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Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography

NCT ID: NCT03783832

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-19

Study Completion Date

2019-12-31

Brief Summary

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This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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OCT ANGIOGRAPHY DATA

Follow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potential (hormonal or any intrauterine devices).
* Patients with type I or II diabetes (as defined by criteria of American diabetes association ADA or world health organization WHO) with an glycosylated hemoglobin rate (HbA1c) \< 10.0%, at initial visit (First EYLEA® injection).
* Patients with diabetes treatment unchanged within the last 3 months prior to initial visit (First EYLEA® injection).

Exclusion Criteria

* Patient to whom a treatment by aflibercept is indicated and OCT-angiography is performed at each injection visit.
* Patients affiliated to social security system.
* Patient who has been given appropriate information about the study objectives and instructions who has given his/her non-opposition prior to conduct any study-related procedures and examination.

Non iclusion Criteria:

* Treatment with an anti VEGF (EYLEA®, LUCENTIS® or AVASTIN®) administrated by intravitreal injection within 3 months prior to initial visit in the study eye
* Treatment with Ozurdex® administrated by intravitreal injection within 6 months prior to initial visit (First EYLEA® injection) in the study eye
* History of or active ocular /intraocular inflammation (Uveitis) at initial visit (First EYLEA® injection), in either eye
* Intra-ocular pressure ≥ 25 mmHg
* Patient with neocascular glaucoma history
* Patient with foveolar exsudat that interfere with images analysis.
* History or current evidence of hypersentivity to mydriatic eye drops
* Vitreomacular traction in the study eye
* Panretinal coagulation within 3 months prior to initial visit (First EYLEA® injection), in the study eye.
* Cataract surgery in the study eye within the 6 months prior to initial visit (First EYLEA® injection)
* History of vitretectomy in the study eye
* Treatment with systemic anti VEGF medications for cancer
* History of cerebrovascular accident within 3 months prior to initial visit (First EYLEA® injection), renal failure, uncontrolled arterial hypertension (PAS\>160 mm Hg and/ or PAD\>100 mm Hg)
* Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
* Participation in any investigational study with exclusion period in progress at the initial visit (First EYLEA® injection)
* Patients under guardianship
* Pregnant or breastfeeding woman.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aquitania Opthalmologica

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status RECRUITING

CHU Dijon

Dijon, , France

Site Status RECRUITING

Hôpital de la Croix-Rousse

Lyon, , France

Site Status RECRUITING

CHU Nantes

Nantes, , France

Site Status RECRUITING

CHU Nice

Nice, , France

Site Status RECRUITING

CHU Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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KOROBELNIK

Role: CONTACT

Phone: 33 5 57 82 12 16

Email: [email protected]

Facility Contacts

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Jean-François KOROBELNIK

Role: primary

Catherine CREUZOT-GARCHER

Role: primary

Laurent KODJIKIAN

Role: primary

Michel WEBER

Role: primary

Stéphanie BAILLIF

Role: primary

David GAUCHER

Role: primary

Other Identifiers

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2017-A03478-45

Identifier Type: -

Identifier Source: org_study_id