The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Dia… (NCT06412224) | Clinical Trial Compass
RecruitingEarly Phase 1
The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)
China6 participantsStarted 2023-12-20
Plain-language 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.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 corticosteroi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the incidence of DLTs (dose limiting toxicity analysis) at most 6 subjcts
Timeframe: Within 28 days after RRG001 administration
2
To evaluate the incidence of AEs(Adverse Event) as assessed CTCAE 5.0 at most 6 subjcts
Timeframe: Within 24 weeks after RRG001 administration