Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy

• Status: Recruiting
• Trial end date: 2027-11-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belite Bio, Inc

Criteria

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