The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)

Prior treatment

• Previous gene therapy in either eye
• Previous condition not eligible for study drug

Other illness

• Active infection or inflammation in either eye
• History of major ocular surgery (except for PDR) or severe trauma
• Other conditions that, in the opinion of the investigator, would preclude participation in the study
  • Study Eye-Exclusion Criteria：
• Ocular disorders that, in the opinion of the investigator, would confound the interpretation of study results or affect the administration
• Ocular condition considered by the investigator to contraindicate subretinal injection
• History of intraocular corticosteroid treatment

Lab values

• HbA1c \>12% for diabetes patients at screening

Other

• Uncontrolled blood pressure（defined as systolic ≥160mmHg or diastolic ≥ 110mmHg by anti-hypertensive treatment)
• Currently enrolled in another clinical trial or planning to enroll during the study
• Pregnant or lactating women
• CNV or macular edema secondary to any causes other than diabetic retinopathy
• Diagnosed primary or secondary glaucoma

• Able and willing to provide informed consent
• Age \>= 20 years
• Diagnosis of diabetes mellitus (type 1 or type 2)
• The study eye diagnosed with PDR, in the opinion of the investigator, requires vitrectomy and postoperative anti-VEGF therapy, or that has undergone vitrectomy and still requires postoperative anti-VEGF therapy
• Based on the ETDRS chart, the best-corrected visual acuity (BCVA) of the study eye is ≥ hand motion and ≤ 63 letters