Diabetic RetinopathyOMEDIANCT04499820
Effect of OMEGA3 Supplementation in Diabetic Retinopathy
A study testing Nutrof and Meralut in people with Diabetic Retinopathy, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Nutrof and Meralut
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2020to 17 Apr 2025
- Phase
- Interventional
- 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
- ≥18 years
- For women of childbearing age, an effective method of contraception is introduced and monitored throughout their participation in the study.
- Diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy according to the ETDRS (EarlyTreatment of DiabeticRetinopathyStudy) classification.
- AV > 6/10
- One eye included. If both are affected, the eye with the poorer perfusion should be included.
- Affiliated to a social security scheme
Who cannot join
- < 18 years old.
- Pregnant or breastfeeding woman
- Other retinal pathologies that may interfere with the results (Patients previously treated with anti-VEGF, aflibercept or intra-vitreal corticosteroids, history of glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema, macular thickness > 280 µm, Eyes with spherical equivalent greater than 8 Diopters, OCTA images not interpretable with many artifacts.)
- Hypersensitivity to any of the components of Nutrof or Meralut
- Taking the antivitamin k
- Known deficit in G6PD-
Show all 14Show fewer
- History of renal lithiasis
- Kidney failure
- Immunosuppression
- Chronic Ethylism
- History of hepatopathy
- Intracranial tumor, intracranial hypertension
- Refusal to participate
- Patient participating in an intervention study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique
The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.
Read the detailed description
Diabetic retinopathy (DR) is a leading cause of vision loss worldwide and is a major public health problem.
In Western countries, the prevalence of DR is estimated to be 35% in diabetic patients, while diabetic macular edema (DME) affects 5% of them.
Currently, apart from the balance of diabetes and other cardiovascular risk factors, no specific treatment is given for the minimal and moderate non-proliferative forms.
- DHA concentration in the retina can be modified according to the patient's diet.
- Minimal diabetic retinopathy does not currently benefit from specific treatment outside of diabetic control.
- Omega 3 are already known for their beneficial effects on the retina, brain and cardiovascular system but their effectiveness has not been tested on diabetic retinopathy.
- It is therefore a question of evaluating whether an omega 3 supplementation, at a dosage of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy.
A study by Salavila et al. has shown that the intake of LCω3PUFA, via a Mediterranean diet, improved the stage of DR in diabetic patients.
- Conditions
- Diabetic Retinopathy
- Being tested
- Nutrof, Meralut
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutrofDietary supplement
DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.
MeralutDietary supplement
vitamin A, natural flavonoids, lutein and zeaxanthin
| Study group | Role | What they receive |
|---|---|---|
| NUTROF Group | Experimental | vitamin and DHA supplementation Receives: Dietary Supplement: Nutrof |
| MERALUT Group | Placebo comparator | vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA Receives: Dietary Supplement: Meralut |
What is being measured
The primary outcome is the main question the study is designed to answer.
density of the deep capillary plexus in optical coherence tomography angiography (OCTA)
Macular vascularization consists of three interconnected capillary plexuses: the superficial capillary plexus (SCp) located at the level of the optic fibres and the intermediate (ICP) and deep (DCP) capillary plexuses located respectively at the level of the inner and outer part of the inner nuclear layer.16 OCTA is a non-invasive imaging method of retinal vasculature that allows a qualitative but mainly quantitative analysis of the capillary plexuses. A last parameter that could not be evaluated precisely with the old fluorescein and OCT angiography techniques. OCTA is performed without injection of intravenous contrast agent and has no side effects. Several studies have shown that PCP is the plexus most affected by non-perfusion areas in diabetic retinopathy.
Measured: six months
Secondary outcomes (9)
capillary plexus density in OCTA
capillary plexus density
Measured: six months
area (mm²) of the central avascular zone in OCTA
area (mm²
Measured: six months
Visual acuity measurement ETDRS
Visual acuity
Measured: six months
Stage of diabetic retinopathy: minimal, moderate or severe
Each stage of retinopathy may be associated with some degree of diabetic macular edema; macular edema is classified as minimal, moderate or severe, depending on its location relative to the centre of the macula. It is considered severe when it reaches the centre of the macula.
Non-proliferative diabetic retinopathy (NPDR, no neo-vessels) Minimal non-proliferative DR (some microaneurysms or punctiform hemorrhages).
- Moderate nonproliferative DR (by exclusion if neither minimal nor severe DRNP)
- Severe nonproliferative DR (or preproliferative DR): "4, 2, 1" rule (retinal hemorrhages in 4 quadrants and/or venous dilatations in 2 quadrants and/or AMIR in 1 quadrant)
Measured: six months
central retinal thickness (µm) in the 2 groups at 6 months
central retinal thickness
Measured: six months
cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol
cholesterol leve
Measured: six months
triglycerid level
triglycerid level
Measured: six months
glycated haemoglobin (percent)
In diabetes, the higher the blood glucose level, the more glucose attaches to hemoglobin and the higher the level of glycated hemoglobin. It therefore indicates whether the blood glucose level was, on average, higher or lower during the 2 months prior to the test. Glycated haemoglobin is measured every 2-4 months. A small amount of blood is drawn from a vein or from the fingertip (micro-method).
