About this trial
The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E111 injection in subjects with RLBP1 related Inherited Retinal Dystrophy.
Eligibility criteria
Qualifiers
Subjects voluntarily participate and sign the informed consent form;
Age between 18-55 years old, gender is not limited;
Clinical diagnosis of IRD caused by RLBP1 mutations;
For the study eye, residual visual field within the 30° central field is tested using Program G or Program LVC on the Octopus perimeter;
Disqualifiers
Opacity of refractive media or inability to dilate pupils in the study eye that significantly interferes with visual acuity detection, anterior segment or fundus assessment;
Presence of diabetic retinopathy, retinal vein occlusion, pathological myopia, retinal detachment, or other conditions in the study eye that are assessed by the investigator as affecting the safety of the subject or the validity of the study;
Active intraocular or periocular infection (such as blepharitis, conjunctivitis, keratitis, scleritis, etc.) in the study eye;
History of vitreous hemorrhage in the study eye within 6 months prior to screening;
Trial design
Treatments tested in this trial
- PUMCH-E111 Injection(Low dose)
- PUMCH-E111 Injection(High dose)