Randomized, Controlled Study to Investigate the 12-month Efficacy and Safety of Resveratrol Vitamin Supplements in Patients With Non-proliferative Diabetic Retinopathy Without Center Involved Diabetic Macular Edema (REVOLUTION Study)

NCT07868458 | Completed Phase 4

• 1 other identifier: 476/2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Retinopathy; Non Proliferative Diabetic Retinopathy; Prospective Study

Keywords

diabetic retinopathy; Non proliferative diabetic retinopathy; vitamin supplement

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 months

Secondary Outcomes (1)

• Change in retinal perfusion assessed by optical coherence tomography angiography (OCT-A)

  Baseline and 12 months

Study Arms (2)

Resveratrol Supplementation

EXPERIMENTAL

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

Control Group (Standard Care)

NO INTERVENTION

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.

Interventions

Resveratrol-Containing Vitamin Supplement COMBINATION_PRODUCT

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.

Resveratrol Supplementation

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with type 2 diabetes mellitus (T2DM).
• Presence of non-proliferative diabetic retinopathy (NPDR), classified according to the International Clinical Diabetic Retinopathy Disease Severity Scale (DRSS).
• Absence of center-involved diabetic macular edema (DME).
• Provision of written informed consent.

You may not qualify if:

• Proliferative diabetic retinopathy (PDR).
• Center-involved diabetic macular edema (DME).
• Age-related macular degeneration (AMD).
• Retinal vein occlusion.
• Uncontrolled glaucoma (intraocular pressure \>30 mmHg).
• Uveitis.
• Corneal or lens disorders that may interfere with ophthalmological examinations or imaging.
• Other ocular diseases that may affect study outcomes.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Second Department of Ophthalmology, School of Medicine, National and Kapodistrian University of Athens, Attikon University Hospital

Athens, 12462, Greece

Location

Related Publications (1)

• Soufi FG, Mohammad-Nejad D, Ahmadieh H. Resveratrol improves diabetic retinopathy possibly through oxidative stress - nuclear factor kappaB - apoptosis pathway. Pharmacol Rep. 2012;64(6):1505-14. doi: 10.1016/s1734-1140(12)70948-9.

  PMID: 23406761 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology, University of Athens

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: September 30, 2026
• Primary Completion: September 30, 2026
• Study Completion: September 30, 2026
• Last Updated: October 9, 2026

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)