Clinical trial NCT04499820: Effect of OMEGA3 Supplementation in Diabetic Retinopathy
Official title: Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Laboratoires Thea
First posted: 2020-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: density of the deep capillary plexus in optical coherence tomography angiography (OCTA)
timeFrame: six months
Secondary outcomes:
measure: capillary plexus density in OCTA
timeFrame: six months
measure: area (mm²) of the central avascular zone in OCTA
timeFrame: six months
measure: Visual acuity measurement ETDRS
timeFrame: six months
measure: Stage of diabetic retinopathy: minimal, moderate or severe
timeFrame: six months
measure: central retinal thickness (µm) in the 2 groups at 6 months
timeFrame: six months
measure: cholesterol level: Low-density lipoprotein, High-density lipoprotein and total cholesterol
timeFrame: six months
measure: triglycerid level
timeFrame: six months
measure: glycated haemoglobin (percent)
timeFrame: six months
measure: Diet questionnaire
timeFrame: six months
Other outcomes:
Locations:
city: Créteil
country: France
facility: CHI Creteil
state: Creteil
Study officials:
References: