Status:
UNKNOWN
Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography
Lead Sponsor:
Aquitania Opthalmologica
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
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®) th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03783832
Start Date
June 19 2018
End Date
December 31 2019
Last Update
December 21 2018
Active Locations (6)
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1
CHU Bordeaux
Bordeaux, France
2
CHU Dijon
Dijon, France
3
Hôpital de la Croix-Rousse
Lyon, France
4
CHU Nantes
Nantes, France