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Effect of OMEGA3 Supplementation in Diabetic Retinopathy

Effect of OMEGA3 Supplementation in Diabetic Retinopathy

Not Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Diabetic Retinopathy

NCT04499820

Centre Hospitalier Intercommunal Creteil

12 December 2025

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