A Study of NGM621 in Participants With Geographic Atrophy

NCT04465955 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 621-GA-201
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 65

Brief 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.

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (2)

• The Rate of Change From Baseline in Geographic Atrophy (GA) Lesion Area

  The rate of change from baseline in GA lesion area was measured by a non-invasive imaging technique called fundus autofluorescence (FAF) over the 52 weeks of treatment. FAF refers to the spontaneous emission of light by certain substances within the eye when exposed to a specific wavelength of light and involves quantifying the area and progression of atrophic lesions. The minimal GA lesion area is zero, the maximal GA lesion area is unknown. The higher the GA lesion area, the worse the visual outcome.

  Baseline to Week 52

• Number of Participants With Ocular Treatment-emergent Adverse Events in the Study Eye

  A treatment-emergent adverse event (TEAE) was an adverse event (AE) that occurred during or after the first dose of study treatment.

  Baseline to end of study (Week 56)

Secondary Outcomes (12)

• The Change From Baseline in Geographic Atrophy (GA) Lesion Area

  Baseline up to Week 52

• The Rate of Change From Baseline in the Square Root of Geographic Atropy (GA) Lesion Area

  Baseline up to Week 52

• The Change From Baseline in Best Corrected Visual Acuity Score

  Baseline up to Week 52

• The Change From Baseline in Low Luminance Visual Acuity Score

  Baseline up to Week 52

• The Change From Baseline in Low Luminance Deficit Score

  Baseline up to Week 52

Study Arms (4)

NGM621 Treatment Group A (every 4 weeks)

EXPERIMENTAL

NGM621 single intravitreal (IVT) injection

Biological: NGM621

NGM621 Treatment Group C (every 8 weeks)

EXPERIMENTAL

NGM621 single IVT injection

Biological: NGM621

Sham Group B (every 4 weeks)

SHAM COMPARATOR

Sham single IVT injection

Other: Sham Comparator

Sham Group D (every 8 weeks)

SHAM COMPARATOR

Sham single IVT injection

Other: Sham Comparator

Interventions

NGM621 BIOLOGICAL

NGM621 Dose 1

NGM621 Treatment Group A (every 4 weeks)

Sham Comparator OTHER

Sham Comparator

Sham Group B (every 4 weeks); Sham Group D (every 8 weeks)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Total GA area must be ≥ 2.5 and ≤ 17.5 mm²
• 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
• Well demarcated GA with no anatomical evidence of current or prior CNV in the study eye

You may not qualify if:

• 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

Sponsors & Collaborators

• NGM Biopharmaceuticals, Inc: lead

Study Sites (65)

Associated Retina Consultants

Phoenix, Arizona, 85020, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina Vitreous Associates

Beverly Hills, California, 90211, United States

Location

Retinal Diagnostic Center

Campbell, California, 95008, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Retina Institute of California

Palm Desert, California, 92260, United States

Location

California Eye Specialists

Pasadena, California, 91107, United States

Location

Retina Consultants San Diego

Poway, California, 92064, United States

Location

Retinal Consultants Medical Group Inc

Sacramento, California, 95841, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Orange County Retina Medical Group

Santa Ana, California, 92705, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Retina Consultants of Southern Colorado PC

Colorado Springs, Colorado, 80909, United States

Location

Colorado Retina Associates PC

Golden, Colorado, 80401, United States

Location

New England Retina Associates PC

Waterford, Connecticut, 06385, United States

Location

Florida Eye Microsurgical Institute

Boynton Beach, Florida, 33426, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

Specialty Retina Center (Coral Springs)

Coral Springs, Florida, 33067, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Southern Vitreoretinal Associates

Tallahassee, Florida, 32308, United States

Location

Retina Vitreous Associates of Florida

Tampa, Florida, 33607, United States

Location

Georgia Retina PC

Marietta, Georgia, 30060, United States

Location

Gailey Eye Clinic - Bloomington

Bloomington, Illinois, 61704, United States

Location

University of Illinois

Chicago, Illinois, 60612, United States

Location

University Retina and Macula Associates, PC

Lemont, Illinois, 60439, United States

Location

Raj K. Maturi, MD, PC

Indianapolis, Indiana, 46290, United States

Location

Retina Associates, PA

Shawnee Mission, Kansas, 66204, United States

Location

Thompson Sjaarda, PA

Baltimore, Maryland, 21204, United States

Location

Elman Retina Group PA

Baltimore, Maryland, 21237, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Associated Retina Consultants PC

Royal Oak, Michigan, 48073, United States

Location

Associated Retina Consultants PC

Traverse City, Michigan, 49686, United States

Location

Vitreoretinal Surgery PA

Minneapolis, Minnesota, 55435, United States

Location

Deep Blue Retina Clinical Research

Southaven, Mississippi, 38671, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Long Island Vitreoretinal Consultants

Great Neck, New York, 11021, United States

Location

Vitreous Retina Macula Consultants of NY

New York, New York, 10022, United States

Location

Albany Troy Cataract & Laser Associates

Troy, New York, 12180, United States

Location

Western Carolina Retinal Associates

Asheville, North Carolina, 18803, United States

Location

Southeast Clinical Research

Charlotte, North Carolina, 28210, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45219, United States

Location

Retina Associates of Cleveland

Cleveland, Ohio, 44122, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Cascade Medical Research Institute

Springfield, Oregon, 97477, United States

Location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location

Retinovitreous Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Southeastern Retina Associates

Knoxville, Tennessee, 37922, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Texas Retina Associates-Plano

Dallas, Texas, 75231, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• 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.

  PMID: 37314061 DERIVED

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: VP, Clinical Operations
• Organization: NGM Biopharmaceuticals

ngm282@ngmbio.com

(650)243-5555

Study Officials

• NGM Study Director

  NGM Biopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 10, 2020
• Study Start: July 22, 2020
• Primary Completion: August 16, 2022
• Study Completion: August 16, 2022
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (65)