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

Completed

• Conditions: Diabetic Macular Edema

• Registration Number: NCT02874859
• Lead Sponsor: Lille Catholic University

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2016-08-17
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-22
• Study Start: 2016-11-09
• Primary Completion: 2020-08-19
• Study Completion: 2020-08-19
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)	96 weeks	Estimation of visual acuity after 96 weeks of treatment with Aflibercept

Secondary Outcome Measures

Name	Time	Method
Measure of the central macular thickness	96 weeks	Describe the evolution of the Central macular thickness during treatment
Quantification of number of Aflibercept injections received	96 weeks

Trial Locations

Locations (8)

Tran Thi Ha Chau; 🇫🇷 Lomme, Hauts De France, France

Dr DOMINGUEZ; 🇫🇷 Bordeaux, France

Dr UZZAN; 🇫🇷 Rouen, France

Pr MILAZZO Solange; 🇫🇷 Amiens, Hauts De France, France

Bénédicte DUPAS; 🇫🇷 Paris, Ile De France, France

Stéphanie BAILLIF; 🇫🇷 Nice, Paca, France

Dr Franck BECQUET; 🇫🇷 Nantes, France

Pr KODJIKIAN; 🇫🇷 Lyon, France