A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
- Conditions
- Macular Degeneration, Age-RelatedGeographic Atrophy
- Interventions
- Drug: Sham Control
- Registration Number
- NCT03972709
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 372
- 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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Galegenimab Q4W Galegenimab Participants will receive galegenimab every 4 weeks (Q4W). 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 injections. Sham Control Q4W Sham Control Participants will receive Sham-control Q4W. 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 injections. Sham Control Q8W Sham Control Participants will receive Sham-control Q8W. 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 injections. Galegenimab Q8W Galegenimab Participants will receive galegenimab every 8 weeks (Q8W). 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 injections.
- Primary Outcome Measures
Name Time Method Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) Baseline, Week 72 GA is an advanced stage of age-related macular degeneration (AMD) and is characterized by loss of photoreceptors, retinal pigment epithelium, and choriocapillaris. In the early stages of GA, patients typically show minimal changes in central visual acuity although patients often still experience significant symptoms from visual dysfunction, such as reduced contrast sensitivity, and a decrease in reading speed. In the later stages, as the GA lesion expands into the fovea, a profound decrease in central visual acuity occurs with a decline in activities of daily living. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of GA lesion area (worsening; disease progression).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Systemic Adverse Events From baseline to Week 76 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. Non-ocular AEs were the systemic events.
Percentage of Participants With Ocular Adverse Events in the Study Eye From baseline to Week 76 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 Ocular Adverse Events in the Fellow Eye From baseline to Week 76 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 Serious Adverse Events (SAEs) From baseline to Week 76 SAEs are defined as fatal, life threatening, requires or prolongs patient hospitalization, results in persistent or significant disability/incapacity, or is a significant medical event in the investigator's judgement.
Percentage of Participants With Adverse Events of Special Interest (AESIs) From baseline to Week 76 AESIs include 1.) cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law 2.) Suspected transmission of an infectious agent by galegenimab 3.) AEs resulting from medication error 4.) Sight-threatening AEs of the following criteria: It causes a decrease of \>= 30 letters in visual acuity (VA) score, compared with the most recent prior VA assessment, that lasts more than 1 hour and is attributable to galegenimab; it requires surgical intervention to prevent permanent loss of sight; associated with severe (Grade 4+) intraocular inflammation (IOI) and/or IOI-associated retinal vasculitis; in the opinion of the investigator, it may require medical intervention to prevent permanent loss of sight.
Percentage of Participants With Adverse Events Leading to Study Discontinuation From baseline to Week 76 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. Non-ocular AEs were the systemic events.
Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Under Low-luminance Conditions Baseline, Week 72 BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m) under low-luminance conditions. A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity.
Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart Baseline, Week 72 BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity.
Trial Locations
- Locations (71)
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Associated Retinal Consultants PC
🇺🇸Royal Oak, Michigan, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Georgia Retina PC
🇺🇸Marietta, Georgia, United States
Southeastern Retina Associates Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Retina Group of Washington
🇺🇸Chevy Chase, Maryland, United States
Mass Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Illinois Eye and Ear Infirmary
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Foundation; Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
Ophthalmic Consultants of Long Island
🇺🇸Oceanside, New York, United States
Tennessee Retina PC
🇺🇸Nashville, Tennessee, United States
Rocky Mountain Retina
🇺🇸Salt Lake City, Utah, United States
The Retina Partners
🇺🇸Encino, California, United States
Jules Stein Eye Institute/ UCLA
🇺🇸Los Angeles, California, United States
Johns Hopkins Hospital.
🇺🇸Baltimore, Maryland, United States
Midwest Vision Research Foundation
🇺🇸Chesterfield, Missouri, United States
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
🇺🇸Edina, Minnesota, United States
The Retina Consultants
🇺🇸Slingerlands, New York, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Charlotte Eye Ear Nose and Throat Associates PA
🇺🇸Charlotte, North Carolina, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
Mid Atlantic Retina - Wills Eye Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Retina Foundation of the Southwest
🇺🇸Dallas, Texas, United States
Retina Assoc of Cleveland Inc
🇺🇸Cleveland, Ohio, United States
Retina Associates of Cleveland - Youngstown Location
🇺🇸Youngstown, Ohio, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Retina Res Institute of Texas
🇺🇸Abilene, Texas, United States
Charles Retina Institute
🇺🇸Germantown, Tennessee, United States
Retina Associates Southwest PC
🇺🇸Tucson, Arizona, United States
Arizona Retina and Vitreous Consultants
🇺🇸Phoenix, Arizona, United States
Retina Consultants, San Diego
🇺🇸Poway, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
W Coast Retina Med Group Inc
🇺🇸San Francisco, California, United States
Retina Consultants of Southern Colorado PC
🇺🇸Colorado Springs, Colorado, United States
California Retina Consultants - Santa Maria
🇺🇸Santa Maria, California, United States
Southwest Retina Consultants
🇺🇸Durango, Colorado, United States
Rand Eye
🇺🇸Deerfield Beach, Florida, United States
Colorado Retina Associates, PC
🇺🇸Lakewood, Colorado, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Retina Vitreous Assoc of FL
🇺🇸Saint Petersburg, Florida, United States
Southern Vitreoretinal Associates
🇺🇸Tallahassee, Florida, United States
Maine Eye Center
🇺🇸Portland, Maine, United States
University Retina and Macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
Long Is. Vitreoretinal Consult
🇺🇸Hauppauge, New York, United States
Envision Ocular, LLC
🇺🇸Bloomfield, New Jersey, United States
Retina Vitreous Center, PA
🇺🇸Toms River, New Jersey, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Austin Clinical Research LLC
🇺🇸Austin, Texas, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Florida Eye Associates - Melbourne 2nd Office
🇺🇸Melbourne, Florida, United States
Wolfe Eye Clinic
🇺🇸West Des Moines, Iowa, United States
Retina Associates of NJ
🇺🇸Teaneck, New Jersey, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Mid Atlantic Retina
🇺🇸Cherry Hill, New Jersey, United States
Western Carolina Retinal Associate PA
🇺🇸Asheville, North Carolina, United States
Retina Associates of Cleveland - Middleburg Heights Location
🇺🇸Middleburg Heights, Ohio, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Casey Eye Institute
🇺🇸Portland, Oregon, United States
Retinal Consultants Med Group
🇺🇸Sacramento, California, United States
Vitreo Retinal Consultants
🇺🇸Wichita, Kansas, United States