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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04465955
Other study ID # 621-GA-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 22, 2020
Est. completion date August 16, 2022

Study information

Verified date June 2023
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-center evaluation of NGM621 in a randomized, double-masked, sham-controlled study in participants with Geographic Atrophy secondary to Age-related Macular Degeneration.


Recruitment information / eligibility

Status Completed
Enrollment 320
Est. completion date August 16, 2022
Est. primary completion date August 16, 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria: - Male or female (non-pregnant, non-lactating) subjects = 55 years - 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: Study Eye - 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
NGM621
NGM621 Dose 1
NGM621
NGM621 Dose 2
Other:
Sham Comparator
Sham Comparator

Locations

Country Name City State
United States Texas Retina Associates Arlington Texas
United States Western Carolina Retinal Associates Asheville North Carolina
United States California Retina Consultants Bakersfield California
United States Elman Retina Group PA Baltimore Maryland
United States Thompson Sjaarda, PA Baltimore Maryland
United States Retina Vitreous Associates Beverly Hills California
United States Gailey Eye Clinic - Bloomington Bloomington Illinois
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States Florida Eye Microsurgical Institute Boynton Beach Florida
United States Retinal Diagnostic Center Campbell California
United States Southeast Clinical Research Charlotte North Carolina
United States University of Virginia Charlottesville Virginia
United States University of Illinois Chicago Illinois
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 Retina Consultants of Southern Colorado PC Colorado Springs Colorado
United States University of Miami Coral Gables Florida
United States Specialty Retina Center (Coral Springs) Coral Springs Florida
United States Retina Foundation of the Southwest Dallas Texas
United States Texas Retina Associates-Plano Dallas Texas
United States Duke University Durham North Carolina
United States The Retina Partners Encino California
United States Retina Group of Florida Fort Lauderdale Florida
United States National Ophthalmic Research Institute Fort Myers Florida
United States Retina Consultants of Orange County Fullerton California
United States Colorado Retina Associates PC Golden Colorado
United States Long Island Vitreoretinal Consultants Great Neck New York
United States Retina Consultants of Houston Houston Texas
United States Raj K. Maturi, MD, PC Indianapolis Indiana
United States Eye Care Specialists Kingston Pennsylvania
United States Southeastern Retina Associates Knoxville Tennessee
United States University Retina and Macula Associates, PC Lemont Illinois
United States Loma Linda University Health Loma Linda California
United States University of California Los Angeles Los Angeles California
United States Georgia Retina PC Marietta Georgia
United States Florida Eye Associates Melbourne Florida
United States Vitreoretinal Surgery PA Minneapolis Minnesota
United States Northern California Retina Vitreous Associates Mountain View California
United States Tennessee Retina Nashville Tennessee
United States Vitreous Retina Macula Consultants of NY New York New York
United States Retina Institute of California Palm Desert California
United States California Eye Specialists Pasadena California
United States Retina Specialty Institute Pensacola Florida
United States Retinovitreous Associates Philadelphia Pennsylvania
United States Associated Retina Consultants Phoenix Arizona
United States Retina Consultants San Diego Poway California
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Sierra Eye Associates Reno Nevada
United States Associated Retina Consultants PC Royal Oak Michigan
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 Associates, PA Shawnee Mission Kansas
United States Deep Blue Retina Clinical Research Southaven Mississippi
United States Spokane Eye Clinical Research Spokane Washington
United States Cascade Medical Research Institute Springfield Oregon
United States Southern Vitreoretinal Associates Tallahassee Florida
United States Retina Vitreous Associates of Florida Tampa Florida
United States Retina Consultants of Houston The Woodlands Texas
United States Associated Retina Consultants PC Traverse City Michigan
United States Albany Troy Cataract & Laser Associates Troy New York
United States New England Retina Associates PC Waterford Connecticut
United States Strategic Clinical Research Group, LLC Willow Park Texas

Sponsors (1)

Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of change in GA lesion area as measured by fundus autofluorescence (FAF) over the 52 weeks of treatment The primary efficacy endpoint 52 Weeks
Primary The incidence and severity of ocular and systemic adverse events from treatment with NGM621 administered every 4 or 8 weeks compared to Sham The primary safety endpoints 52 Weeks
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