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 range20 Years – 80 Years
SexALL
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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…
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