Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography
- Conditions
- Diabetic Macular Edema
- Registration Number
- NCT03783832
- Lead Sponsor
- Aquitania Opthalmologica
- Brief Summary
This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 48
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantitative data from OCT angiography 1 Year The vascular density assessment (%) measured by OCT angiography
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
CHU Dijon
🇫🇷Dijon, France
CHU Bordeaux
🇫🇷Bordeaux, France
CHU Nantes
🇫🇷Nantes, France
CHU Strasbourg
🇫🇷Strasbourg, France
Hôpital de la Croix-Rousse
🇫🇷Lyon, France
CHU Nice
🇫🇷Nice, France