Status:
COMPLETED
Effect of OMEGA3 Supplementation in Diabetic Retinopathy
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Collaborating Sponsors:
Laboratoires Thea
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
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 m...
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, whi...
Eligibility Criteria
Inclusion
- ≥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
- \< 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.
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04499820
Start Date
June 26 2020
End Date
April 17 2025
Last Update
December 4 2025
Active Locations (1)
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1
CHI Creteil
Créteil, Creteil, France, 94000