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.
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;
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;
Sequential
PUMCH-E111 Injection（Low dose）
GeneticSingle intravitreal injection
PUMCH-E111 Injection（High dose）
GeneticSingle intravitreal injection
Incidence of DLTs
Number and proportion of dose limited toxicity (DLTs)
Incidence of AEs
Number and severity of overall and ocular Adverse Events (AEs)
Incidence of SAEs
Number and severity of overall and ocular Serious Adverse Events (SAEs)
Visual function
Change from baseline in BCVA (Best Corrected Visual Acuity) (ETDRS)
Visual function
Change from baseline in LLVA (Low-Luminance Visual Acuity) (ETDRS)
Visual function
Change from baseline in the mean value of the photosensitivity threshold (Dark adaption Threshold Curve)
Visual function
Change from baseline in mean sensitivity (MS) (Static visual field)
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