This clinical trial is focused on studying Stargardt Disease, a genetic eye disorder that affects vision, particularly in adolescents. The study is testing a treatment called Tinlarebant, also known by its code name LBS-008. This medication is taken in the form of a tablet. The purpose of the study is to evaluate how effective Tinlarebant is in slowing down the progression of vision loss in young people with Stargardt Disease.
Participants in the study will be randomly assigned to receive either Tinlarebant or a placebo. The study is designed to be “double-masked,” meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are unbiased. The study will take place over a period of time, during which participants will have regular check-ups to monitor their eye health and any changes in their vision.
The main goal of the study is to see if Tinlarebant can slow the growth of areas in the eye that are losing function, known as atrophic lesions. These areas are monitored using a special type of eye photography called FAF (fundus autofluorescence). Additionally, the study will look at changes in the thickness and structure of the retina, the part of the eye that is crucial for vision, using a method called SDOCT (spectral-domain optical coherence tomography). The study aims to provide valuable information on the safety and effectiveness of Tinlarebant for treating Stargardt Disease in adolescents.



Belgium
France
Germany
The Netherlands