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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
429
5 mg tablet taken orally once a day
Placebo tablets for tinlarebant 5 mg prepared similarly.
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size
Time frame: From baseline to Month 24]
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale
Time frame: From baseline to Month 24
To measure changes in the area and size of the inner/outer segment junction of photoreceptors by spectral domain optical coherence tomography (SD-OCT)
Time frame: From baseline to Month 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Belite Study Site
Phoenix, Arizona, United States
Belite Study Site
Arcadia, California, United States
Belite Study Site
Beverly Hills, California, United States
Belite Study Site
Huntington Beach, California, United States
Belite Study Site
Los Angeles, California, United States
Belite Study Site
Palo Alto, California, United States
Belite Study Site
San Diego, California, United States
Belite Study Site
Lakeland, Florida, United States
Belite Study Site
Hagerstown, Maryland, United States
Belite Study Site
Saint Louis Park, Minnesota, United States
...and 39 more locations