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

A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study to Assess Safety, Tolerability, and Efficacy of Intravitreal Injections of FHTR2163 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GALLEGO)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 372
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Retina and Vitreous Consultants
    • Tucson, Arizona, United States, 85704
      • Retina Associates Southwest PC
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Encino, California, United States, 91436
      • The Retina Partners
    • Fullerton, California, United States, 92835-3424
      • Retina Consultants of Orange County
    • Los Angeles, California, United States, 90095-7000
      • Jules Stein Eye Institute/ UCLA
    • 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, 94107
      • W Coast Retina Med Group Inc
    • 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
    • Oak Forest, Illinois, United States, 60452
      • University Retina and Macula Associates, PC
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Wolfe Eye Clinic
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Vitreo Retinal Consultants
  • Maine
    • Portland, Maine, United States, 04101
      • Maine Eye Center
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital.
    • Chevy Chase, Maryland, United States, 20815
      • Retina Group of Washington
    • Hagerstown, Maryland, United States, 21740-5940
      • Cumberland Valley Retina Consultants
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mass Eye and Ear Infirmary
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Vitreo-Retinal Associates
    • Royal Oak, Michigan, United States, 48073
      • Associated Retinal Consultants PC
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
  • 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
    • Bloomfield, New Jersey, United States, 07003
      • Envision Ocular, LLC
    • Cherry Hill, New Jersey, United States, 08034
      • Mid Atlantic Retina
    • Teaneck, New Jersey, United States, 07666
      • Retina Associates of NJ
    • Toms River, New Jersey, United States, 08755
      • Retina Vitreous Center, PA
  • New York
    • Hauppauge, New York, United States, 11788
      • Long Is. Vitreoretinal Consult
    • Oceanside, New York, United States, 11572
      • Ophthalmic Consultants of Long Island
    • Rochester, New York, United States, 14620
      • Retina Associates of Western New York
    • Slingerlands, New York, United States, 12159
      • The Retina Consultants
  • 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, 44122
      • Retina Assoc of Cleveland Inc
    • Cleveland, Ohio, United States, 44195-0001
      • Cleveland Clinic Foundation; Cole Eye Institute
    • Columbus, Ohio, United States, 43212-3153
      • Ohio State University
    • Middleburg Heights, Ohio, United States, 44130
      • Retina Associates of Cleveland - Middleburg Heights Location
    • Youngstown, Ohio, United States, 44505
      • Retina Associates of Cleveland - Youngstown Location
  • 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
    • Abilene, Texas, United States, 79606
      • Retina Res Institute of 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
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
    • The Woodlands, Texas, United States, 77384-4167
      • Retina Consultants of Texas
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Rocky Mountain Retina
  • 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:

• 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.

Exclusion Criteria:

Ocular Exclusion Criteria, Study Eye:

• 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.

Ocular Exclusion Criteria, Both Eyes:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Galegenimab Q4W; 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; Intravitreal (ITV) injections of galegenimab; Other Names: FHTR2163, RG6147
Sham Comparator: Sham Control Q4W; 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; Sham control
Experimental: Galegenimab Q8W; 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; Intravitreal (ITV) injections of galegenimab; Other Names: FHTR2163, RG6147
Sham Comparator: Sham Control Q8W; 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; Sham control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Ocular Adverse Events in the Study Eye	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 to Week 76
Percentage of Participants With Ocular Adverse Events in the Fellow Eye	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 to Week 76
Percentage of Participants With Systemic 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. Non-ocular AEs were the systemic events.	From baseline to Week 76
Percentage of Participants With Serious Adverse Events (SAEs)	SAEs are defined as fatal, life threatening, requires or prolongs patient hospitalization, results in persistent or significant disability/incapacity, or is a significant medical event in the investigator's judgement.	From baseline to Week 76
Percentage of Participants With Adverse Events of Special Interest (AESIs)	AESIs include 1.) cases of potential drug-induced liver injury that include an elevated alanine transaminase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law 2.) Suspected transmission of an infectious agent by galegenimab 3.) AEs resulting from medication error 4.) Sight-threatening AEs of the following criteria: It causes a decrease of >= 30 letters in visual acuity (VA) score, compared with the most recent prior VA assessment, that lasts more than 1 hour and is attributable to galegenimab; it requires surgical intervention to prevent permanent loss of sight; associated with severe (Grade 4+) intraocular inflammation (IOI) and/or IOI-associated retinal vasculitis; in the opinion of the investigator, it may require medical intervention to prevent permanent loss of sight.	From baseline to Week 76
Percentage of Participants With Adverse Events Leading to Study Discontinuation	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. Non-ocular AEs were the systemic events.	From baseline to Week 76
Mean Change in Best Corrected Visual Acuity (BCVA) Score From Baseline to Week 72 as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart Under Low-luminance Conditions	BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m) under low-luminance conditions. A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity.	Baseline, Week 72
Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart	BCVA score was based on the number of letters read correctly on the ETDRS visual acuity chart assessed at a starting distance of 4 meters (m). A decrease in the VA score indicates a worsening in visual acuity. BCVA score testing was performed prior to dilating the eyes. BCVA score ranges from 0 to 100 letters in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A negative change from baseline indicates a decrease in the visual acuity.	Baseline, Week 72

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): October 27, 2022
• Study Completion (Actual): October 27, 2022

Study Registration Dates

• First Submitted: May 31, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

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: GR40973

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).

Drug and device information, study documents

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