Remote ischemic conditioning to treat early diabetic retinopathy
Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy (RIC-NPDR)
This trial will test whether remote ischemic conditioning — brief, repeated arm cuff inflations — helps adults aged 40–80 with mild-to-moderate non-proliferative diabetic retinopathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06713720 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 40–80 years with type 2 diabetes, mild-to-moderate NPDR (DRSS 20–47D), reasonably stable glucose control, and ability to attend regular clinic visits are the ideal candidates.
Not a fit: Patients with diabetic macular edema, advanced proliferative disease, recent ocular surgery or laser, poor imaging quality, contraindications to angiography, unstable blood glucose (HbA1c ≥ 8% despite treatment), or severe systemic illness are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, RIC could slow or reverse progression of early diabetic retinopathy and reduce the need for invasive eye treatments.
How similar studies have performed: Preclinical studies and small clinical reports suggest RIC can protect retinal tissue and improve oxygenation, but large randomized trials for NPDR are not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.