The study focuses on Stargardt Disease, a rare inherited condition that slowly damages the central part of the retina and leads to loss of sharp vision. The investigational medicine being tested is an oral capsule that contains Gildeuretinol Acetate, a new drug intended to protect the retina, and it will be compared with a matching placebo capsule that contains no active ingredient.
The main goal of the trial is to find out whether the medication can slow the increase in the size of the damaged areas of the retina. The study is designed so that participants are randomly assigned to receive either the active drug or the placebo, and neither the participants nor the study staff will know which treatment is given. The trial will last about two years, with regular clinic visits for assessments.
During the study, participants will take one capsule each day and attend scheduled visits where several eye tests are performed. A special camera called FAF will take pictures that highlight unhealthy retinal tissue, while an imaging technique known as OCT will create cross‑sectional views of the eye’s layers. Vision will be measured using a standard eye chart (ETDRS) to determine BCVA, and low‑light reading ability will also be checked. Reading speed will be evaluated with two tests, IReST and MNRead. Sensitivity of the retina will be mapped with microperimetry, and participants will complete questionnaires such as the NEI-VFQ-25 to report how the condition affects daily activities.
Belgium 
France 
Italy 
