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)
Sponsor: Genentech, Inc.
Principal Investigator: Barbara Blodi, MD
Study Coordinator: Kris Dietzman
To evaluate the safety, tolerability, and efficacy of intravitreal injections of RG6147 in participants with geographic atrophy secondary to age-related macular degeneration.
Subjects will receive RG6147 or sham-control every 4 weeks or every 8 weeks. After completing the study’s last visit (Week 76), eligible participants will have the option to enroll in an open-label extension study (GR42558) and receive open-label RG6147 injections.
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);
Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye
GallegOLE is an open-label extension study and participants must have completed the parent study (NCT03972709/GR40973) through the Week 76 visit without early treatment discontinuation
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.