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Active (not recruiting) Phase 3 NCT05949593

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

Phase 3 – large-scale trial before approval
Conditions: Geographic Atrophy

Sponsor: Belite Bio, Inc

trial.available_in: БГ
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.
Who can participate
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
Locations 8
Australia (1)
Belite Study Site
Chatswood , New South Wales
China (1)
Belite Study Site
Beijing , Beijing Municipality
Czech Republic (1)
Belite Study Site
Ostrava
France (1)
Belite Study Site
Dijon
Switzerland (1)
Belite Study Site
Basel
Taiwan (1)
Belite Study Site
Taichung
United Kingdom (1)
Belite Study Site
Great Yarmouth
United States (1)
Belite Study Site
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
60 Years
Maximum age
85 Years
Healthy volunteers
No
Start date
27.07.2023
Completion date
31.08.2027
Registry ID
NCT05949593
Source
anzctr
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