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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

Summary

This trial tests the safety and effectiveness of eye injections of galegenimab for people with vision loss due to age-related macular degeneration. The injections are given periodically to see if they can help slow down the disease.

Eligible Conditions
  • Age-Related Macular Degeneration

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change in Geographic Atrophy (GA) Area From Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF)
Secondary study objectives
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

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.

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Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,550 Previous Clinical Trials
567,992 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,212 Previous Clinical Trials
892,044 Total Patients Enrolled
~60 spots leftby Sep 2025
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