 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
• West Coast Retina — 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
• Wolfe Eye Clinic — West Des Moines, Iowa, United States
• Vitreo Retinal Consultants — Wichita, Kansas, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Vitreo-Retinal Associates — Grand Rapids, Michigan, United States

Full record on ClinicalTrials.gov

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