Actively Recruiting
The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)
Led by Li Xiaorong · Updated on 2024-05-14
6
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
L
Li Xiaorong
Lead Sponsor
S
Shanghai Refreshgene Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent
- Age 20 years or older
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Study eye diagnosed with PDR that requires vitrectomy and postoperative anti-VEGF therapy, or has undergone vitrectomy and still requires postoperative anti-VEGF therapy
- Best-corrected visual acuity (BCVA) of the study eye is at least hand motion and no more than 63 letters based on ETDRS chart
You will not qualify if you...
- Active infection or inflammation in either eye
- Previous gene therapy in either eye
- Uncontrolled blood pressure (systolic ≥160 mmHg or diastolic ≥110 mmHg despite treatment)
- HbA1c greater than 12% 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 would prevent study participation as judged by investigator
- Ocular disorders that could affect study results or treatment administration
- Choroidal neovascularization or macular edema from causes other than diabetic retinopathy
- Eye conditions that contraindicate subretinal injection
- Diagnosed primary or secondary glaucoma
- History of intraocular corticosteroid treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin medical university eye hospital
Tianjin, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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