Gene therapy for diabetic eye disease after surgery
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
This study is testing a new gene therapy for people with diabetic eye disease after surgery to see if it can help slow down the disease and reduce complications.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Eye Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06412224 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of RRG001 gene therapy administered via a single subretinal injection following vitrectomy in patients with proliferative diabetic retinopathy (PDR). The goal is to slow disease progression, minimize postoperative complications, and reduce the need for additional treatments. Participants must have a diagnosis of diabetes and meet specific visual acuity criteria. The study focuses on individuals who require vitrectomy and may benefit from postoperative anti-VEGF therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older with a diagnosis of diabetes and PDR requiring vitrectomy.
Not a fit: Patients with active eye infections, uncontrolled hypertension, or those who have previously undergone gene therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve visual outcomes and reduce the frequency of additional interventions for patients with PDR.
How similar studies have performed: While gene therapy for retinal diseases is an emerging field, this specific approach has not been extensively tested in prior studies, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tianjin
- Tianjin medical university eye hospital — Tianjin, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.