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

A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

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).

Study Overview

• Status: Terminated
• Conditions: Geographic Atrophy; Macular Degeneration, Age-Related
• Intervention / Treatment: Drug: Galegenimab

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
    • Encino, California, United States, 91436
      • The Retina Partners
    • Fullerton, California, United States, 92835-3424
      • Retina Consultants of Orange County
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates
    • Poway, California, United States, 92064
      • Retina Consultants, San Diego
    • Sacramento, California, United States, 95825
      • Retinal Consultants Med Group
    • San Francisco, California, United States, 94109-5520
      • West Coast Retina
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
    • Santa Maria, California, United States, 93454
      • California Retina Consultants - Santa Maria
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Retina Consultants of Southern Colorado PC
    • Durango, Colorado, United States, 81303
      • Southwest Retina Consultants
    • Lakewood, Colorado, United States, 80228
      • Colorado Retina Associates, PC
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates - Melbourne 2nd Office
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Saint Petersburg, Florida, United States, 33711
      • Retina Vitreous Assoc of FL
    • Tallahassee, Florida, United States, 32308
      • Southern Vitreoretinal Associates
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center
    • Marietta, Georgia, United States, 30060-1137
      • Georgia Retina PC
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Illinois Eye and Ear Infirmary
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Vitreo Retinal Consultants
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Vitreo-Retinal Associates
    • Royal Oak, Michigan, United States, 48073
      • Associated Retinal Consultants PC
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Midwest Vision Research Foundation
    • Saint Louis, Missouri, United States, 63128
      • The Retina Institute
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • NJ Retina Teaneck Clinic
    • Toms River, New Jersey, United States, 08755
      • NJ Retina-Toms River
  • New York
    • Oceanside, New York, United States, 11572
      • Ophthalmic Consultants of Long Island
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associate PA
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose and Throat Associates PA
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
    • Cleveland, Ohio, United States, 44195-0001
      • Cleveland Clinic Foundation; Cole Eye Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Casey Eye Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina - Wills Eye Hospital
  • South Carolina
    • West Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Southeastern Retina Associates Chattanooga
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institute
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina PC
  • Texas
    • Austin, Texas, United States, 78750
      • Austin Clinical Research LLC
    • Austin, Texas, United States, 78705-1169
      • Austin Retina Associates
    • Dallas, Texas, United States, 75231
      • Retina Foundation of the Southwest
    • The Woodlands, Texas, United States, 77384-4167
      • Retina Consultants of Texas
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Ocular Inclusion Criteria: Study Eye - If the study eye best corrected visual acuity (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) on visit Day 1 of the open label extension (OLE)/Week 76 of parent study.

Ocular Inclusion Criteria: Non-Study Eye

- 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.

Exclusion Criteria:

Ocular Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Galegenimab 20 mg Q4W; Participants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).	Drug: Galegenimab; Intravitreal (ITV) injections of galegenimab; Other Names: FHTR2163
Experimental: Galegenimab 20 mg Q8W; Participants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).	Drug: Galegenimab; Intravitreal (ITV) injections of galegenimab; Other Names: FHTR2163
Experimental: Galegenimab 10 mg Q4W; Participants will receive 10 mg galegenimab via ITV injection Q4W.	Drug: Galegenimab; Intravitreal (ITV) injections of galegenimab; Other Names: FHTR2163
Experimental: Galegenimab 10 mg Q8W; Participants will receive 10 mg galegenimab via ITV injection Q8W.	Drug: Galegenimab; Intravitreal (ITV) injections of galegenimab; Other Names: FHTR2163

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Concentration of FHTR2163	Day 1, Weeks 24, 48, 72, 96, 144, unscheduled visit (UV) or early termination (ET) visit (up to Week 148)
Aqueous Humor Concentration of FHTR2163	Day 1, Weeks 24, 48, 72, 96, 144 and UV (up to Week 148)
Percentage of Participants With Anti-Drug Antibodies to FHTR2163	Day 1, Weeks 24, 48, 72, 96, 144, UV or ET visit (up to Week 148)

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2020
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): November 14, 2022

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Macular Degeneration; Geographic Atrophy; Atrophy
• Other Study ID Numbers: GR42558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No