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Macular Degeneration, Age-RelatedPhase 2NCT04607148

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

A Phase 2 study testing Galegenimab in people with Macular Degeneration, Age-Related and Geographic Atrophy, run by Genentech, Inc. at 48 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

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… 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?
No, everyone receives an active treatment
How many people
144 participants
Where
48 sitesUnited States
Study dates
16 Nov 2020to 14 Nov 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

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

48 sites in 1 country.

48 sites in 1 country

United States48 sites

  • 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

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Charlotte Eye Ear Nose and Throat Associates PA

    Charlotte, North Carolina, 28210

  • Southeastern Retina Associates Chattanooga

    Chattanooga, Tennessee, 37421

  • Midwest Vision Research Foundation

    Chesterfield, Missouri, 63017

  • Illinois Eye and Ear Infirmary

    Chicago, Illinois, 60612

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Cleveland Clinic Foundation; Cole Eye Institute

    Cleveland, Ohio, 44195-0001

  • Retina Consultants of Southern Colorado PC

    Colorado Springs, Colorado, 80909

  • Retina Foundation of the Southwest

    Dallas, Texas, 75231

  • Rand Eye

    Deerfield Beach, Florida, 33064

  • Southwest Retina Consultants

    Durango, Colorado, 81303

  • 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

  • Colorado Retina Associates, PC

    Lakewood, Colorado, 80228

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Georgia Retina PC

    Marietta, Georgia, 30060-1137

  • Florida Eye Associates - Melbourne 2nd Office

    Melbourne, Florida, 32901

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Mid Atlantic Retina - Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Retina Consultants, San Diego

    Poway, California, 92064

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Associated Retinal Consultants PC

    Royal Oak, Michigan, 48073

  • Retinal Consultants Med Group

    Sacramento, California, 95825

  • West Coast Retina

    San Francisco, California, 94109-5520

  • California Retina Consultants

    Santa Barbara, California, 93103

  • California Retina Consultants - Santa Maria

    Santa Maria, California, 93454

  • 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 Consultants of Texas

    The Woodlands, Texas, 77384-4167

  • NJ Retina Teaneck Clinic

    Toms River, New Jersey, 08755

  • NJ Retina-Toms River

    Toms River, New Jersey, 08755

  • 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

Other trials in United States

About this study

Official title: 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).

Being tested
Galegenimab
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

    Intravitreal (ITV) injections of galegenimab

Study groups in NCT04607148
Study groupRoleWhat they receive
Galegenimab 20 mg Q4WExperimentalParticipants will receive 20 milligrams (mg) galegenimab via ITV injection every 4 weeks (Q4W).
Receives: Drug: Galegenimab
Galegenimab 20 mg Q8WExperimentalParticipants will receive 20 mg galegenimab via ITV injection every 8 weeks (Q8W).
Receives: Drug: Galegenimab
Galegenimab 10 mg Q4WExperimentalParticipants will receive 10 mg galegenimab via ITV injection Q4W.
Receives: Drug: Galegenimab
Galegenimab 10 mg Q8WExperimentalParticipants will receive 10 mg galegenimab via ITV injection Q8W.
Receives: Drug: Galegenimab

What is being measured

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

  1. 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.

    Measured: From baseline up to Week 104

  2. 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.

    Measured: From Baseline up to Week 104

Timeline

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

  1. First posted29 Oct 2020
  2. Study start16 Nov 2020
  3. Primary completion14 Nov 2022
  4. Study completion14 Nov 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
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
144 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04607148
Sponsor's protocol ID
GR42558
Status last verified
Oct 2023
First submitted
22 Oct 2020
Last updated
16 Oct 2023
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).

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 48 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 5 inclusion and 12 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 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. 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 16 Oct 2023). 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?

Percentage of Participants With Ocular Adverse Events (time frame: From baseline up to Week 104). The study lists 2 primary outcomes in all. 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 NCT04607148.

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 16 Oct 2023.

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