A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
- Conditions
- Macular Degeneration, Age-RelatedGeographic Atrophy
- Interventions
- Registration Number
- NCT04607148
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 144
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Galegenimab 20 mg Q4W Galegenimab Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W). Galegenimab 10 mg Q8W Galegenimab Participants will receive 10 mg galegenimab via ITV injection Q8W. Galegenimab 20 mg Q8W Galegenimab Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W). Galegenimab 10 mg Q4W Galegenimab Participants will receive 10 mg galegenimab via ITV injection Q4W.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Ocular Adverse Events From baseline up to Week 104 An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Percentage of Participants With Systemic (Non-Ocular) Adverse Events From Baseline up to Week 104 An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Southwest Retina Consultants
🇺🇸Durango, Colorado, United States
Florida Eye Associates - Melbourne 2nd Office
🇺🇸Melbourne, Florida, United States
Southeastern Retina Associates Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Cleveland Clinic Foundation; Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Western Carolina Retinal Associate PA
🇺🇸Asheville, North Carolina, United States
West Coast Retina
🇺🇸San Francisco, California, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Tennessee Retina PC
🇺🇸Nashville, Tennessee, United States
Colorado Retina Associates, PC
🇺🇸Lakewood, Colorado, United States
Retina Consultants of Southern Colorado PC
🇺🇸Colorado Springs, Colorado, United States
Vitreo Retinal Consultants
🇺🇸Wichita, Kansas, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Midwest Vision Research Foundation
🇺🇸Chesterfield, Missouri, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Charlotte Eye Ear Nose and Throat Associates PA
🇺🇸Charlotte, North Carolina, United States
Associated Retinal Consultants PC
🇺🇸Royal Oak, Michigan, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
NJ Retina Teaneck Clinic
🇺🇸Toms River, New Jersey, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Mid Atlantic Retina - Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
The Retina Partners
🇺🇸Encino, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Retina Consultants, San Diego
🇺🇸Poway, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
California Retina Consultants - Santa Maria
🇺🇸Santa Maria, California, United States
Rand Eye
🇺🇸Deerfield Beach, Florida, United States
Retina Specialty Institute
🇺🇸Pensacola, 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
Retinal Consultants Med Group
🇺🇸Sacramento, California, United States
Casey Eye Institute
🇺🇸Portland, Oregon, United States
Retina Vitreous Assoc of FL
🇺🇸Saint Petersburg, Florida, United States
Southern Vitreoretinal Associates
🇺🇸Tallahassee, Florida, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
NJ Retina-Toms River
🇺🇸Toms River, New Jersey, United States
Ophthalmic Consultants of Long Island
🇺🇸Oceanside, New York, United States
Austin Clinical Research LLC
🇺🇸Austin, Texas, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States