NCT06713720Recruiting
Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy
Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy (RIC-NPDR)
Source: ClinicalTrials.gov · Last updated 26 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 68 (estimated)
- First submitted
- 21 Nov 2024
- Start date
- 20 Apr 2025
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- Xuxiang Zhang, MD
- Diseases
- Type 2 diabetes, Diabetic eye disease
- NCT number
- NCT06713720
What you commit to
- Study type: Interventional
- Planned participants: 68
- From 20 Apr 2025 to the primary completion date, 30 Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Severe diabetes complications within the past 6 months.
- Severe, sustained hypertension (systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg).
- 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.
- Any other conditions deemed unsuitable by the investigator.
Lab values
- Unstable blood glucose (HbA1c ≥ 8.0%) despite oral antidiabetic drugs.
- 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.
Other
- Presence of diabetic macular edema (macular thickness \> 250 μm).
- Poor imaging quality due to refractive media opacity.
- Contraindication to fluorescein fundus angiography.
- Body mass index (BMI) ≥ 28 kg/m².
- Known pregnancy or breastfeeding.
- Participation in other experimental clinical studies.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
Related publications
- Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy (RIC-NPDR): study protocol for a randomized controlled trial.BMC Complement Med Ther · 2026 · PMID 41803826
This page is information, not medical advice. Discuss any trial with your doctor.