Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema

Lille Catholic University49 enrolled

Overview

This a non-interventional retrospective study on the efficiency and the tolerance of intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema

Diabetic macular edema (DME) is the leading cause of blindness among people of working age. Treatment of DME included blood pressure and glycemic control, grid laser, intravitreal injection of steroids (acetonide of triamcinolone, dexamethasone implant, fluocinolone implant) or anti-Vascular endothelial growth factor (VEGF) therapy (Bevacizumab, Ranibizumab, Aflibercept) (2015). The advent of anti-VEGF therapy has revolutionized the management of DME. Aflibercept, one of the drugs in this group has recently been approved in France. However, there is no report in the efficacy and tolerance of Aflibercept in vitrectomized eyes in the diabetic macular oedema . In this study, in order to prove the efficiency and tolerance of Aflibercept, data will be collected in a anonymous way in medical records of patients having received a treatment by Aflibercept in the past.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetic Macular Edema

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diabetic patients aged between 19 and 90 years old * Patients with the following characteristics at the beginning of the Aflibercept therapy : HbA1c \< 9% Diabetic macular oedema with the central affected Visual acuity between 1/20 and 5/40 (between 20 and 70 letters ETRS) Patients who had a vitrectomy over 3 months ago * Patients who did not received an anti-VEGF treatment or any other treatment for their diabetic macular edema 3 months before the beginning of the injections Exclusion Criteria: * Patients who refused the collection of their data in medical records * Patients with a macular ischemia of more than 1500µm diagnosed via an avascular central fluorescein angiography before the inclusion * Patients with a recent cardiovascular incident (heart attack, stroke dating for less than 3 months before the inclusion) * Pregnancy at the moment of inclusion

Locations (8)

Pr MILAZZO Solange

Amiens, Hauts-de-France, France

Tran Thi Ha Chau

Lomme, Hauts-de-France, France

Stéphanie BAILLIF

Nice, PACA, France

Dr DOMINGUEZ

Bordeaux, France

Outcomes

Primary Outcomes

Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)

Estimation of visual acuity after 96 weeks of treatment with Aflibercept

Time frame: 96 weeks

Secondary Outcomes

Measure of the central macular thickness

Describe the evolution of the Central macular thickness during treatment

Time frame: 96 weeks

Quantification of number of Aflibercept injections received

Time frame: 96 weeks

Data from ClinicalTrials.gov

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