Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Diabetic Retinopathy, Non-Proliferative Diabetic Retinopathy, Remote Ischemic Conditioning, Diabetes Mellitus, Type 2, Randomized Controlled Trial

In brief

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.

Key facts

Study ID

NCT06713720

Run by

Xuxiang Zhang, MD

People needed

68

Starts

2025-04-20

Expected to finish

2026-05-31

Last updated by the study team

2025-06-26

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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).
• Body mass index (BMI) ≥ 28 kg/m².
• Hepatic or renal insufficiency: Alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal. Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m². Urine albumin/creatinine ratio ≥ 30 mg/g.
• Myocardial infarction within the past 6 months.
• Neurological diseases such as Alzheimer's, Parkinson's, cerebrovascular disease, intracranial tumor, cerebrovascular malformation, or aneurysm.
• Contraindications to RIC, including one-sided subclavian artery stenosis, upper limb injuries or vascular diseases, or limb deformities.
• Severe systemic diseases, such as malignant tumors with a life expectancy of less than 24 months.
• Known pregnancy or breastfeeding.
• Participation in other experimental clinical studies.
• Any other conditions deemed unsuitable by the investigator.

Where it is running

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Xuanwu Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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