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Tests treatment safety and results for PDR - Proliferative Diabetic Retinopathy
Official title The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy (PDR)
ClinicalTrials.gov ID: NCT06412224
What this study is testing
What is RRG001?
RRG001 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pdr - proliferative diabetic retinopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- 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...
- Based on the ETDRS chart, the best-corrected visual acuity (BCVA) of the study eye is ≥ hand motion and ≤ 63 letters
You likely can't join if
- 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
See the full eligibility 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
- 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 corticosteroid treatment
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.