A Study Assessing the Safety, Tolerability, and Efficacy of RG6147 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

• Status: Recruiting
• Trial end date: 2024-06-03
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of RG6147 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 NCT03972709 (GR42558) and receive open-label RG6147 injections.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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.