Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema
MODEVA
Aflibercept Injection for Treatment of Diabetic Macular Edema
1 other identifier
observational
49
1 country
8
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2016
CompletedFirst Posted
Study publicly available on registry
August 22, 2016
CompletedStudy Start
First participant enrolled
November 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2020
CompletedFebruary 5, 2021
February 1, 2021
3.8 years
August 17, 2016
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)
Estimation of visual acuity after 96 weeks of treatment with Aflibercept
96 weeks
Secondary Outcomes (2)
Measure of the central macular thickness
96 weeks
Quantification of number of Aflibercept injections received
96 weeks
Eligibility Criteria
Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past
You may qualify if:
- 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
You may not qualify if:
- Patients who refused the collection of their data in medical records
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lille Catholic Universitylead
- Bayercollaborator
Study Sites (8)
Pr MILAZZO Solange
Amiens, Hauts-de-France, 80000, France
Tran Thi Ha Chau
Lomme, Hauts-de-France, 59160, France
Stéphanie BAILLIF
Nice, PACA, 06001, France
Dr DOMINGUEZ
Bordeaux, 33000, France
Pr KODJIKIAN
Lyon, 69004, France
Dr Franck BECQUET
Nantes, 44300, France
Dr UZZAN
Rouen, 76100, France
Bénédicte DUPAS
Paris, Île-de-France Region, 75010, France
Related Publications (1)
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.
PMID: 34007150DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thi Ha Chau TRAN, PhD
Groupement des Hôpitaux de l'Institut Catholique de Lille
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2016
First Posted
August 22, 2016
Study Start
November 9, 2016
Primary Completion
August 19, 2020
Study Completion
August 19, 2020
Last Updated
February 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share