Glycated haemoglobin (HbA1c) is a fundamental criterion for blood sugar control. It is essential for assessing the risk of complications.
9% Very high 7% Recommended 5% Normal
Measured: six months
Diet questionnaire
questionnaire
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start26 Jun 2020
- Primary completion10 Oct 2024
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoires Thea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04499820
- Sponsor's protocol ID
- OMEDIA
- Acronym
- OMEDIA
- Status last verified
- Nov 2025
- First submitted
- 3 Jul 2020
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique
- ClinicalTrials.gov ID
- NCT04499820
- Acronym / sponsor ID
- OMEDIA / OMEDIA
- Conditions
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Laboratoires Thea
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 5 Aug 2020 (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.
The main objective of this study is to evaluate the efficacy at 6 months of omega 3 supplementation on macular capillary density measured in optical coherence tomography angiography in patients with minimal or moderate non proliferative diabetic retinopathy.
Detailed description
Diabetic retinopathy (DR) is a leading cause of vision loss worldwide and is a major public health problem.
In Western countries, the prevalence of DR is estimated to be 35% in diabetic patients, while diabetic macular edema (DME) affects 5% of them.
Currently, apart from the balance of diabetes and other cardiovascular risk factors, no specific treatment is given for the minimal and moderate non-proliferative forms.
- DHA concentration in the retina can be modified according to the patient's diet.
- Minimal diabetic retinopathy does not currently benefit from specific treatment outside of diabetic control.
- Omega 3 are already known for their beneficial effects on the retina, brain and cardiovascular system but their effectiveness has not been tested on diabetic retinopathy.
- It is therefore a question of evaluating whether an omega 3 supplementation, at a dosage of 1000mg per day, can treat a minimal or moderate stage of diabetic retinopathy.
A study by Salavila et al. has shown that the intake of LCω3PUFA, via a Mediterranean diet, improved the stage of DR in diabetic patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NUTROF Group | Experimental | Dietary Supplement: Nutrofvitamin and DHA supplementation |
| MERALUT Group | Placebo comparator | Dietary Supplement: Meralutvitamin A, natural flavonoids, lutein and zeaxanthin and no DHA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years
- For women of childbearing age, an effective method of contraception is introduced and monitored throughout their participation in the study.
- Diabetic microangiopathy: minimal to moderate nonproliferative diabetic retinopathy according to the ETDRS (EarlyTreatment of DiabeticRetinopathyStudy) classification.
- AV > 6/10
- One eye included. If both are affected, the eye with the poorer perfusion should be included.
Key exclusion criteria (14 listed)
- < 18 years old.
- Pregnant or breastfeeding woman
- Other retinal pathologies that may interfere with the results (Patients previously treated with anti-VEGF, aflibercept or intra-vitreal corticosteroids, history of glaucoma, vitrectomy, retinal laser, epiretinal membrane), choroidal neo-vascularization, uveitis, retinal vascular occlusion, significant macular edema, macular thickness > 280 µm, Eyes with spherical equivalent greater than 8 Diopters, OCTA images not interpretable with many artifacts.)
- Hypersensitivity to any of the components of Nutrof or Meralut
- Taking the antivitamin k
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 |
|---|---|---|
| NutrofDHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies. | Dietary supplement | NUTROF Group |
| Meralutvitamin A, natural flavonoids, lutein and zeaxanthin | Dietary supplement | MERALUT Group |
Primary outcome
density of the deep capillary plexus in optical coherence tomography angiography (OCTA)
Time frame: six months
Macular vascularization consists of three interconnected capillary plexuses: the superficial capillary plexus (SCp) located at the level of the optic fibres and the intermediate (ICP) and deep (DCP) capillary plexuses located respectively at the level of the inner and outer part of the inner nuclear layer.16 OCTA is a non-invasive imaging method of retinal vasculature that allows a qualitative but mainly quantitative analysis of the capillary plexuses. A last parameter that could not be evaluated precisely with the old fluorescein and OCT angiography techniques. OCTA is performed without injection of intravenous contrast agent and has no side effects. Several studies have shown that PCP is the plexus most affected by non-perfusion areas in diabetic retinopathy.
9 secondary outcomes
capillary plexus density in OCTA
Time frame: six months
area (mm²) of the central avascular zone in OCTA
Time frame: six months
Visual acuity measurement ETDRS
Time frame: six months
Stage of diabetic retinopathy: minimal, moderate or severe
Time frame: six months
central retinal thickness (µm) in the 2 groups at 6 months
Time frame: six months
cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol
Time frame: six months
triglycerid level
Time frame: six months
glycated haemoglobin (percent)
Time frame: six months
Diet questionnaire
Time frame: six 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 4 Dec 2025.
- Individual participant dataSharing planned: No
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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 study testing Nutrof and Meralut in people with Diabetic Retinopathy, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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 6 inclusion and 14 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 4 Dec 2025. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
density of the deep capillary plexus in optical coherence tomography angiography (OCTA) (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.