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Monoclonal Antibodies

Galegenimab Q4W for Age-Related Macular Degeneration (GALLEGO Trial)

Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 76
Awards & highlights

GALLEGO Trial Summary

This trial will study a new drug for age-related macular degeneration given either every 4 weeks or 8 weeks. The goal is to see if it is safe and effective compared to a sham control. Participants will have the option to continue in an extension study after the trial is complete.

Eligible Conditions
  • Age-Related Macular Degeneration

GALLEGO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 76
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 76 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)
Secondary outcome measures
Mean Change in BCVA Score From Baseline to Week 72 as Assessed by ETDRS Chart
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
Percentage of Participants With Adverse Events Leading to Study Discontinuation
+5 more

GALLEGO Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Galegenimab Q8WExperimental Treatment1 Intervention
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.
Group II: Galegenimab Q4WExperimental Treatment1 Intervention
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.
Group III: Sham Control Q4WPlacebo Group1 Intervention
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.
Group IV: Sham Control Q8WPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,539 Previous Clinical Trials
567,317 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many different locations are conducting this trial?

"Currently, there are 76 sites where patients can enroll in this study. The locations of these facilities include Bellaire, Cleveland, Middleburg Heights as well other cities. If you choose to participate in this trial, it is best to select a clinic nearby to avoid having travel as a barrier."

Answered by AI

Are new patients still being accepted into this clinical trial?

"Unfortunately, this particular study is no longer actively recruiting patients. The original posting was on June 3rd, 2019 and the last update was September 13th, 2022. Although this specific trial is not enrolling new participants, there are329 other trials with open recruitment at the moment."

Answered by AI

What is the status of FHTR2163's FDA approval process?

"FHTR2163's safety received a score of 2 because, while there is some clinical data supporting its safety, there is none that suggests it is an effective medication."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
65+
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
2019. "A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03972709.
~64 spots leftby Apr 2025
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