Overview
This study aims to slow down disease progression, reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy (PDR) by administering a single subretinal injection of RRG001 gene therapy after vitrectomy.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- Active infection or inflammation in either eye
- Previous gene therapy in either eye
- Uncontrolled blood pressure（defined as systolic ≥160mmHg or diastolic ≥ 110mmHg by anti-hypertensive treatment)
- HbA1c >12% for diabetes patients at screening
- Previous condition not eligible for study drug
- History of major ocular surgery (except for PDR) or severe trauma
- Currently enrolled in another clinical trial or planning to enroll during the study
- Pregnant or lactating women
- 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
- CNV or macular edema secondary to any causes other than diabetic retinopathy
- Ocular condition considered by the investigator to contraindicate subretinal injection
- Diagnosed primary or secondary glaucoma
- History of intraocular corticosteroid treatment