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

Diabetic Macular Edema Clinical Trial

— MODEVA  

Official title:

Aflibercept Injection for Treatment of Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874859
• Other study ID #: RC-P0051
• Status: Completed
• Start date: November 9, 2016
• Est. completion date: August 19, 2020

Study information

• Verified date: February 2021
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 19, 2020
• Est. primary completion date: August 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Locations

Country	Name	City	State
France	Pr MILAZZO Solange	Amiens	Hauts De France
France	Dr DOMINGUEZ	Bordeaux
France	Tran Thi Ha Chau	Lomme	Hauts De France
France	Pr KODJIKIAN	Lyon
France	Dr Franck BECQUET	Nantes
France	Stéphanie BAILLIF	Nice	Paca
France	Bénédicte DUPAS	Paris	Ile De France
France	Dr UZZAN	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
Lille Catholic University	Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)	Estimation of visual acuity after 96 weeks of treatment with Aflibercept	96 weeks
Secondary	Measure of the central macular thickness	Describe the evolution of the Central macular thickness during treatment	96 weeks
Secondary	Quantification of number of Aflibercept injections received		96 weeks