Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy

NCT06713720 | Recruiting

• 1 other identifier: CFH2024-2-20113
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetic Retinopathy; Non-Proliferative Diabetic Retinopathy; Remote Ischemic Conditioning; Diabetes Mellitus, Type 2; Randomized Controlled Trial

Keywords

Non-Proliferative Diabetic Retinopathy; Diabetic Retinopathy; Retinal Neurovascular Unit; Remote Ischemic Conditioning; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Diabetic Retinopathy Severity Score (DRSS)

  The primary outcome measure is the change in the Diabetic Retinopathy Severity Score (DRSS) from baseline to 1 year after intervention. The DRSS is a standardized grading system used to assess the severity of diabetic retinopathy, with changes reflecting disease progression or improvement.

  Baseline and 1 year after intervention

Secondary Outcomes (5)

• Incidence of Proliferative Diabetic Retinopathy (PDR)

  1 year after intervention

• Change in Retinal Neurovascular Unit Parameters

  Baseline and 1 year after intervention

• Change in Retinal Oxygen Saturation

  Baseline and 1 year after intervention

• Change in Visual Acuity

  Baseline and 1 year after intervention

• Change in Serum Biomarker Levels

  Baseline and 1 year after intervention

Other Outcomes (2)

• Incidence of Local Complications Related to Intervention

  Up to 1 year during intervention

• Retention Rate of Participants

  1 year after intervention

Study Arms (2)

Remote Ischemic Conditioning Group

EXPERIMENTAL

Participants in this group will receive remote ischemic conditioning (RIC) therapy. This involves five cycles of 5-minute inflation at 200 mmHg followed by 5-minute deflation, twice daily, for at least five days per week over a one-year period.

Device: Remote Ischemic Conditioning Device

Sham Remote Ischemic Conditioning Group

SHAM COMPARATOR

Participants in this group will receive sham remote ischemic conditioning therapy. This involves the same device with inflation pressure set at 60 mmHg, following identical timing and frequency as the intervention group.

Device: Sham Remote Ischemic Conditioning Device

Interventions

Remote Ischemic Conditioning Device DEVICE

Participants in this group will use a remote ischemic conditioning device that applies five cycles of 5-minute inflation at 200 mmHg followed by 5-minute deflation on both arms, twice daily, for at least five days per week over one year. The device is designed to enhance retinal oxygenation and reduce hypoxia-related damage.

Remote Ischemic Conditioning Group

Sham Remote Ischemic Conditioning Device DEVICE

Participants in this group will use the same remote ischemic conditioning device set to an inflation pressure of 60 mmHg to simulate the treatment. This placebo intervention follows the same timing and cycle frequency as the active intervention group.

Sham Remote Ischemic Conditioning Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Xuxiang Zhang, MD: lead
• Xuanwu Hospital, Beijing: collaborator

Study Sites (2)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

Xuanwu Hospital

Beijing, Beijing Municipality, 100730, China

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Shan He

CONTACT

86+19800328290; shanhe829@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Ophthalmology, Xuanwu Hospital

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 3, 2024
• Study Start: April 20, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)