An interventional study of Nutrof and Meralut in Diabetic Retinopathy, sponsored by Centre Hospitalier Intercommunal Creteil. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-04.
Sponsored by Centre Hospitalier Intercommunal Creteil · Not applicable, Interventional, and Supportive care
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.
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.
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.
772 studies on the registry are indexed under Diabetic Retinopathy; 138 are open to participants now.
This study's enrollment of 60 is below the median of 78 across 479 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
vitamin and DHA supplementation
Dietary Supplement: Nutrof
vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA
Dietary Supplement: Meralut
DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.
vitamin A, natural flavonoids, lutein and zeaxanthin
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.
Time frame: six months
capillary plexus density in OCTA
capillary plexus density
Time frame: six months
area (mm²) of the central avascular zone in OCTA
area (mm²
Time frame: six months
Visual acuity measurement ETDRS
Visual acuity
Time frame: 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)
Time frame: six months
central retinal thickness (µm) in the 2 groups at 6 months
central retinal thickness
Time frame: six months
cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol
cholesterol leve
Time frame: six months
triglycerid level
triglycerid level
Time frame: 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
Time frame: six months
Diet questionnaire
questionnaire
Time frame: six months
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Intercommunal Creteil