A Study Assessing the Safety, Tolerability, and Efficacy of RO7171009 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)
- Age-Related Macular Degeneration
- United States
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of 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 NCT03972709 (GR42558) and receive open-label FHTR2163 injections.
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)
- 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.
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.
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