A Phase 4 interventional study of Resveratrol-Containing Vitamin Supplement in Diabetic Retinopathy, Non Proliferative Diabetic Retinopathy and Prospective Study, sponsored by University of Athens. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of Athens · Phase 4, Interventional, and Treatment
This randomized, controlled study aims to investigate the efficacy and safety of resveratrol-containing vitamin supplements in patients with non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (DME).
Patients with diabetes mellitus and NPDR attending the Second Department of Ophthalmology will be enrolled and randomly assigned to a supplementation or control group. During the 12-month follow-up period, the study will evaluate the potential effects of resveratrol supplementation on diabetic retinopathy, including changes in disease severity and progression, while also monitoring its safety and tolerability.
Diabetic retinopathy (DR) is a common microvascular complication of diabetes mellitus and a leading cause of visual impairment. Oxidative stress and inflammation play important roles in its pathogenesis. Resveratrol, a naturally occurring polyphenol with antioxidant and anti-inflammatory properties, has been proposed as a potential supplementary treatment for diabetic retinopathy.
The REVOLUTION study is a prospective, randomized, controlled clinical trial designed to investigate the efficacy and safety of resveratrol-containing vitamin supplements in patients with non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (DME).
Patients attending the Second Department of Ophthalmology will be enrolled and randomly assigned to either a resveratrol-containing vitamin supplementation group or a control group. Participants will be followed for 12 months to assess changes in diabetic retinopathy severity, potential disease progression, and the safety and tolerability of supplementation.
The study aims to determine whether resveratrol-containing vitamin supplements may provide additional clinical benefits in the management of NPDR and help prevent disease progression.
791 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 491 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →University of Athens is the lead sponsor of 139 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Patients with non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema will receive a resveratrol-containing vitamin supplement for 12 months. Ophthalmological assessments will be performed at baseline and at 3, 6, and 12 months to evaluate efficacy, disease progression, and safety.
Combination Product: Resveratrol-Containing Vitamin Supplement
Patients with non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema will receive standard clinical care without resveratrol supplementation. Ophthalmological assessments will be performed at baseline and at 3, 6, and 12 months for comparison with the intervention group.
Patients with non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema will receive an approved oral resveratrol-containing vitamin supplement for 12 months. The efficacy and safety of supplementation will be evaluated through ophthalmological examinations at baseline and at 3, 6, and 12 months.
Patients with improvement in diabetic retinopathy severity
The proportion of patients demonstrating improvement in diabetic retinopathy severity, assessed using the International Clinical Diabetic Retinopathy Disease Severity Scale (DRSS) at month 12 compared with baseline.
Time frame: Baseline and 12 months
Change in retinal perfusion assessed by optical coherence tomography angiography (OCT-A)
Changes in retinal microvascular perfusion and ischemia-related parameters assessed using OCT-A at month 12 compared with baseline.
Time frame: Baseline and 12 months
Plan to share: No — Individual participant data (IPD) will not be publicly shared due to patient confidentiality and data protection considerations.
Ran from Sep 2026 to primary completion in Sep 2026, 0 months.
Of 33 phase 4 interventional studies under Diabetic Retinopathy, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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