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

Description

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.

Conditions

Geographic Atrophy

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Study Overview

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Study Details

Study 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.

PHase 3, Multicenter, RandOmized, Double-masked, PlacEbo-CoNtrolled Study of TInlarebant to EXplore Safety and Efficacy in the Treatment of Geographic Atrophy (the PHOENIX Study)

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

Condition
Geographic Atrophy
Intervention / Treatment

-

Contacts and Locations

Phoenix

Belite Study Site, Phoenix, Arizona, United States, 85020

Arcadia

Belite Study Site, Arcadia, California, United States, 91007

Beverly Hills

Belite Study Site, Beverly Hills, California, United States, 90211

Huntington Beach

Belite Study Site, Huntington Beach, California, United States, 92467

Los Angeles

Belite Study Site, Los Angeles, California, United States, 90033

San Diego

Belite Study Site, San Diego, California, United States, 92093

Hagerstown

Belite Study Site, Hagerstown, Maryland, United States, 21740

Westbury

Belite Study Site, Westbury, New York, United States, 11590

Durham

Belite Study Site, Durham, North Carolina, United States, 27710

Wake Forest

Belite Study Site, Wake Forest, North Carolina, United States, 27587

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

60 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Belite Bio, Inc,

Study Record Dates

2027-11-30