Informations générales (source: ClinicalTrials.gov)
Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography (DOCTA)
Observational
Aquitania Opthalmologica (Voir sur ClinicalTrials)
juin 2018
décembre 2019
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Dijon - Dijon - France | Catherine CREUZOT-GARCHER | Contact (sur clinicalTrials) | |||
| CHU Strasbourg - Strasbourg - France | David GAUCHER | Contact (sur clinicalTrials) | |||
| Hôpital de la Croix-Rousse - Lyon - France | Laurent KODJIKIAN | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Bordeaux - Bordeaux - France | Jean-François KOROBELNIK | Contact (sur clinicalTrials) | |||
| CHU Nantes - Nantes - France | Michel WEBER | Contact (sur clinicalTrials) | |||
| CHU Nice - Nice - France | Stéphanie BAILLIF | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.