The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)
NCT ID: NCT06412224
Last Updated: 2024-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
6 participants
INTERVENTIONAL
2023-12-20
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RRG001
Frequency of administration: one time injection.
RRG001
Administered by subretinal injection. Dosage form: injection.
Interventions
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RRG001
Administered by subretinal injection. Dosage form: injection.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Shanghai Refreshgene Technology Co., Ltd.
INDUSTRY
Li Xiaorong
OTHER
Responsible Party
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Li Xiaorong
Assistant Investigator
Locations
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Tianjin medical university eye hospital
Tianjin, , China
Countries
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Facility Contacts
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Other Identifiers
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RRG001-P01
Identifier Type: -
Identifier Source: org_study_id
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