Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-27 @ 3:03 AM
Study NCT ID:
NCT01736592
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-12
First Post:
2012-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080362', 'term': 'Stargardt Disease'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2033-08-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-09', 'studyFirstSubmitDate': '2012-11-26', 'studyFirstSubmitQcDate': '2012-11-28', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2033-08-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of Adverse Events', 'timeFrame': '15 years', 'description': 'The number and percentage of patients with treatment emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Clinically important changes in ocular safety assessments', 'timeFrame': 'baseline to 15 years', 'description': 'From baseline in (TDU13583) study and from the last visit best-corrected visual acuity (BCVA), slit-lamp examination, Fundososcopy, intraocular pressure, laboratory parameters, concomitant medications'}, {'measure': 'Delay in retinal degeneration', 'timeFrame': 'baseline to 15 years', 'description': 'Measured as change from baseline in function relative to untreated contralateral eye on: BCVA, static perimetry, microperimetry, autofluorescence, optical coherence tomography (OCT)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ["Stargardt's Disease"]}, 'descriptionModule': {'briefSummary': "Primary Objective:\n\nTo evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration.\n\nSecondary Objective:\n\nTo assess:\n\n* Safety\n* Biological activity", 'detailedDescription': 'Patients will be followed for 15 years after completion/early termination from the previous TDU13583 study (NCT01367444).\n\nAs the initial TDU13583 study is terminated - recruitment to this LTS13588 study is over with 27 patients enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet ALL of the following criteria:\n\n1. Provide signed and dated written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act \\[HIPAA\\])\n2. Must have been enrolled in protocol TDU13583 (SG1/001/10)\n3. Must have received a subretinal injection of SAR422459\n4. Must have completed protocol TDU13583 to Week 48 or undergone an early discontinuation visit.\n\nExclusion Criteria:\n\nThe following would exclude Patients from participation in the study:\n\n1\\. Did not receive SAR422459 as part of the TDU13583 protocol.'}, 'identificationModule': {'nctId': 'NCT01736592', 'briefTitle': "Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': "An Open Label Study to Determine the Long Term Safety, Tolerability and Biological Activity of SAR422459 in Patients With Stargardt's Macular Degeneration", 'orgStudyIdInfo': {'id': 'LTS13588'}, 'secondaryIdInfos': [{'id': 'SG1/002/11', 'type': 'OTHER', 'domain': 'Sanofi Identifier'}, {'id': '2024-513501-31', 'type': 'REGISTRY', 'domain': 'CTIS'}, {'id': '2012-001990-95', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Long Term Follow up', 'description': 'Long term follow up in all patients who received SAR422459 in previous study TDU13583', 'interventionNames': ['Drug: Long term follow up in all patients who received SAR422459 in previous study TDU13583']}], 'interventions': [{'name': 'Long term follow up in all patients who received SAR422459 in previous study TDU13583', 'type': 'DRUG', 'description': 'Blood draw for the laboratory assessment', 'armGroupLabels': ['Long Term Follow up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University Site Number : 840001', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Investigational Site Number : 250001', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}