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New treatment option for Diabetic Retinopathy
Official title Remote Ischemic Conditioning for Non-Proliferative Diabetic Retinopathy
ClinicalTrials.gov ID: NCT06713720
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join 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 likely can't join 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...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.