Safety and Efficacy of a Single Subretinal Injection of JWK006 Gene Therapy in Subjects With Stargardt Disease(STGD1)

Exclusion Criteria

• •1\) The study eye has other conditions that may cause vision loss (such as optic atrophy, advanced glaucoma, and uveitis); (2) The presence of lens, cornea or other refractive stromal opacity in the study eye affects retinal observation and examination; (3) There are eye conditions that affect subretinal injection, or eye conditions that affect the judgment of the study endpoint; (4) Those who have undergone intraocular surgery in the study eye within 6 months; (5) Patients with AAV8 neutralizing antibody titer ≥1:1000; (6) Have received any gene therapy or cell therapy in the past; (7) Subjects of childbearing age are unwilling to use contraceptive measures; (8) One of the following situations exists: the researcher believes that there is an active infection that may affect the patient's participation in the study or that affects the study results and requires systemic treatment; hepatitis B surface antigen is positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) copies number \> ULN; hepatitis C virus (HCV) antibody positive, and HCV-RNA copy number \> ULN; Treponema pallidum antibody positive; human immunodeficiency virus (HIV) antibody positive; (9) Malignant tumors diagnosed within 5 years before screening (except for adequately treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, and breast ductal carcinoma in situ after radical mastectomy); (10) Suffering or having suffered from systemic immune system diseases; (11) Abnormal laboratory values considered to be clinically significant: alanine aminotransferase and/or aspartate aminotransferase \>2.5×ULN, total bilirubin \>1.5×ULN, serum creatinine \>1.5×ULN, prothrombin time ≥1.5× ULN, activated partial thromboplastin time ≥1.5×ULN; (12) There is severe allergy or known allergy to the drugs used for treatment or examination in the research protocol, including allergy to study drugs; (13) Pregnant and lactating women; subjects with childbearing potential who are unable to take effective contraceptive measures within 2 weeks before screening to 6 months after administration; (14) Other circumstances that the researcher believes are not suitable for participating in this study.