Safety and Efficacy of ZVS101e in Patients With Bietti 's Crystalline Dystrophy

Inclusion Criteria:

1. Fully understand the purpose and requirements of this trial, voluntarilyparticipate in the clinical trial, sign the informed consent form, and be ableto complete the whole trial processes as required by the protocol;

2. Patients with clinical diagnosis of Bietti's crystalline dystrophy (BCD) (age ≥ 18 years) (including the critical value, and the age is based on the time ofsigning the informed consent form);

3. Genetic test confirmed to carry two pathogenic variants of CYP4V2 and carry nopathogenic mutations of other ophthalmic genetic diseases;

4. The study eye must meet the following requirements: Best-corrected visualacuity between 2.3 LogMAR and 0.5 LogMAR (including 2.3 LogMAR and 0.5 LogMAR).

Exclusion Criteria:

1. Subjects with insufficient viable retinal cells, or macular retinal less than 100 μm thick;

2. Pre-existing eye conditions in the study eye that the investigator determinescould interfere with ocular evaluation, preclude surgery, interfere withinterpretation of study endpoints or pose surgical complications;

3. The study eye has been treated with the following intraocular procedures:retinal detachment surgery, vitrectomy;

4. The study eye has been treated with other drugs within 3 months that couldaffect the evaluation of the investigational drug (such as ranibizumab,bevacizumab, aflibercept, conbercept);

5. Currently taking or may require systemic medications that can cause oculartoxicity, such as psoralen, risedronate, or tamoxifen;

6. Those with the following laboratory abnormalities which are clinicallysignificant:

• Liver function: chronic liver disease, ALT increased > 2 times the upper limitof normal;

• Hypertension, mean SBP ≥ 160 mmHg or mean DBP ≥ 100 mmHg;

• Coagulation function (prothrombin time ≥ upper limit of normal (3 seconds'longer), activated partial thromboplastin time ≥ upper limit of normal (10seconds' longer));

• Serum virology test: Active hepatitis B, hepatitis C virus antibody (HCV-Ab),human immunodeficiency virus antibody (HIV-Ab) or syphilis antibody positive;

7. Patients with rAAV8 neutralizing antibody titer ≥ 1:1000;

8. Complicating systemic diseases (such as medical conditions causingimmunosuppression) that would preclude the gene transfer, ocular surgery anddrug in vivo activity;

9. Known drug allergy to the drug planned to be used in the study;

10. Patients who cannot communicate or cooperate with medical staff due toneurological, mental illness or language disorder, which affects patientcompliance;

11. Treatment of either eye with gene therapy drugs for BCD and other oculardiseases, including but not limited to other viral vector gene therapies, mRNAtherapy, etc.;

12. Has or has had a systemic immune-compromising disease;

13. Subjects of reproductive age without any effective contraception and femalesubjects who have tested positive for pregnancy or are lactating at screeningor baseline;

14. A condition that, in the opinion of the investigator, would precludeparticipation in the study.