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

RecruitingEARLY Phase 1Ages 20 Years - 80 YearsAllLi Xiaorong
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • RRG001
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Where

1 site
Tianjin medical university eye hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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