ZVS101e in Patients With Bietti's Crystalline Dystrophy

Inclusion criteria

• Voluntarily participate in the research and sign the informed consent form, and be willing to complete the entire process according to the protocol requirements;
• Clinically diagnosed with Bietti's Crystalline Dystrophy (BCD), age ≥ 18 years;
• Confirmed by genetic testing to carry homozygous or compound heterozygous mutations in CYP4V2, and not complicated with other ophthalmic genetic diseases;
• Target eye BCVA ≤ 60 ETDRS letters.

Exclusion criteria

Subjects will be excluded if they meet any 1 of the following exclusion criteria:

• The target eye currently has or has a history of macular lesions; suffers from ocular diseases that may hinder surgery or interfere with the interpretation of study endpoints;
• The target eye has previously undergone retinal reattachment surgery, vitrectomy, or any intraocular surgery within 3 months before enrollment;
• Within 1 month before enrollment, suffered from viral infectious diseases that may affect the evaluation of the efficacy and safety of the investigational drug, or received antiviral vaccines;
• The target eye has previously received gene therapy or stem cell therapy for BCD or other ocular diseases;
• Known allergy to the drugs planned for use in the study;
• The laboratory abnormalities are considered clinically significant;
• Pregnant or lactating females.