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

NCT03783832 | Unknown

• 1 other identifier: 2017-A03478-45
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (3)

• Quantitative data from OCT angiography

  The macular perfusion measurement with Foveal Avascular Zone assessment (area in mm2, boundary in mm, circularity in %) measured by OCT angiography

  1 Year

• Quantitative data from OCT angiography

  The perfusion density assessment (%) measured by OCT angiography

  1 Year

• Quantitative data from OCT angiography

  The vascular density assessment (%) measured by OCT angiography

  1 Year

Interventions

OCT ANGIOGRAPHY DATA OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Diabetic Macular Edema

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Aquitania Opthalmologica: lead

Study Sites (6)

CHU Bordeaux

Bordeaux, France

RECRUITING

CHU Dijon

Dijon, France

RECRUITING

Hôpital de la Croix-Rousse

Lyon, France

RECRUITING

CHU Nantes

Nantes, France

RECRUITING

CHU Nice

Nice, France

RECRUITING

CHU Strasbourg

Strasbourg, France

RECRUITING

Central Study Contacts

KOROBELNIK

CONTACT

33 5 57 82 12 16; jean-francois.korobelnik@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 21, 2018
• Study Start: June 19, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

FR (6)