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ACTIVE_NOT_RECRUITINGPHASE3

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

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)

NCT05949593•Belite Bio, Inc

View on ClinicalTrials.gov

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.

Detailed 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

Age

60 - 85 years

Sex

ALL

Healthy Volunteers

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 (49)

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

Key Dates

Start Date

July 27, 2023

Primary Completion Date

June 30, 2027

Completion Date

August 31, 2027

Last Updated

January 7, 2026

Enrollment

429

ESTIMATED participants

Conditions

Geographic Atrophy

Interventions

Tinlarebant

DRUG

Placebo

DRUG

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

NCT06779773

Geographic AtrophyMacular Degeneration

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RECRUITINGPHASE2

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

NCT06990269

Geographic Atrophy Secondary to Age-related Macular Degeneration

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

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