Diabetic Macular Edema
Conditions
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.
Interventions
OTHEROCT ANGIOGRAPHY DATA
Follow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography
Sponsors
Aquitania Opthalmologica
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative data from OCT angiography | 1 Year | The macular perfusion measurement with Foveal Avascular Zone assessment (area in mm2, boundary in mm, circularity in %) measured by OCT angiography |
Countries
France
Contacts
Primary ContactKOROBELNIK
Outcome results
None listed