Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:53 AM
Study NCT ID:
NCT07368959
Status:
RECRUITING
Last Update Posted:
2026-03-20
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015715', 'term': 'Corneal Edema'}], 'ancestors': [{'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108830', 'term': 'Y 27632'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants who achieve a ≥ 15-letter improvement (3-line gain) from baseline in Best Corrected Visual Acuity (BCVA) at Month 6', 'timeFrame': 'At Month 6'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in non-contact Central Corneal Thickness (CCT) at Month 6', 'timeFrame': 'Baseline (Day 1) and At Month 6'}, {'measure': 'Change from baseline in BCVA at Month 6', 'timeFrame': 'Baseline (Day 1) and At Month 6'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Best Corrected Visual Acuity', 'Central corneal thickness', 'Human Corneal Endothelial Cells', 'Neltependocel', 'Postsurgical endothelial dysfunction', 'Keratoplasty', 'Pseudophakic Corneal Edema (PCE)', 'Corneal Endothelial Cells', 'Endothelial Cells', 'AURN001', 'Y-27632', 'Endothelial Keratoplasty', 'Corneal Endothelial Cell Therapy'], 'conditions': ['Corneal Edema', 'Corneal Endothelial Dysfunction', 'Fuchs Endothelial Corneal Dysfunction', 'Pseudophakic Bullous Keratopathy (PBK)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of single injection dose of AURN001 compared with placebo in adult participants with corneal edema secondary to corneal endothelial dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Ocular Inclusion Criteria:\n\n(All ocular criteria apply to the study eye unless noted otherwise)\n\n* Have corneal edema secondary to corneal endothelial dysfunction, requiring surgery (full- or partial-thickness endothelial keratoplasty)\n* BCVA between 65 ETDRS letters (approximate 20/50 Snellen equivalent) and 5 ETDRS letters (approximate 20/800 Snellen equivalent)\n* Be pseudophakic with PCIOL\n\nKey Ocular Exclusion Criteria:\n\n(All ocular criteria apply to the study eye unless noted otherwise)\n\n* Have progressive corneal dystrophies or degenerations\n* Have visually significant corneal or other ocular pathologies\n\nOther inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07368959', 'briefTitle': 'AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aurion Biotech'}, 'officialTitle': 'ASTRA: A Phase 3 Multi-center, Randomized, Double-Masked, Prospective Study of AURN001 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction (ABA-3)', 'orgStudyIdInfo': {'id': 'ABA-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AURN001', 'description': 'Participants will receive single dose of AURN001', 'interventionNames': ['Drug: Combination Product: AURN001 + Y-27632']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive single dose of placebo control.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Combination Product: AURN001 + Y-27632', 'type': 'DRUG', 'description': 'AURN001 will be injected to the anterior chamber of the eye.', 'armGroupLabels': ['AURN001']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo control will be injected to the anterior chamber of the eye.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 2', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 6', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 9', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '30339', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 7', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '64154', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 4', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '28451', 'city': 'Leland', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 11', 'geoPoint': {'lat': 34.25628, 'lon': -78.04471}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 5', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '19004', 'city': 'Cynwyd', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 3', 'geoPoint': {'lat': 40.0109, 'lon': -75.23}}, {'zip': '19462', 'city': 'Plymouth Meeting', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 10', 'geoPoint': {'lat': 40.10233, 'lon': -75.27435}}, {'zip': '29456', 'city': 'Ladson', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 12', 'geoPoint': {'lat': 32.98573, 'lon': -80.10981}}, {'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 8', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77388', 'city': 'Spring', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigational Site 1', 'geoPoint': {'lat': 30.07994, 'lon': -95.41716}}], 'centralContacts': [{'name': 'Aurion Study Team', 'role': 'CONTACT', 'email': 'ASTRA@aurionbiotech.com', 'phone': '1-857-639-4168'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aurion Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}