The PHOENIX Study
Research type
Research Study
Full title
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)
IRAS ID
1008687
Contact name
Lisa Liang
Contact email
Sponsor organisation
Belite Bio Inc.
Research summary
Geographic Atrophy (GA) defines the condition whereby progressive degeneration of the macular (the central region of the retina) causes atrophic lesions to form which can ultimately lead to substantial vision loss. GA is an advanced form of dry age-related macular degeneration (AMD). This Phase III study aims to evaluate the rate of change within the atrophic lesion sizes, differences within the retina dimensions, clarity of vision and overall safety of the orally administered investigational product, Tinlarebant. Growth of atrophic lesions relates to loss of photoreceptors (the cell found in the retina capable of converting light into signals that can stimulate biological processes) and subsequent loss of vision. The main outcome is assessed by calculating the annual growth of the atrophic lesion. Lesion size will be measured through fundus autofluorescence photography (illuminating the retina with blue light to make the cells “glow”) during the 24 months the study lasts.
The LBS-008-CT05 phase III, multicentre, double-masked, parallel-group, placebo controlled, fixed-dose clinical study will randomise participants in a 2:1 ratio. 2 out of 3 subjects, the treatment group, will receive 5mg of tinlarebant once daily, whilst 1 out of 3 subjects, the controlled group, receive the placebo once daily. Subjects will receive the treatment for 24 months after they have been randomly assigned the study drug or the placebo. Subjects will have an end-of-study visit 28 days after the last treatment.
Participants selected for this study must be males or females aged from 60 to 85, with diagnosed GA and small GA lesions, with eyesight that has not been significantly compromised, with normal kidney and liver function, and without gastrointestinal ulcer, risk factors for irregular heartbeat, or life-threatening disease.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
23/EM/0218
Date of REC Opinion
13 Nov 2023
REC opinion
Further Information Favourable Opinion