Clinical trial NCT02874859: Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema
Official title: Aflibercept Injection for Treatment of Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Keywords: DIABETIC RETINOPATHY
Intravitreal aflibercept
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2016-08-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past

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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)
timeFrame: 96 weeks
Secondary outcomes:
measure: Measure of the central macular thickness
timeFrame: 96 weeks
measure: Quantification of number of Aflibercept injections received
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Amiens
country: France
facility: Pr MILAZZO Solange
state: Hauts De France
city: Lomme
country: France
facility: Tran Thi Ha Chau
state: Hauts De France
city: Paris
country: France
facility: Bénédicte DUPAS
state: Ile De France
city: Nice
country: France
facility: Stéphanie BAILLIF
state: Paca
city: Bordeaux
country: France
facility: Dr DOMINGUEZ
city: Lyon
country: France
facility: Pr KODJIKIAN
city: Nantes
country: France
facility: Dr Franck BECQUET
city: Rouen
country: France
facility: Dr UZZAN
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Thi Ha Chau TRAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran THC, Erginay A, Verdun S, Fourmaux E, Le Rouic JF, Uzzan J, Milazzo S, Baillif S, Kodjikian L. One-Year Outcome of Aflibercept Intravitreal Injection in Vitrectomized Eyes with Diabetic Macular Edema. Clin Ophthalmol. 2021 May 11;15:1971-1978. doi: 10.2147/OPTH.S304030. eCollection 2021.