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Macular Degeneration, Age-RelatedPhase 2GALLEGONCT03972709

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

A Phase 2 study testing Galegenimab in people with Macular Degeneration, Age-Related and Geographic Atrophy, run by Genentech, Inc. at 72 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Galegenimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
372 participants
Where
72 sitesUnited States
Study dates
3 Jun 2019to 27 Oct 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

United States72 sites

  • Retina Res Institute of Texas

    Abilene, Texas, 79606

  • Western Carolina Retinal Associate PA

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705-1169

  • Austin Clinical Research LLC

    Austin, Texas, 78750

  • California Retina Consultants

    Bakersfield, California, 93309

  • The Retina Care Center

    Baltimore, Maryland, 21209

  • Johns Hopkins Hospital.

    Baltimore, Maryland, 21287

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Envision Ocular, LLC

    Bloomfield, New Jersey, 07003

  • Mass Eye and Ear Infirmary

    Boston, Massachusetts, 02114

  • Charlotte Eye Ear Nose and Throat Associates PA

    Charlotte, North Carolina, 28210

  • Southeastern Retina Associates Chattanooga

    Chattanooga, Tennessee, 37421

  • Mid Atlantic Retina

    Cherry Hill, New Jersey, 08034

  • Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • Illinois Eye and Ear Infirmary

    Chicago, Illinois, 60612

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Retina Assoc of Cleveland Inc

    Cleveland, Ohio, 44122

  • Cleveland Clinic Foundation; Cole Eye Institute

    Cleveland, Ohio, 44195-0001

  • Retina Consultants of Southern Colorado PC

    Colorado Springs, Colorado, 80909

  • Ohio State University

    Columbus, Ohio, 43212-3153

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • Rand Eye

    Deerfield Beach, Florida, 33064

  • Southwest Retina Consultants

    Durango, Colorado, 81303

  • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

    Edina, Minnesota, 55435

  • The Retina Partners

    Encino, California, 91436

  • Retina Consultants of Orange County

    Fullerton, California, 92835-3424

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Vitreo-Retinal Associates

    Grand Rapids, Michigan, 49546

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740-5940

  • Long Is. Vitreoretinal Consult

    Hauppauge, New York, 11788

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228

  • Jules Stein Eye Institute/ UCLA

    Los Angeles, California, 90095-7000

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Georgia Retina PC

    Marietta, Georgia, 30060-1137

  • Florida Eye Associates - Melbourne 2nd Office

    Melbourne, Florida, 32901

  • Retina Associates of Cleveland - Middleburg Heights Location

    Middleburg Heights, Ohio, 44130

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Arizona Retina and Vitreous Consultants

    Phoenix, Arizona, 85016

  • Maine Eye Center

    Portland, Maine, 04101

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Associates of Western New York

    Rochester, New York, 14620

  • Associated Retinal Consultants PC

    Royal Oak, Michigan, 48073

  • Retinal Consultants Med Group

    Sacramento, California, 95825

  • Rocky Mountain Retina

    Salt Lake City, Utah, 84107

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • W Coast Retina Med Group Inc

    San Francisco, California, 94107

  • California Retina Consultants

    Santa Barbara, California, 93103

  • California Retina Consultants - Santa Maria

    Santa Maria, California, 93454

  • The Retina Consultants

    Slingerlands, New York, 12159

  • Spokane Eye Clinical Research

    Spokane, Washington, 99204

  • The Retina Institute

    St Louis, Missouri, 63128

  • Retina Vitreous Assoc of FL

    St. Petersburg, Florida, 33711

  • Southern Vitreoretinal Associates

    Tallahassee, Florida, 32308

  • Retina Associates of NJ

    Teaneck, New Jersey, 07666

  • Retina Consultants of Texas

    The Woodlands, Texas, 77384-4167

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Retina Vitreous Center, PA

    Toms River, New Jersey, 08755

  • Retina Associates Southwest PC

    Tucson, Arizona, 85704

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Vitreo Retinal Consultants

    Wichita, Kansas, 67214

  • Retina Associates of Cleveland - Youngstown Location

    Youngstown, Ohio, 44505

Other trials in United States

About this study

Official title: 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.

Being tested
Galegenimab, Sham Control
Medical subject headings
Macular Degeneration, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalegenimabDrug

    Also called FHTR2163, RG6147

    Intravitreal (ITV) injections of galegenimab

  • Sham ControlDrug

    Sham control

Study groups in NCT03972709
Study groupRoleWhat they receive
Galegenimab Q4WExperimentalParticipants 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.
Receives: Drug: Galegenimab
Sham Control Q4WSham comparatorParticipants 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.
Receives: Drug: Sham Control
Galegenimab Q8WExperimentalParticipants 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.
Receives: Drug: Galegenimab
Sham Control Q8WSham comparatorParticipants 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.
Receives: Drug: Sham Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, Week 72

Secondary outcomes (8)

  1. 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.

    Measured: From baseline to Week 76

  2. 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.

    Measured: From baseline to Week 76

  3. 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.

    Measured: From baseline to Week 76

  4. 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.

    Measured: From baseline to Week 76

  5. 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.

    Measured: From baseline to Week 76

  6. 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.

    Measured: From baseline to Week 76

  7. 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.

    Measured: Baseline, Week 72

  8. 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.

    Measured: Baseline, Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start3 Jun 2019
  3. Primary completion27 Oct 2022
  4. Study completion27 Oct 2022

Why it stopped: The benefit to risk balance did not support further treatment with galegenimab (FHTR2163).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03972709
Sponsor's protocol ID
GR40973
Acronym
GALLEGO
Status last verified
Mar 2024
First submitted
31 May 2019
Last updated
27 Mar 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Cohen Y, Usdin M, McLeod M, Kikuchi Y, Zhang M, Yang Q, Mesquida M. Deep Learning-Based Quantification of Vitreous Hyperreflective Foci as a Biomarker for Intraocular Inflammation. Ophthalmol Sci. 2026 May 28;6(8):101263. doi: 10.1016/j.xops.2026.101263. eCollection 2026 Aug.

    PubMed 42518791

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Galegenimab in people with Macular Degeneration, Age-Related and Geographic Atrophy, run by Genentech, Inc. at 72 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) (time frame: Baseline, Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03972709, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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