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

Li Xiaorong

Status and phase: Enrolling; Early Phase 1

Conditions: PDR - Proliferative Diabetic Retinopathy

Treatments: Drug: RRG001

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06412224

RRG001-P01

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

RRG001

Experimental group

Description:

Frequency of administration: one time injection.

Treatment:

Drug: RRG001