A Study of NGM621 in Participants With Geographic Atrophy
NCT ID: NCT04465955
Last Updated: 2025-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
320 participants
INTERVENTIONAL
2020-07-22
2022-08-16
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
QUADRUPLE
Study Groups
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NGM621 Treatment Group A (every 4 weeks)
NGM621 single intravitreal (IVT) injection
NGM621
NGM621 Dose 1
NGM621 Treatment Group C (every 8 weeks)
NGM621 single IVT injection
NGM621
NGM621 Dose 2
Sham Group B (every 4 weeks)
Sham single IVT injection
Sham Comparator
Sham Comparator
Sham Group D (every 8 weeks)
Sham single IVT injection
Sham Comparator
Sham Comparator
Interventions
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NGM621
NGM621 Dose 1
NGM621
NGM621 Dose 2
Sham Comparator
Sham Comparator
Eligibility Criteria
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Inclusion Criteria
* Standard luminance BCVA score of 34 letters or better using ETDRS charts at the starting distance of 4 meters (approximately 20/200 Snellen equivalent or better) in study eye
* Clinical diagnosis of GA secondary to AMD:
1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm² (0.5 DA), with the overall area of GA ≥ 2.5 and ≤ 17.5 mm²
3. Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye
Exclusion Criteria
* GA secondary to a condition other than AMD in either eye (e.g., monogenetic macular dystrophies like Stargardt disease, cone rod dystrophy, or toxic maculopathies)
* Any history of or active choroidal neovascularization (CNV)
Both Eyes
* Any history of or active bacterial, viral, fungal, or parasitic infection in either eye in the 3 months prior to randomization
55 Years
ALL
No
Sponsors
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NGM Biopharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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NGM Study Director
Role: STUDY_DIRECTOR
NGM Biopharmaceuticals
Locations
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Associated Retina Consultants
Phoenix, Arizona, United States
California Retina Consultants
Bakersfield, California, United States
Retina Vitreous Associates
Beverly Hills, California, United States
Retinal Diagnostic Center
Campbell, California, United States
The Retina Partners
Encino, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
Loma Linda University Health
Loma Linda, California, United States
University of California Los Angeles
Los Angeles, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
Retina Institute of California
Palm Desert, California, United States
California Eye Specialists
Pasadena, California, United States
Retina Consultants San Diego
Poway, California, United States
Retinal Consultants Medical Group Inc
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Orange County Retina Medical Group
Santa Ana, California, United States
California Retina Consultants
Santa Barbara, California, United States
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado, United States
Colorado Retina Associates PC
Golden, Colorado, United States
New England Retina Associates PC
Waterford, Connecticut, United States
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States
University of Miami
Coral Gables, Florida, United States
Specialty Retina Center (Coral Springs)
Coral Springs, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Retina Specialty Institute
Pensacola, Florida, United States
Southern Vitreoretinal Associates
Tallahassee, Florida, United States
Retina Vitreous Associates of Florida
Tampa, Florida, United States
Georgia Retina PC
Marietta, Georgia, United States
Gailey Eye Clinic - Bloomington
Bloomington, Illinois, United States
University of Illinois
Chicago, Illinois, United States
University Retina and Macula Associates, PC
Lemont, Illinois, United States
Raj K. Maturi, MD, PC
Indianapolis, Indiana, United States
Retina Associates, PA
Shawnee Mission, Kansas, United States
Thompson Sjaarda, PA
Baltimore, Maryland, United States
Elman Retina Group PA
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Associated Retina Consultants PC
Royal Oak, Michigan, United States
Associated Retina Consultants PC
Traverse City, Michigan, United States
Vitreoretinal Surgery PA
Minneapolis, Minnesota, United States
Deep Blue Retina Clinical Research
Southaven, Mississippi, United States
Sierra Eye Associates
Reno, Nevada, United States
Long Island Vitreoretinal Consultants
Great Neck, New York, United States
Vitreous Retina Macula Consultants of NY
New York, New York, United States
Albany Troy Cataract & Laser Associates
Troy, New York, United States
Western Carolina Retinal Associates
Asheville, North Carolina, United States
Southeast Clinical Research
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Sterling Research Group, Ltd.
Cincinnati, Ohio, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Cascade Medical Research Institute
Springfield, Oregon, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Retinovitreous Associates
Philadelphia, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Southeastern Retina Associates
Knoxville, Tennessee, United States
Tennessee Retina
Nashville, Tennessee, United States
Texas Retina Associates
Arlington, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Texas Retina Associates-Plano
Dallas, Texas, United States
Retina Consultants of Houston
Houston, Texas, United States
Retina Consultants of Houston
The Woodlands, Texas, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Countries
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References
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Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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621-GA-201
Identifier Type: -
Identifier Source: org_study_id
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