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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Macular Degeneration, Age-Related, Geographic Atrophy

Intervention / Treatment
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* Drug: Galegenimab
* Drug: Sham Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galegenimab Q4W<br>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. | Drug: Galegenimab<br>* Intravitreal (ITV) injections of galegenimab<br>* Other names: FHTR2163, RG6147;|
| Sham Comparator: Sham Control Q4W<br>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. | Drug: Sham Control<br>* Sham control<br>|
| Experimental: Galegenimab Q8W<br>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. | Drug: Galegenimab<br>* Intravitreal (ITV) injections of galegenimab<br>* Other names: FHTR2163, RG6147;|
| Sham Comparator: Sham Control Q8W<br>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. | Drug: Sham Control<br>* Sham control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in GA Area from Baseline to Week 72 as Measured by Fundus Autofluorescence (FAF) |  | Baseline, Week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Ocular Adverse Events |  | From baseline to Week 76 | 
| Percentage of Participants With Systemic Adverse Events |  | From baseline to Week 76 | 
| Percentage of Participants With Serious Adverse Events (SAEs) |  | From baseline to Week 76 | 
| Percentage of Participants With Adverse Events of Special Interest (AESIs) |  | From baseline to Week 76 | 
| Percentage of Participants With Adverse Events Leading to Study Discontinuation |  | From baseline to Week 76 | 
| 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 |  | Baseline, Week 72 | 
| Mean Change in BCVA Score from Baseline to Week 72 as Assessed by ETDRS Chart |  | Baseline, Week 72 |