Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-22 @ 6:47 PM
Study NCT ID:
NCT02089503
Status:
UNKNOWN
Last Update Posted:
2014-03-18
First Post:
2014-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monocentric Retrospective Observational Study on Patients With Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-07-14', 'releaseDate': '2015-06-18'}, {'resetDate': '2016-02-03', 'releaseDate': '2016-01-05'}, {'resetDate': '2018-11-23', 'releaseDate': '2018-05-09'}], 'estimatedResultsFirstSubmitDate': '2015-06-18'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-03-17', 'studyFirstSubmitDate': '2014-03-14', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2014-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).', 'timeFrame': 'measured at 24 months (± 4 weeks)'}], 'secondaryOutcomes': [{'measure': 'the mean change of the BCVA throughout the 24 months of follow-up (FU),', 'timeFrame': '24 months of follow-up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Exudative Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with exudative-subfove ARMD, regardless the neovessel type or the initial visual acuity; 2 - Patients treated in the department with intra vitreous injection of Lucentis ® during the study period (08/2011 and 02/2013); 3 - If both eyes are eligible, both will be analyzed;\n\nExclusion Criteria:\n\n1. \\- Patients who received, for the studied eye, a treatment with a Vascular endothelial growth factor (VEGF) other than Lucentis ® in the three months preceding the start of the study. For those who received combination therapy, the nature of the treatment will be specified and taken into account in the subgroups for statistical analyzes;\n2. \\- Patients with high myopia or neovessel not related to exudative-ARMD;'}, 'identificationModule': {'nctId': 'NCT02089503', 'acronym': 'ELOUAN', 'briefTitle': 'Monocentric Retrospective Observational Study on Patients With Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Hospital St. Joseph, Marseille, France'}, 'officialTitle': 'Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.', 'orgStudyIdInfo': {'id': 'ELOUAN HSJ 2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'induction phase + intravitreal inj.', 'description': 'Group of patients who received Lucentis ® with induction phase', 'interventionNames': ['Other: intravitreal injections of Lucentis']}, {'label': 'intravitreal inj. without induction', 'description': 'Group of patients who received Lucentis ® without induction phase', 'interventionNames': ['Other: intravitreal injections of Lucentis']}, {'label': 'intravitreal inj. + monthly follow-up', 'description': 'group of patients who were monthly monitored (+/- 1 week)', 'interventionNames': ['Other: intravitreal injections of Lucentis']}, {'label': 'intravitreal inj. + follow-up :> 1 month', 'description': 'group of patients with Follow up visits intervals\\> 1 month (+/- 1 week)', 'interventionNames': ['Other: intravitreal injections of Lucentis']}, {'label': 'intravitreal inj +induction+ month. FU', 'description': 'Group of patients who received Lucentis with induction phase and who were monthly monitored (+/- 1 week)', 'interventionNames': ['Other: intravitreal injections of Lucentis']}, {'label': 'date Lucentis® 1st intravitreal Inj.', 'description': 'Group of patients selected in accordance with the date of Lucentis® treatment start.', 'interventionNames': ['Other: intravitreal injections of Lucentis']}], 'interventions': [{'name': 'intravitreal injections of Lucentis', 'type': 'OTHER', 'description': 'intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use', 'armGroupLabels': ['date Lucentis® 1st intravitreal Inj.', 'induction phase + intravitreal inj.', 'intravitreal inj +induction+ month. FU', 'intravitreal inj. + follow-up :> 1 month', 'intravitreal inj. + monthly follow-up', 'intravitreal inj. without induction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13008', 'city': 'Marseille', 'country': 'France', 'contacts': [{'name': 'Frederic QUEGUINER, MD', 'role': 'CONTACT'}, {'name': 'Frederic QUEGUINER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hopital Saint Joseph', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Frederic QUEGUINER, MD', 'role': 'CONTACT', 'email': 'fqueguiner@hopital-saint-joseph.fr', 'phone': '+33491806793'}], 'overallOfficials': [{'name': 'Maud RIGHINI, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HSJ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital St. Joseph, Marseille, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ophtalmologist', 'investigatorFullName': 'QUEGUINER, MD', 'investigatorAffiliation': 'Hospital St. Joseph, Marseille, France'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-06-18', 'type': 'RELEASE'}, {'date': '2015-07-14', 'type': 'RESET'}, {'date': '2016-01-05', 'type': 'RELEASE'}, {'date': '2016-02-03', 'type': 'RESET'}, {'date': '2018-05-09', 'type': 'RELEASE'}, {'date': '2018-11-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Frédéric QUEGUINER, MD, Ophtalmologist, Hospital St. Joseph, Marseille, France'}}}}