Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-13 @ 1:50 AM
Study NCT ID:
NCT01998412
Status:
UNKNOWN
Last Update Posted:
2019-03-20
First Post:
2013-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Iluvien Registry Safety Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-22', 'releaseDate': '2022-01-19'}, {'resetDate': '2023-10-09', 'releaseDate': '2022-12-08'}], 'estimatedResultsFirstSubmitDate': '2022-01-19'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 559}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2013-11-20', 'studyFirstSubmitQcDate': '2013-11-24', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events.', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Diabetic Macular Oedema Considered Insufficiently Responsive to Available Therapies']}, 'referencesModule': {'references': [{'pmid': '30242062', 'type': 'RESULT', 'citation': 'Chakravarthy U, Taylor SR, Koch FHJ, Castro de Sousa JP, Bailey C; ILUVIEN Registry Safety Study (IRISS) Investigators Group. Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries. Br J Ophthalmol. 2019 Aug;103(8):1072-1077. doi: 10.1136/bjophthalmol-2018-312284. Epub 2018 Sep 21.'}], 'seeAlsoLinks': [{'url': 'http://dx.doi.org/10.1136/bjophthalmol-2018-312284', 'label': 'Changes in intraocular pressure after intravitreal fluocinolone acetonide (ILUVIEN): real-world experience in three European countries'}]}, 'descriptionModule': {'briefSummary': 'The study will include any patient treated with Iluvien at designated sites in European countries where marketing authorization has been granted in order to obtain broader safety and usage information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with vision impairment associated with chronic diabetic macular oedema considered insufficiently responsive to available therapies that were selected to be treated with an intravitreal implant of ILUVIEN.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient treated with Iluvien under this protocol will be included in the study.\n\nExclusion Criteria:\n\n* Patients/Guardians who are unable to understand and sign the Informed Consent will be excluded from the study.\n\nRetrospective Enrollment Criteria\n\nPatients treated with ILUVIEN prior to study initiation may be included provided they satisfy the inclusion and exclusion criteria, where applicable, as well as, the following requirements:\n\n1. The site is allowed to enroll a patient who was treated with ILUVIEN no more than 36 months prior to bringing the patient in for their first study visit.\n2. The eligible patient must meet the data requirements as specified in the protocol, i.e., baseline data collected within 7 days prior to treatment with ILUVIEN and additional data subsequently collected approximately every 6 months thereafter until enrolment into the study.\n3. The eligible patient must be enrolled at least one year prior to the planned end of the study.'}, 'identificationModule': {'nctId': 'NCT01998412', 'acronym': 'IRISS', 'briefTitle': 'Iluvien Registry Safety Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'ANI Pharmaceuticals'}, 'officialTitle': 'An Open Label, Registry Study of the Safety of Iluvien® 190 Micrograms Intravitreal Implant in Applicator', 'orgStudyIdInfo': {'id': 'M-01-12-001'}}, 'contactsLocationsModule': {'locations': [{'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alimera Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-01-19', 'type': 'RELEASE'}, {'date': '2022-03-22', 'type': 'RESET'}, {'date': '2022-12-08', 'type': 'RELEASE'}, {'date': '2023-10-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Alimera Sciences'}}}}