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COMPLETED
NCT07868458
PHASE4

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)

Sponsor: University of Athens

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-09-30

Completion Date

2026-09-30

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Resveratrol-Containing Vitamin Supplement

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.

Locations (1)

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

Athens, Greece