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Evaluating the safety and effectiveness of tinlarebant for 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)

Phase 3 Interventional Belite Bio, Inc · NCT05949593

This study is testing if a new oral medication called tinlarebant can slow down the progression of geographic atrophy and improve vision in people who have this condition.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment429 (estimated)
Ages60 Years to 85 Years
SexAll
SponsorBelite Bio, Inc Industry-sponsored
Locations49 sites (Phoenix, Arizona and 48 other locations)
Trial IDNCT05949593 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a multicenter, double-masked, placebo-controlled study aimed at assessing the safety and efficacy of tinlarebant (LBS-008) in patients diagnosed with geographic atrophy (GA). Participants will be randomly assigned in a 2:1 ratio to receive either the active treatment or a placebo, with the treatment administered orally once daily for 24 months. The study will focus on measuring the impact of tinlarebant on the progression of GA and overall visual function.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with a confirmed diagnosis of geographic atrophy and specific visual acuity requirements.

Not a fit: Patients with diabetic macular edema, advanced diabetic retinopathy, or uncontrolled glaucoma in the study eye may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could slow the progression of geographic atrophy and preserve vision for patients affected by this condition.

How similar studies have performed: Other studies have explored treatments for geographic atrophy, but the specific approach with tinlarebant is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 48 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Geographic AtrophyLBS-008TinlarebantGA
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.