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

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ClinicalTrials.gov Identifier: NCT02874859
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
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

Condition or disease
Diabetic Macular Edema

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Aflibercept Injection for Treatment of Diabetic Macular Edema
Actual Study Start Date : November 9, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Aflibercept




Primary Outcome Measures :
  1. Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) [ Time Frame: 12 months ]
    Estimation of visual acuity after 56 weeks of treatment with Aflibercept


Secondary Outcome Measures :
  1. Measure of the central macular thickness [ Time Frame: 12 months ]
    Describe the evolution of the Central macular thickness during treatment

  2. Quantification of number of Aflibercept injections received [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874859


Contacts
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Contact: Amélie lansiaux, MD, PhD 00 33 3 20 22 52 69 lansiaux.amelie@ghicl.net
Contact: Marine DESEUR-PYTKOWSKI 00 33 3 20 22 57 01 Pytkowski.marine@ghicl.net

Locations
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France
Pr MILAZZO Solange Recruiting
Amiens, Hauts De France, France, 80000
Contact: Solange MILAZZO, PhD         
Tran Thi Ha Chau Recruiting
Lomme, Hauts De France, France, 59160
Contact: THI HA CHAU TRAN, MD         
Bénédicte DUPAS Recruiting
Paris, Ile De France, France, 75010
Contact: Bénédicte DUPAS, MD         
Stéphanie BAILLIF Recruiting
Nice, Paca, France, 06001
Contact: Stéphanie BAILLIF, PhD         
Sponsors and Collaborators
Lille Catholic University
Bayer
Investigators
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Principal Investigator: Thi Ha Chau TRAN, MD Groupement des Hôpitaux de l'Institut Catholique de Lille

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02874859     History of Changes
Other Study ID Numbers: RC-P0051
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lille Catholic University:
DIABETIC RETINOPATHY
Intravitreal aflibercept

Additional relevant MeSH terms:
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Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases