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

February 2, 2021 updated by: Lille Catholic University

Aflibercept Injection for Treatment of Diabetic Macular Edema

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

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

49

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Dr DOMINGUEZ
      • Lyon, France, 69004
        • Pr KODJIKIAN
      • Nantes, France, 44300
        • Dr Franck BECQUET
      • Rouen, France, 76100
        • Dr UZZAN
    • Hauts De France
      • Amiens, Hauts De France, France, 80000
        • Pr MILAZZO Solange
      • Lomme, Hauts De France, France, 59160
        • Tran Thi Ha Chau
    • Ile De France
      • Paris, Ile De France, France, 75010
        • Bénédicte DUPAS
    • Paca
      • Nice, Paca, France, 06001
        • Stéphanie BAILLIF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)
Time Frame: 96 weeks
Estimation of visual acuity after 96 weeks of treatment with Aflibercept
96 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of the central macular thickness
Time Frame: 96 weeks
Describe the evolution of the Central macular thickness during treatment
96 weeks
Quantification of number of Aflibercept injections received
Time Frame: 96 weeks
96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lille Catholic University

Collaborators

Bayer

Investigators

  • Principal Investigator: Thi Ha Chau TRAN, PhD, Groupement des Hôpitaux de l'institut Catholique de Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2016

Primary Completion (Actual)

August 19, 2020

Study Completion (Actual)

August 19, 2020

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-P0051

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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