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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05949593

Acronym

PHOENIX

Enrollment

429

Registered

2023-07-18

Start date

2023-07-27

Completion date

2027-08-31

Last updated

2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy

Keywords

LBS-008, Tinlarebant, GA

Brief 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.

Interventions

DRUGTinlarebant

5 mg tablet taken orally once a day

DRUGPlacebo

Placebo tablets for tinlarebant 5 mg prepared similarly.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Eligible subjects will be randomly assigned to begin treatment in 2:1 ratio to receive the study drug (either Tinlarebant 5 mg or matching placebo)

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
To measure the rate of change (growth rate slope) in geographic atrophy (GA) lesion size	From baseline to Month 24]

Secondary

Measure	Time frame
To measure the change in best-corrected visual acuity (BCVA) as assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale	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)	From baseline to Month 24

Countries

Australia, China, Czechia, France, Switzerland, Taiwan, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026