Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT06630169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015715', 'term': 'Corneal Edema'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2024-10-04', 'studyFirstSubmitQcDate': '2024-10-04', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BCVA - 15-letter improvement (3-line gain)', 'timeFrame': 'Month 6', 'description': 'Response, defined as a ≥15-letter improvement (3-line gain) from baseline in best-corrected visual acuity (BCVA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and efficacy of cryopreserved AURN001 in patients with corneal edema secondary to endothelial dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)\n* BCVA no worse than 5 ETDRS letters (i.e., 1.6 LogMAR or approximate 20/800 Snellen equivalent).\n\nExclusion Criteria:\n\n* Have pre-operative corneal epithelial, sub-epithelial or stromal scarring or other opacity that is paracentral/central and visually significant, but not suspected to be secondary to corneal endothelial disease with the potential to improve from treatment in the study eye\n* Have history or presence of an ocular disease other than corneal endothelial dysfunction that could affect vision or safety assessments'}, 'identificationModule': {'nctId': 'NCT06630169', 'briefTitle': 'Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aurion Biotech'}, 'officialTitle': 'APANECA: A Prospective, Parallel-arm, Multi-Surgeon Study of Cryopreserved AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (2024-E002-C)', 'orgStudyIdInfo': {'id': 'APANECA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm 1', 'description': 'Endothelial polishing zone 1 (low)', 'interventionNames': ['Combination Product: Cryopreserved AURN001']}, {'type': 'OTHER', 'label': 'Arm 2', 'description': 'Endothelial polishing zone 2 (medium)', 'interventionNames': ['Combination Product: Cryopreserved AURN001']}, {'type': 'OTHER', 'label': 'Arm 3', 'description': 'Endothelial polishing zone 3 (high)', 'interventionNames': ['Combination Product: Cryopreserved AURN001']}], 'interventions': [{'name': 'Cryopreserved AURN001', 'type': 'COMBINATION_PRODUCT', 'description': 'Corneal Endothelial Cells and Y27632', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Salvador', 'country': 'El Salvador', 'facility': 'Aurion Biotech site', 'geoPoint': {'lat': 13.68935, 'lon': -89.18718}}], 'overallOfficials': [{'name': 'Study Manager, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aurion Biotech'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aurion Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}