Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT04499820
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04499820
Study Brief:
Protocol Section:
NCT04499820