Effect of OMEGA3 Supplementation in Diabetic Retinopathy

NCT04499820 | Completed

• 1 other identifier: OMEDIA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  six months

• central retinal thickness (µm) in the 2 groups at 6 months

  six months

Study Arms (2)

NUTROF Group

EXPERIMENTAL

vitamin and DHA supplementation

Dietary Supplement: Nutrof

MERALUT Group

PLACEBO COMPARATOR

vitamin A, natural flavonoids, lutein and zeaxanthin and no DHA

Dietary Supplement: Meralut

Interventions

Meralut DIETARY_SUPPLEMENT

vitamin A, natural flavonoids, lutein and zeaxanthin

MERALUT Group

Nutrof DIETARY_SUPPLEMENT

DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.

NUTROF Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Laboratoires Thea: collaborator
• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

CHI Creteil

Créteil, Creteil, 94000, France

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: August 5, 2020
• Study Start: June 26, 2020
• Primary Completion: October 10, 2024
• Study Completion: April 17, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)