Actively Recruiting
Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy (RIC-NPDR)
Led by Xuxiang Zhang, MD · Updated on 2025-06-26
68
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
X
Xuxiang Zhang, MD
Lead Sponsor
X
Xuanwu Hospital, Beijing
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating remote ischemic conditioning (RIC) as a possible treatment for adults aged 40 to 80 years with mild to moderate non-proliferative diabetic retinopathy (NPDR) caused by type 2 diabetes. This study aims to see if RIC can improve the Diabetic Retinopathy Severity Score (DRSS), reduce the risk of vision-threatening proliferative diabetic retinopathy (PDR), and affect retinal and blood markers linked to eye health. NPDR is an early stage of diabetic retinopathy where current treatments have limitations, so this study tests a new, non-invasive approach. Participants will be randomly assigned to receive either RIC therapy or a placebo (sham) treatment using a specialized device. The RIC group will undergo five cycles of 5-minute arm cuff inflation at 200 mmHg followed by 5-minute deflation, done twice daily, five days per week for one year. The placebo group will have the same cycles but at a lower pressure of 60 mmHg to mimic the treatment without the active effect. Both groups will continue routine diabetic retinopathy care according to clinical guidelines. During the study, participants will have regular assessments of their eye health, including changes in DRSS, retinal nerve and blood vessel function, retinal oxygen levels, visual acuity, and blood tests for markers like VEGF, CRP, and IL-6. Safety and treatment effects will be monitored over the one-year treatment period. The study plans to recruit 68 participants to ensure enough data despite some expected dropouts and aims to provide early evidence on RIC's potential for managing NPDR and preventing vision loss.
CONDITIONS
Brief Title
Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Presence of diabetic macular edema with macular thickness greater than 250 bcm.
- 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 6ge; 8.0%) despite oral antidiabetic drugs.
- Severe diabetes complications within the past 6 months.
- Severe, sustained hypertension (systolic 6ge; 180 mmHg or diastolic 6ge; 110 mmHg).
- Body mass index (BMI) 6ge; 28 kg/m�b2.
- Hepatic or renal insufficiency: elevated liver enzymes greater than twice normal, low eGFR below 60 mL/min/1.73m�b2, or urine albumin/creatinine ratio above 30 mg/g.
- Myocardial infarction within the past 6 months.
- Neurological diseases including Alzheimer's, Parkinson's, cerebrovascular disease, intracranial tumor, cerebrovascular malformation, or aneurysm.
- Contraindications to RIC such as one-sided subclavian artery stenosis, upper limb injuries or vascular diseases, or limb deformities.
- Severe systemic diseases like malignant tumors with life expectancy under 24 months.
- Known pregnancy or breastfeeding.
- Participation in other experimental clinical studies.
- Any other conditions deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 year
Participants use a remote ischemic conditioning device or a sham device on both arms. This involves five cycles of 5-minute inflation and 5-minute deflation, twice daily, for at least five days per week over one year to evaluate effects on diabetic retinopathy.
Regular visits for assessments during treatment period
Duration - Assessment at 1 year after intervention
Participants undergo assessments to evaluate changes in diabetic retinopathy severity, retinal function, visual acuity, and serum biomarkers after the treatment period.
1 visit (in-person) at 1 year
Trial Site Locations
Total: 2 locations
1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
Xuanwu Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
Research Team
S
Shan He
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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