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

Recruiting now · Early Phase 1

Conditions studied: PDR - Proliferative Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT06412224

Run by

Li Xiaorong

People needed

6

Starts

2023-12-20

Expected to finish

2028-12-31

Last updated by the study team

2024-05-14

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tianjin medical university eye hospital — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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