Phase three, multicentre, randomized, double-masked, placebo-controlled study of Tinlarebant to explore safety and efficacy in the treatment of Geographic Atrophy (the PHOENIX Study)
This is a global clinical research study to evaluate the safety and efficacy of an oral once-a-day Tinlarebant tablet for the treatment of geographic atrophy (GA), sponsored by Belite Bio, Inc. Patients who qualify to participate will be randomized to receive either the Tinlarebant or placebo tablet for a period of 24 months. The drug aims to prevent the accumulation of vitamin A- based toxins (bisretinoids), reducing the amount of vitamin A delivered to the eye that contributes to disease progression in Geographic Atrophy patients.
To be considered for the study, patients need to meet specific eligibility criteria, including but not limited to:
- Patients aged 60 to 85 years
- Confirmed diagnosis of GA with atrophic lesions 1 mm2 to 10 mm2 in one or both eyes (FAF/OPTOS images)
- Lesions with foveal involvement: BCVA 20/80 or better (≥ 54 ETDRS letters)
- Lesions without foveal involvement: BCVA 20/100 or better (≥ 49 ETDRS letters) No presence of diabetic macular edema or macular disease in either eye.
Registry number: NCT05949593
To enquire further about this study, please contact the Lions Vision Trials team on (08) 9381 0777, or email lionsvisiontrials@lei.org.au.
