Remote ischemic conditioning to treat early diabetic retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled trial testing remote ischemic conditioning (RIC) delivered by an arm cuff device versus a sham procedure over one year. Participants with type 2 diabetes and mild-to-moderate NPDR will receive daily RIC cycles (200 mmHg inflation) or sham cycles (60 mmHg) and undergo regular clinical and imaging assessments. Primary outcomes include change in Diabetic Retinopathy Severity Score (DRSS) at one year and incidence of progression to proliferative disease; secondary outcomes include retinal neurovascular parameters, visual acuity, and retinal oxygen saturation. Safety and tolerability of long-term RIC will also be monitored.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Xuanwu Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Shan He
• Email: shanhe829@163.com
• Phone: 86+19800328290

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.