Clinical trial NCT03783832: Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography
Official title: Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema
Lead sponsor: Aquitania Opthalmologica
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Diabetic Macular Edema

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.


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.

Primary outcomes:
measure: Quantitative data from OCT angiography
timeFrame: 1 Year
measure: Quantitative data from OCT angiography
timeFrame: 1 Year
measure: Quantitative data from OCT angiography
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Dijon
country: France
facility: CHU Dijon
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Strasbourg
country: France
facility: CHU Strasbourg
Study officials:
References: