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

NCT04607148 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: GR42558
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 48

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of intravitreal (ITV) injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who completed the parent study (NCT03972709/GR40973).

Conditions

Macular Degeneration, Age-Related; Geographic Atrophy

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Ocular Adverse Events

  An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.

  From baseline up to Week 104

• Percentage of Participants With Systemic (Non-Ocular) Adverse Events

  An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test.

  From Baseline up to Week 104

Study Arms (4)

Galegenimab 20 mg Q4W

EXPERIMENTAL

Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).

Drug: Galegenimab

Galegenimab 20 mg Q8W

EXPERIMENTAL

Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).

Drug: Galegenimab

Galegenimab 10 mg Q4W

EXPERIMENTAL

Participants will receive 10 mg galegenimab via ITV injection Q4W.

Drug: Galegenimab

Galegenimab 10 mg Q8W

EXPERIMENTAL

Participants will receive 10 mg galegenimab via ITV injection Q8W.

Drug: Galegenimab

Interventions

Galegenimab DRUG

Intravitreal (ITV) injections of galegenimab

Also known as: FHTR2163

Galegenimab 10 mg Q4W; Galegenimab 10 mg Q8W; Galegenimab 20 mg Q4W; Galegenimab 20 mg Q8W

Eligibility Criteria

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

You may qualify if:

• Completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation
• Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit acceptable fundus imaging.
• \- The non-study eye must have a BCVA letter score of ≥44 letters (Snellen equivalent of 20/125 or better) if the study eye BCVA letter score is ≥69 letters (Snellen equivalent of 20/40 or better) on visit Day 1 OLE/Week 76 of parent study.

You may not qualify if:

• Active uveitis and/or vitritis (grade trace or above) in either eye
• Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
• Active or history of choroidal neovascularization (CNV) in study eye that requires anti-vascular endothelial growth factor (anti-VEGF) treatment
• Active or recent history (i.e., since enrollment in parent study) of optic neuritis in either eye
• Retinal pigment epithelium (RPE) tear that involves the macula in either eye
• Moderate or severe non-proliferative diabetic retinopathy in either eye
• Proliferative diabetic retinopathy in either eye
• Central serous retinopathy in either eye
• Recent history of recurrent infectious or inflammatory ocular disease in either eye
• Recent history of idiopathic or autoimmune-associated uveitis in either eye
• Any concurrent ocular or intraocular condition in the study eye that contraindicates the use of an investigational drug or may affect interpretation of the study results or may render the participant at high risk for treatment complications.

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (48)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835-3424, 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

West Coast Retina

San Francisco, California, 94109-5520, 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

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Vitreo Retinal Consultants

Wichita, Kansas, 67214, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Vitreo-Retinal Associates

Grand Rapids, Michigan, 49546, United States

Location

Associated Retinal Consultants PC

Royal Oak, Michigan, 48073, 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

NJ Retina Teaneck Clinic

Toms River, New Jersey, 08755, United States

Location

NJ Retina-Toms River

Toms River, New Jersey, 08755, United States

Location

Ophthalmic Consultants of Long Island

Oceanside, New York, 11572, 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

Cleveland Clinic Foundation; Cole Eye Institute

Cleveland, Ohio, 44195-0001, 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

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

Retina Consultants of Texas

The Woodlands, Texas, 77384-4167, 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: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study will be masked until database lock of the parent study (NCT03972709/GR40973). After the masked period, the study will follow an open-label design. The Outcome Assessor is masked for BCVA assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: November 16, 2020
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: October 16, 2023
• Results First Posted: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (48)