Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography (DOCTA)

Aquitania Opthalmologica

Status: Unknown

Conditions: Diabetic Macular Edema

Treatments: Other: OCT ANGIOGRAPHY DATA

Study type: Observational

Funder types: Other

Identifiers

NCT03783832

2017-A03478-45

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.