A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Macular Degeneration, Age-Related, Geographic Atrophy
About this trial
This is an interventional treatment trial for Macular Degeneration, Age-Related
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Sites / Locations
- California Retina Consultants
- The Retina Partners
- Retina Consultants of Orange County
- Northern California Retina Vitreous Associates
- Retina Consultants, San Diego
- Retinal Consultants Med Group
- West Coast Retina
- California Retina Consultants
- California Retina Consultants - Santa Maria
- Bay Area Retina Associates
- Retina Consultants of Southern Colorado PC
- Southwest Retina Consultants
- Colorado Retina Associates, PC
- Rand Eye
- Florida Eye Associates - Melbourne 2nd Office
- Retina Specialty Institute
- Retina Vitreous Assoc of FL
- Southern Vitreoretinal Associates
- Southeast Retina Center
- Georgia Retina PC
- Illinois Eye and Ear Infirmary
- Wolfe Eye Clinic
- Vitreo Retinal Consultants
- Johns Hopkins University
- Vitreo-Retinal Associates
- Associated Retinal Consultants PC
- Midwest Vision Research Foundation
- The Retina Institute
- Sierra Eye Associates
- NJ Retina Teaneck Clinic
- NJ Retina-Toms River
- Ophthalmic Consultants of Long Island
- Western Carolina Retinal Associate PA
- Charlotte Eye Ear Nose and Throat Associates PA
- Cincinnati Eye Institute
- Cleveland Clinic Foundation; Cole Eye Institute
- Casey Eye Institute
- Mid Atlantic Retina - Wills Eye Hospital
- Palmetto Retina Center
- Southeastern Retina Associates Chattanooga
- Charles Retina Institute
- Tennessee Retina PC
- Austin Retina Associates
- Austin Clinical Research LLC
- Retina Foundation of the Southwest
- Retina Consultants of Texas
- Spokane Eye Clinical Research
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Galegenimab 20 mg Q4W
Galegenimab 20 mg Q8W
Galegenimab 10 mg Q4W
Galegenimab 10 mg Q8W
Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).
Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).
Participants will receive 10 mg galegenimab via ITV injection Q4W.
Participants will receive 10 mg galegenimab via ITV injection Q8W.