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Recruiting NCT06412224

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

Early Phase I Interventional PDR - Proliferative Diabetic Retinopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RRG001.
Who it may be relevant to
Registry conditions: PDR - Proliferative Diabetic Retinopathy. Basic parameters: 20 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug RRG001
    Administered by subretinal injection. Dosage form: injection.

Primary outcome measures

  • To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts [Time frame: Within 28 days after RRG001 administration]
  • To evaluate the incidence of AEs(Adverse Event) as assessed CTCAE 5.0 at most 6 subjcts [Time frame: Within 24 weeks after RRG001 administration]
Secondary outcome measures (7)
  • To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects [Time frame: Within 24 weeks after RRG001 administration]
  • To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects [Time frame: Within 24 weeks after RRG001 administration]
  • To evaluate the frequency for rescue therapy of the study eye at most 6 subjects [Time frame: Within 24 weeks after RRG001 administration]
  • To evaluate the change from baseline in BCVA(Best Corrected Visual Acuity) of the study eye as assessed by ETDRS chart at most 6 subjects [Time frame: Within 24 weeks after RRG001 administration]
  • To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects [Time frame: Within 24 weeks after RRG001 administration]
  • To evaluate the anatomical changes of the study eye by CFP(colour fundus photography）at most 6 subjects [Time frame: Within 24 weeks after RRG001 administration]
  • To evaluate the anatomical changes of the study eye by OCTA（optical coherence tomography angiography) at most 6 subjects [Time frame: Within 24 weeks after RRG001 administration]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin medical university eye hospital — Tianjin

Identifiers

NCT: NCT06412224 · RRG001-P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