Gene therapy for diabetic eye disease after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tianjin medical university eye hospital
  Tianjin, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Feasibility of trained non-medical professionals performing laser treatment for PDR and impact on service delivery

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• ANXV (Annexin A5) infusions for non-proliferative diabetic retinopathy and retinal vein occlusion

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• OTX-TKI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy

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  Recruiting Phase 3 Ocular Therapeutix, Inc. · Hagerstown, Maryland · NCT07235085

• Evaluating TNTL for treating non-proliferative diabetic retinopathy

  This study is testing if a new drug called TNTL can help adults with non-proliferative diabetic retinopathy see better and stay safe compared to a placebo.

  Recruiting at 30 sites Phase 3 Beletalent (Zhuhai) Pharmaceutical Co., Ltd · Xuancheng, Anhui and 29 other locations · NCT06817265

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.