Diabetic RetinopathyPhase 4REVOLUTIONNCT07868458
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)
A Phase 4 study testing Resveratrol-Containing Vitamin Supplement in people with Diabetic Retinopathy and Non Proliferative Diabetic Retinopathy, run by University of Athens at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Non Proliferative Diabetic Retinopathy, Prospective Study
- What is being tested?
- Resveratrol-Containing Vitamin Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 30 Sep 2026to 30 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Second Department of Ophthalmology, School of Medicine, National and Kapodistrian University of Athens, Attikon University Hospital
Athens, 12462
About this study
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
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.
Read the detailed description
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.
- Being tested
- Resveratrol-Containing Vitamin Supplement
- Keywords
- diabetic retinopathy, Non proliferative diabetic retinopathy, vitamin supplement
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol-Containing Vitamin SupplementCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (1)
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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start30 Sep 2026
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irini Chatziralli, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868458
- Sponsor's protocol ID
- 476/2022
- Acronym
- REVOLUTION
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to patient confidentiality and data protection considerations.
Publications
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.
PubMed 23406761
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07868458
- Acronym / sponsor ID
- REVOLUTION / 476/2022
- Keywords
- diabetic retinopathy, Non proliferative diabetic retinopathy, vitamin supplement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- 30 Sep 2026 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resveratrol Supplementation | Experimental | Combination Product: Resveratrol-Containing Vitamin SupplementPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Proliferative diabetic retinopathy (PDR).
- Center-involved diabetic macular edema (DME).
- Age-related macular degeneration (AMD).
- Retinal vein occlusion.
- Uncontrolled glaucoma (intraocular pressure >30 mmHg).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resveratrol-Containing Vitamin SupplementPatients 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. | Combination product | Resveratrol Supplementation |
Primary outcome
Patients with improvement in diabetic retinopathy severity
Time frame: Baseline and 12 months
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.
1 secondary outcome
Change in retinal perfusion assessed by optical coherence tomography angiography (OCT-A)
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 23406761Soufi 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.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to patient confidentiality and data protection considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resveratrol-Containing Vitamin Supplement in people with Diabetic Retinopathy and Non Proliferative Diabetic Retinopathy, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with improvement in diabetic retinopathy severity (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07868458, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 31 Oct 2026.