Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 10:16 PM
Study NCT ID:
NCT06268561
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009877', 'term': 'Endophthalmitis'}], 'ancestors': [{'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2023-11-16', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '2018 to 2023', 'description': 'Evolution of visual acuity from the first to the last patient includes'}], 'secondaryOutcomes': [{'measure': 'IOP measured in mmHg by tonometer and confirmed with Goldman Applanation', 'timeFrame': '2018 to 2023', 'description': 'Changes intra ocular pressure.'}, {'measure': 'Tomography', 'timeFrame': '2018 to 2023', 'description': 'Changes in the outer retina on optical coherence tomography'}, {'measure': 'Resumption of intravitreal therapy', 'timeFrame': '2018 to 2023', 'description': 'Number of new intravitreal injections necessary to control the princeps pathology (AMD/OMD...) during the follow-up of the study ; i.e. relapse of activity of the princeps pathology'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['OZURDEX', 'Visual Acuity', 'Endophtalmitis'], 'conditions': ['Endophthalmitis']}, 'descriptionModule': {'briefSummary': 'OZURDEX endophthalmitis is a rare and potentially very serious pathology. Different treatments can be carried out early and change the functional prognosis of the patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who had endophtalmitis following an OZURDEX implant injection within 2 months\n\nExclusion Criteria:\n\n* Intra oculaire procedure in the interval between the injection of OZURDEX and endophtalmitis'}, 'identificationModule': {'nctId': 'NCT06268561', 'briefTitle': 'Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Ozurdex Endophtamitis Cohort, Prognostic Assessment at 12 Months', 'orgStudyIdInfo': {'id': 'IRBN852023/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OZURDEX patients', 'description': 'Patients treated by Dr Garcin and Pr Thuret CHU of Saint Etienne in the context of post-OZURDEX endophthalmitis', 'interventionNames': ['Other: Visual acuity analysis', 'Other: Intraocular pressure analysis', 'Other: Analysis of optical coherence tomography (OCT) images', 'Other: Analysis of retinograms']}], 'interventions': [{'name': 'Visual acuity analysis', 'type': 'OTHER', 'description': 'Collection of information on visual acuity from the medical file concerning the surgery', 'armGroupLabels': ['OZURDEX patients']}, {'name': 'Intraocular pressure analysis', 'type': 'OTHER', 'description': 'Collection of information on intraocular pressure from the medical file concerning the surgery', 'armGroupLabels': ['OZURDEX patients']}, {'name': 'Analysis of optical coherence tomography (OCT) images', 'type': 'OTHER', 'description': 'Collection and analysis of optical coherence tomography (OCT) images of the medical file concerning the surgery', 'armGroupLabels': ['OZURDEX patients']}, {'name': 'Analysis of retinograms', 'type': 'OTHER', 'description': 'Collection and analysis of retinography images of the medical file concerning the surgery', 'armGroupLabels': ['OZURDEX patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Thibaud GARCIN, MD PhD', 'role': 'CONTACT', 'email': 'thibaud.garcin@chu-st-etienne.fr', 'phone': '(0)477829662', 'phoneExt': '+33'}, {'name': 'Thibaud GARCIN, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Henri PITEAU, resident', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'centralContacts': [{'name': 'Thibaud GARCIN, MD PhD', 'role': 'CONTACT', 'email': 'thibaud.garcin@chu-st-etienne.fr', 'phone': '(0)477829662', 'phoneExt': '+33'}, {'name': 'Henri PITEAU, resident', 'role': 'CONTACT', 'email': 'piteau.henri@gmail.com', 'phone': '(0)477829662', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Thibaud GARCIN, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}