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

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

Macular Degeneration
Age-Related Macular Degeneration

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 76

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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