Effect of OMEGA3 Supplementation in Diabetic Retinopathy (OMEDIA)

Centre Hospitalier Intercommunal Creteil

Status: Enrolling

Conditions: Diabetic Retinopathy

Treatments: Dietary Supplement: Meralut; Dietary Supplement: Nutrof

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04499820

OMEDIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

NUTROF Group

Experimental group

Description:

vitamin and DHA supplementation

Treatment:

Dietary Supplement: Nutrof

MERALUT Group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Meralut