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

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06412224

Enrollment

Registered

2024-05-14

Start date

2023-12-20

Completion date

2028-12-31

Last updated

2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PDR - Proliferative Diabetic Retinopathy

Brief 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.

Interventions

DRUGRRG001

Administered by subretinal injection. Dosage form: injection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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-

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts	Within 28 days after RRG001 administration	To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
To evaluate the incidence of AEs(Adverse Event) as assessed CTCAE 5.0 at most 6 subjcts	Within 24 weeks after RRG001 administration	To evaluate the incidence of AEs as assessed CTCAE 5.0 at most 6 subjcts

Secondary

Measure	Time frame	Description
To evaluate the frequency for rescue therapy of the study eye at most 6 subjects	Within 24 weeks after RRG001 administration	To evaluate the frequency for rescue therapy of the study eye at most 6 subjects
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	Within 24 weeks after RRG001 administration	To evaluate the change from baseline in BCVA of the study eye as assessed by ETDRS chart at most 6 subjects
To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects	Within 24 weeks after RRG001 administration	To evaluate the disease progression as assessed the vitreous hemorrhage of the study eye at most 6 subjects
To evaluate the anatomical changes of the study eye by CFP(colour fundus photography）at most 6 subjects	Within 24 weeks after RRG001 administration	To evaluate the anatomical changes of the study eye by CFP(colour fundus photography）at most 6 subjects
To evaluate the anatomical changes of the study eye by OCTA（optical coherence tomography angiography) at most 6 subjects	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
To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects	Within 24 weeks after RRG001 administration	To evaluate the anatomical changes of the study eye by OCT(optical coherence tomography) at most 6 subjects
To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects	Within 24 weeks after RRG001 administration	To evaluate the disease progression as assessed the retinal detachment of the study eye at most 6 subjects

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026