Overview
This Phase 3, multicenter, double-masked, parallel-group, placebo-controlled, randomized, fixed-dose clinical study is designed to evaluate the efficacy and safety of tinlarebant (LBS-008) in subjects diagnosed with GA.
Description
Subjects will be randomized in a 2:1 ratio to receive either tinlarebant or placebo. The study treatment will be administered orally once daily from baseline (Day 1) through the final day of Month 24.
Eligibility
Inclusion Criteria:
- Subjects must have a confirmed diagnosis of GA with atrophic lesions in 1 or both eyes.
- Minimum BCVA is required in the study eye
Exclusion Criteria:
- The presence of diabetic macular edema or macular disease in either eye.
- Diabetic retinopathy more advanced than mild nonproliferative diabetic retinopathy, or any other retinal vascular disease in either eye.
- Uncontrolled diagnosed glaucoma in the study eye