A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
NCT ID: NCT03972709
Last Updated: 2024-03-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
372 participants
INTERVENTIONAL
2019-06-03
2022-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Galegenimab Q4W
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.
Galegenimab
Intravitreal (ITV) injections of galegenimab
Sham Control Q4W
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
Sham control
Galegenimab Q8W
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.
Galegenimab
Intravitreal (ITV) injections of galegenimab
Sham Control Q8W
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.
Sham Control
Sham control
Interventions
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Galegenimab
Intravitreal (ITV) injections of galegenimab
Sham Control
Sham control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Previous laser photocoagulation or ITV anti-vascular endothelial growth factor (anti-VEGF) for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy.
* 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.
60 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Arizona Retina and Vitreous Consultants
Phoenix, Arizona, United States
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
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Vitreo Retinal Consultants
Wichita, Kansas, United States
Maine Eye Center
Portland, Maine, United States
The Retina Care Center
Baltimore, Maryland, United States
Johns Hopkins Hospital.
Baltimore, Maryland, United States
Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Mass Eye and Ear Infirmary
Boston, Massachusetts, United States
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States
Associated Retinal Consultants PC
Royal Oak, Michigan, United States
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
Edina, Minnesota, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, United States
The Retina Institute
St Louis, Missouri, United States
Sierra Eye Associates
Reno, Nevada, United States
Envision Ocular, LLC
Bloomfield, New Jersey, United States
Mid Atlantic Retina
Cherry Hill, New Jersey, United States
Retina Associates of NJ
Teaneck, New Jersey, United States
Retina Vitreous Center, PA
Toms River, New Jersey, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, United States
Ophthalmic Consultants of Long Island
Oceanside, New York, United States
Retina Associates of Western New York
Rochester, New York, United States
The Retina Consultants
Slingerlands, New York, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Charlotte Eye Ear Nose and Throat Associates PA
Charlotte, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Retina Assoc of Cleveland Inc
Cleveland, Ohio, United States
Cleveland Clinic Foundation; Cole Eye Institute
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Retina Associates of Cleveland - Middleburg Heights Location
Middleburg Heights, Ohio, United States
Retina Associates of Cleveland - Youngstown Location
Youngstown, Ohio, United States
Casey Eye Institute
Portland, Oregon, United States
Mid Atlantic Retina - Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Southeastern Retina Associates Chattanooga
Chattanooga, Tennessee, United States
Charles Retina Institute
Germantown, Tennessee, United States
Tennessee Retina PC
Nashville, Tennessee, United States
Retina Res Institute of Texas
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Austin Clinical Research LLC
Austin, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Rocky Mountain Retina
Salt Lake City, Utah, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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GR40973
Identifier Type: -
Identifier Source: org_study_id
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