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RecruitingEarly Phase 1NCT06412224

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

An Exploratory ITT（Investigator Initiated Study) Study to Evaluate the Preliminary Safety and Efficacy of Single Subretinal Injection of RRG001 at the End of or After Vitrectomy in Subjects With PDR

Sponsor

Li Xiaorong

Enrollment

6 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

PDR - Proliferative Diabetic Retinopathy

Summary

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

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria14

  • 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
  • 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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Interventions

DRUGRRG001

Administered by subretinal injection. Dosage form: injection.

Locations(1)

Tianjin medical university eye hospital

Tianjin, China

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NCT06412224