Tests RRG001 gene therapy after eye surgery in proliferative diabetic retinopathy
Tests a single RRG001 gene therapy injection after vitrectomy in adults with diabetic eye disease.
Plain-language title generated from the registry record
Registry title: The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 80 years old?
Source: NCT06412224, who can take part
Where in China
- Tianjin Medical University Eye HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Li Xiaorong
- Trial code
- NCT06412224
- Record updated
- 14 May 2024
- Original description
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.Read full original descriptionShow less
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 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.
Inclusion: 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: Previous gene therapy in either eye; Previous condition not eligible for study drug; Active infection or inflammation in either eye; History of major ocular surgery (except for PDR) or severe trauma; 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; Ocular condition considered by the investigator to contraindicate subretinal injection; History of intraocular corticosteroid treatment; HbA1c >12% for diabetes patients at screening; Uncontrolled blood pressure（defined as systolic ≥160mmHg or diastolic ≥ 110mmHg by anti-hypertensive treatment); Currently enrolled in another clinical trial or planning to enroll during the study; Pregnant or lactating women; CNV or macular edema secondary to any causes other than diabetic retinopathy; Diagnosed primary or secondary glaucoma.