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

Diabetic Macular Edema Clinical Trial

— DOCTA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03783832
• Other study ID #: 2017-A03478-45
• Status: Recruiting
• Start date: June 19, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2018
• Source: Aquitania Opthalmologica
• Contact: KOROBELNIK
• Phone: 33 5 57 82 12 16
• Email: jean-francois.korobelnik[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

• Patients showing a visual lost due to a diabetic macular edema (DME) in the central region and not for another reason, assessed by the investigateur. The visual acuity of the fellow eye is not an 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.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Other:
• OCT ANGIOGRAPHY DATA
Follow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	CHU Dijon	Dijon
France	Hôpital de la Croix-Rousse	Lyon
France	CHU Nantes	Nantes
France	CHU Nice	Nice
France	CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Aquitania Opthalmologica

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Quantitative data from OCT angiography	The perfusion density assessment (%) measured by OCT angiography	1 Year
Primary	Quantitative data from OCT angiography	The vascular density assessment (%) measured by OCT angiography	1 Year