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:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT03783832
Eligibility Criteria:
Inclusion Criteria:
* Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potential (hormonal or any intrauterine devices).
* Patients with type I or II diabetes (as defined by criteria of American diabetes association ADA or world health organization WHO) with an glycosylated hemoglobin rate (HbA1c) \< 10.0%, at initial visit (First EYLEA® injection).
* Patients with diabetes treatment unchanged within the last 3 months prior to initial visit (First EYLEA® injection).
* Patients showing a visual lost due to a diabetic macular edema (DME) in the central region and not for another reason, assessed by the investigateur. The visual acuity of the fellow eye is not an exclusion criteria.
* Patient to whom a treatment by aflibercept is indicated and OCT-angiography is performed at each injection visit.
* Patients affiliated to social security system.
* Patient who has been given appropriate information about the study objectives and instructions who has given his/her non-opposition prior to conduct any study-related procedures and examination.
Non iclusion Criteria:
* Treatment with an anti VEGF (EYLEA®, LUCENTIS® or AVASTIN®) administrated by intravitreal injection within 3 months prior to initial visit in the study eye
* Treatment with Ozurdex® administrated by intravitreal injection within 6 months prior to initial visit (First EYLEA® injection) in the study eye
* History of or active ocular /intraocular inflammation (Uveitis) at initial visit (First EYLEA® injection), in either eye
* Intra-ocular pressure ≥ 25 mmHg
* Patient with neocascular glaucoma history
* Patient with foveolar exsudat that interfere with images analysis.
* History or current evidence of hypersentivity to mydriatic eye drops
* Vitreomacular traction in the study eye
* Panretinal coagulation within 3 months prior to initial visit (First EYLEA® injection), in the study eye.
* Cataract surgery in the study eye within the 6 months prior to initial visit (First EYLEA® injection)
* History of vitretectomy in the study eye
* Treatment with systemic anti VEGF medications for cancer
* History of cerebrovascular accident within 3 months prior to initial visit (First EYLEA® injection), renal failure, uncontrolled arterial hypertension (PAS\>160 mm Hg and/ or PAD\>100 mm Hg)
* Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
* Participation in any investigational study with exclusion period in progress at the initial visit (First EYLEA® injection)
* Patients under guardianship
* Pregnant or breastfeeding woman.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03783832
Study Brief:
Protocol Section:
NCT03783832