A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

NCT03972709 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: GR40973
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 72

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.

Conditions

Macular Degeneration, Age-Related; Geographic Atrophy

Outcome Measures

Primary Outcomes (1)

• Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)

  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).

  Baseline, Week 72

Secondary Outcomes (8)

• Percentage of Participants With Ocular Adverse Events in the Study Eye

  From baseline to Week 76

• Percentage of Participants With Ocular Adverse Events in the Fellow Eye

  From baseline to Week 76

• Percentage of Participants With Systemic Adverse Events

  From baseline to Week 76

• Percentage of Participants With Serious Adverse Events (SAEs)

  From baseline to Week 76

• Percentage of Participants With Adverse Events of Special Interest (AESIs)

  From baseline to Week 76

Study Arms (4)

Galegenimab Q4W

EXPERIMENTAL

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.

Drug: Galegenimab

Sham Control Q4W

SHAM COMPARATOR

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.

Drug: Sham Control

Galegenimab Q8W

EXPERIMENTAL

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.

Drug: Galegenimab

Sham Control Q8W

SHAM COMPARATOR

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.

Drug: Sham Control

Interventions

Galegenimab DRUG

Intravitreal (ITV) injections of galegenimab

Also known as: FHTR2163, RG6147

Galegenimab Q4W; Galegenimab Q8W

Sham Control DRUG

Sham control

Sham Control Q4W; Sham Control Q8W

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (72)

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, 85016, United States

Location

Retina Associates Southwest PC

Tucson, Arizona, 85704, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835-3424, United States

Location

Jules Stein Eye Institute/ UCLA

Los Angeles, California, 90095-7000, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Retina Consultants, San Diego

Poway, California, 92064, United States

Location

Retinal Consultants Med Group

Sacramento, California, 95825, United States

Location

W Coast Retina Med Group Inc

San Francisco, California, 94107, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

California Retina Consultants - Santa Maria

Santa Maria, California, 93454, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Retina Consultants of Southern Colorado PC

Colorado Springs, Colorado, 80909, United States

Location

Southwest Retina Consultants

Durango, Colorado, 81303, United States

Location

Colorado Retina Associates, PC

Lakewood, Colorado, 80228, United States

Location

Rand Eye

Deerfield Beach, Florida, 33064, United States

Location

Florida Eye Associates - Melbourne 2nd Office

Melbourne, Florida, 32901, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Retina Vitreous Assoc of FL

St. Petersburg, Florida, 33711, United States

Location

Southern Vitreoretinal Associates

Tallahassee, Florida, 32308, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Georgia Retina PC

Marietta, Georgia, 30060-1137, United States

Location

Illinois Eye and Ear Infirmary

Chicago, Illinois, 60612, United States

Location

University Retina and Macula Associates, PC

Oak Forest, Illinois, 60452, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Vitreo Retinal Consultants

Wichita, Kansas, 67214, United States

Location

Maine Eye Center

Portland, Maine, 04101, United States

Location

The Retina Care Center

Baltimore, Maryland, 21209, United States

Location

Johns Hopkins Hospital.

Baltimore, Maryland, 21287, United States

Location

Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740-5940, United States

Location

Mass Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

Vitreo-Retinal Associates

Grand Rapids, Michigan, 49546, United States

Location

Associated Retinal Consultants PC

Royal Oak, Michigan, 48073, United States

Location

VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

Edina, Minnesota, 55435, United States

Location

Midwest Vision Research Foundation

Chesterfield, Missouri, 63017, United States

Location

The Retina Institute

St Louis, Missouri, 63128, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Envision Ocular, LLC

Bloomfield, New Jersey, 07003, United States

Location

Mid Atlantic Retina

Cherry Hill, New Jersey, 08034, United States

Location

Retina Associates of NJ

Teaneck, New Jersey, 07666, United States

Location

Retina Vitreous Center, PA

Toms River, New Jersey, 08755, United States

Location

Long Is. Vitreoretinal Consult

Hauppauge, New York, 11788, United States

Location

Ophthalmic Consultants of Long Island

Oceanside, New York, 11572, United States

Location

Retina Associates of Western New York

Rochester, New York, 14620, United States

Location

The Retina Consultants

Slingerlands, New York, 12159, United States

Location

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803, United States

Location

Charlotte Eye Ear Nose and Throat Associates PA

Charlotte, North Carolina, 28210, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Retina Assoc of Cleveland Inc

Cleveland, Ohio, 44122, United States

Location

Cleveland Clinic Foundation; Cole Eye Institute

Cleveland, Ohio, 44195-0001, United States

Location

Ohio State University

Columbus, Ohio, 43212-3153, United States

Location

Retina Associates of Cleveland - Middleburg Heights Location

Middleburg Heights, Ohio, 44130, United States

Location

Retina Associates of Cleveland - Youngstown Location

Youngstown, Ohio, 44505, United States

Location

Casey Eye Institute

Portland, Oregon, 97239, United States

Location

Mid Atlantic Retina - Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Southeastern Retina Associates Chattanooga

Chattanooga, Tennessee, 37421, United States

Location

Charles Retina Institute

Germantown, Tennessee, 38138, United States

Location

Tennessee Retina PC

Nashville, Tennessee, 37203, United States

Location

Retina Res Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Austin, Texas, 78705-1169, United States

Location

Austin Clinical Research LLC

Austin, Texas, 78750, United States

Location

Retina Foundation of the Southwest

Dallas, Texas, 75231, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384-4167, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Rocky Mountain Retina

Salt Lake City, Utah, 84107, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 4, 2019
• Study Start: June 3, 2019
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

US (72)