Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy

Summary

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.

Eligibility

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.

Conditions6

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