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

Genentech

Status and phase: Terminated; Phase 2

Conditions: Geographic Atrophy; Macular Degeneration, Age-Related

Treatments: Drug: Galegenimab; Drug: Sham Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT03972709

GR40973

Details and patient eligibility

About

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.

Enrollment: 372 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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372 participants in 4 patient groups

Galegenimab Q4W

Experimental group

Description:

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.

Treatment:

Drug: Galegenimab

Sham Control Q4W

Sham Comparator group

Description:

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.

Treatment:

Drug: Sham Control

Galegenimab Q8W

Experimental group

Description:

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.

Treatment:

Drug: Galegenimab

Sham Control Q8W

Sham Comparator group

Description:

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.

Treatment:

Drug: Sham Control