Effect of OMEGA3 Supplementation in Diabetic Retinopathy (OMEDIA)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Dietary supplement: Nutrof; Dietary supplement: Meralut

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric SOUIED, MD PhD; Phone Number: 01 45 17 50 00; Email: eric.souied@chicreteil.Fr
• Study Contact Backup: Name: Camille JUNG, MD; Phone Number: 01 45 17 50 00; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Creteil
    • Créteil, Creteil, France, 94000
      • Recruiting
      • CHI Creteil
      • Contact: Eric SOUIED, MDH; Phone Number: 33 01 45 17 52 22; Email: eric.souied@chicreteil.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥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

Exclusion Criteria:

• < 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-
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NUTROF Group; vitamin and DHA supplementation	Dietary supplement: Nutrof; DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.
Placebo Comparator: MERALUT Group; vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA	Dietary supplement: Meralut; vitamin A, natural flavonoids, lutein and zeaxanthin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
capillary plexus density in OCTA		six months
area (mm²) of the central avascular zone in OCTA		six months
Visual acuity measurement ETDRS		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)	six months
central retinal thickness (µm) in the 2 groups at 6 months		six months
cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol		six months
triglycerid level		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	six months
Diet questionnaire		six months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Laboratoires Thea

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2020
• Primary Completion (Anticipated): November 25, 2022
• Study Completion (Anticipated): November 25, 2022

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: OMEDIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No