Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy

Launched by XUXIANG ZHANG, MD · Nov 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called remote ischemic conditioning (RIC) to see if it can help adults aged 40 to 80 with type 2 diabetes and a condition known as non-proliferative diabetic retinopathy (NPDR). NPDR is a common eye condition that can lead to vision problems. The trial aims to find out if RIC, which involves a special device that causes temporary changes in blood flow, can improve eye health and reduce the risk of more serious vision issues over a year of treatment.

To participate, individuals must be between 40 and 80 years old, have type 2 diabetes, and have a specific level of NPDR. Participants will either receive RIC treatment or a placebo (a harmless version that doesn’t have the active treatment) for about a year, while also continuing their usual eye care. This study is important because it could lead to new ways to protect against blindness related to diabetic eye diseases. The researchers hope to learn if RIC can make a difference in eye health and overall wellbeing for those living with diabetes.

Gender

ALL

Eligibility 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.