Informations générales (source: ClinicalTrials.gov)
Effet d'Une supplémentation Par OMEGA3 Dans la rétinopathie diabétique (OMEDIA)
Interventional
N/A
Centre Hospitalier Intercommunal Creteil (Voir sur ClinicalTrials)
juin 2020
novembre 2024
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Eric SOUIED, MDH | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- ≥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
- < 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.