Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-04-02 @ 10:27 AM
Study NCT ID:
NCT03783832
Status:
UNKNOWN
Last Update Posted:
2018-12-21
First Post:
2018-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2018-12-19', 'studyFirstSubmitQcDate': '2018-12-20', 'lastUpdatePostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative data from OCT angiography', 'timeFrame': '1 Year', 'description': 'The macular perfusion measurement with Foveal Avascular Zone assessment (area in mm2, boundary in mm, circularity in %) measured by OCT angiography'}, {'measure': 'Quantitative data from OCT angiography', 'timeFrame': '1 Year', 'description': 'The perfusion density assessment (%) measured by OCT angiography'}, {'measure': 'Quantitative data from OCT angiography', 'timeFrame': '1 Year', 'description': 'The vascular density assessment (%) measured by OCT angiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Diabetic Macular Edema', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potential (hormonal or any intrauterine devices).\n* 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).\n* Patients with diabetes treatment unchanged within the last 3 months prior to initial visit (First EYLEA® injection).\n* 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.\n* Patient to whom a treatment by aflibercept is indicated and OCT-angiography is performed at each injection visit.\n* Patients affiliated to social security system.\n* 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.\n\nNon iclusion Criteria:\n\n* Treatment with an anti VEGF (EYLEA®, LUCENTIS® or AVASTIN®) administrated by intravitreal injection within 3 months prior to initial visit in the study eye\n* Treatment with Ozurdex® administrated by intravitreal injection within 6 months prior to initial visit (First EYLEA® injection) in the study eye\n* History of or active ocular /intraocular inflammation (Uveitis) at initial visit (First EYLEA® injection), in either eye\n* Intra-ocular pressure ≥ 25 mmHg\n* Patient with neocascular glaucoma history\n* Patient with foveolar exsudat that interfere with images analysis.\n* History or current evidence of hypersentivity to mydriatic eye drops\n* Vitreomacular traction in the study eye\n* Panretinal coagulation within 3 months prior to initial visit (First EYLEA® injection), in the study eye.\n* Cataract surgery in the study eye within the 6 months prior to initial visit (First EYLEA® injection)\n* History of vitretectomy in the study eye\n* Treatment with systemic anti VEGF medications for cancer\n* 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)\n* Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account\n* Participation in any investigational study with exclusion period in progress at the initial visit (First EYLEA® injection)\n* Patients under guardianship\n* Pregnant or breastfeeding woman.'}, 'identificationModule': {'nctId': 'NCT03783832', 'acronym': 'DOCTA', 'briefTitle': 'Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Aquitania Opthalmologica'}, 'officialTitle': 'Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography', 'orgStudyIdInfo': {'id': '2017-A03478-45'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OCT ANGIOGRAPHY DATA', 'type': 'OTHER', 'description': 'Follow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-François KOROBELNIK', 'role': 'CONTACT'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Catherine CREUZOT-GARCHER', 'role': 'CONTACT'}], 'facility': 'CHU Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent KODJIKIAN', 'role': 'CONTACT'}], 'facility': 'Hôpital de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Michel WEBER', 'role': 'CONTACT'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphanie BAILLIF', 'role': 'CONTACT'}], 'facility': 'CHU Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David GAUCHER', 'role': 'CONTACT'}], 'facility': 'CHU Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'KOROBELNIK', 'role': 'CONTACT', 'email': 'jean-francois.korobelnik@chu-bordeaux.fr', 'phone': '33 5 57 82 12 16'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aquitania Opthalmologica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}