Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy
Eligible age
40–80 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
The goal of this clinical trial is to evaluate whether remote ischemic conditioning (RIC) is a safe and effective treatment for non-proliferative diabetic retinopathy (NPDR) in adults aged 40-80 years with type 2 diabetes. The study aims to address the limitations of current treatments for NPDR by using RIC, a technique involving repeated cycles of ischemia and hypoxia stimulation to activate protective mechanisms against retinal damage. The main questions it aims to answer are: Does RIC improve the Diabetic Retinopathy Severity Score (DRSS) after one year of treatment? Does RIC reduce the incidence of vision-threatening proliferative diabetic retinopathy (PDR)? What are the changes in retinal neurovascular unit parameters, visual acuity, and retinal oxygen saturation after RIC treatment? Participants will: Undergo RIC therapy using a specialized device on both upper limbs (or a placebo intervention for the control group) for 1 year. Complete 5 cycles of RIC or placebo treatment twice daily, 5 days per week. Receive routine care for diabetic retinopathy as per clinical guidelines. Key outcome measures: Primary outcome: Change in DRSS from baseline after one year. Secondary outcomes: Incidence of PDR, changes in visual acuity, retinal neurovascular unit measures, retinal oxygen saturation, and serum biomarkers (e.g., VEGF, CRP, IL-6). This randomized, double-blind, placebo-controlled trial aims to recruit 68 participants to ensure 60 complete the study, accounting for a 13% dropout rate. The findings are expected to provide insights into RIC as a novel intervention for NPDR, reducing blindness risk and supporting future large-scale trials.
Sponsor: Xuxiang Zhang, MD
You may qualify if…
- ✓ Age between 40 and 80 years.
- ✓ Diagnosed with Type 2 diabetes mellitus.
- ✓ Diagnosed with mild to moderate non-proliferative diabetic retinopathy (NPDR) with a DR Severity Score (DRSS) grade of 20-47D.
- ✓ Capable of performing daily activities independently.
- ✓ Willing and able to provide informed consent.
You may not qualify if…
- ✕ Presence of diabetic macular edema (macular thickness \> 250 μm).
- ✕ Significant eye diseases affecting evaluation, such as high myopia, severe cataract, corneal leucoma, glaucoma, retinal detachment, retinal vein occlusion, congenital eye diseases, ocular tumors, or severe infection.
- ✕ History of ocular laser or intraocular surgery.
- ✕ Poor imaging quality due to refractive media opacity.
- ✕ Contraindication to fluorescein fundus angiography.
- ✕ Unstable blood glucose (HbA1c ≥ 8.0%) despite oral antidiabetic drugs.
- ✕ Severe diabetes complications within the past 6 months.
- ✕ Severe, sustained hypertension (systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg).
Source: ClinicalTrials.gov · NCT06713720 · last updated 2025-06-26