Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT05309135
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2022-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy in Subjects With Corneal Edema Secondary to 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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Within the treated groups, the sponsor, investigator, assessor, and subject will be masked to the assigned dose.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-24', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of Treatment Emergent Ocular Adverse Events (TEAEs)', 'timeFrame': '12 months'}, {'measure': 'Incidence and severity of non-ocular TEAEs', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Central Corneal Thickness (CCT) as measured by pachymetry', 'timeFrame': '12 months'}, {'measure': 'Change from baseline in Best-Corrected Visual Acuity (BCVA) as measured by LogMAR score', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Corneal Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety of a fixed dose of human corneal endothelial cells when administered with varying concentrations of Rho kinase inhibitor (Y-27632) in patients with corneal edema secondary to endothelial dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated by subject or legal guardian), and any authorizations required by local law and be able to comply with all study requirements\n2. Clinical diagnosis of corneal edema secondary to endothelial dysfunction\n3. Best Corrected Visual Acuity (BCVA) no worse than 20/800 ETDRS (1.6 LogMAR) or better than 20/63 (0.5 LogMAR) in the study eye\n\nKey Exclusion Criteria:\n\n1. Keratoconus or other conditions of corneal thinning/ectasia\n2. Progressive stromal or anterior corneal dystrophies\n3. Pre-operative corneal epithelial, sub-epithelial or stromal staining, 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 with HCEC-1\n4. Prior ophthalmic surgery including cataract surgery except as noted above in Inclusion Criterion #4, corneal transplantation, glaucoma (MIGS, iridectomy, trabeculectomy, valve), or vitreo-retinal surgery, aphakia, anterior chamber-IOL or iris claw IOL, multifocal IOL.\n5. Relative Afferent Pupillary Defect (RAPD) in the study eye\n6. Uncontrolled glaucoma or an IOP greater than 24 mmHg that is not controlled with topical beta blockers alone at the time of the Screening Visit.'}, 'identificationModule': {'nctId': 'NCT05309135', 'acronym': 'Escalon', 'briefTitle': 'A Safety and Efficacy Study of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy in Subjects With Corneal Edema Secondary to Endothelial Dysfunction', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aurion Biotech'}, 'officialTitle': 'A Phase 1, Double-Masked, Randomized, Safety and Efficacy, Single Center Clinical Evaluation of Corneal Injection for Endothelial Dysfunction Using Human Corneal Endothelial Cell Therapy (HCEC-1) in Adult Subjects With Corneal Edema Secondary to Endothelial Dysfunction', 'orgStudyIdInfo': {'id': 'AB-HCEC-1-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose Rho kinase inhibitor Y-27632', 'description': 'Low dose Rho kinase inhibitor Y-27632', 'interventionNames': ['Drug: HCEC-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mid dose Rho kinase inhibitor Y-27632', 'description': 'Mid dose Rho kinase inhibitor Y-27632', 'interventionNames': ['Drug: HCEC-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'High dose Rho kinase inhibitor Y-27632', 'description': 'High dose Rho kinase inhibitor Y-27632', 'interventionNames': ['Drug: HCEC-1']}], 'interventions': [{'name': 'HCEC-1', 'type': 'DRUG', 'description': 'HCEC-1 = human cultured corneal endothelial cells and Rho kinase Y-27632 inhibitor', 'armGroupLabels': ['High dose Rho kinase inhibitor Y-27632', 'Low dose Rho kinase inhibitor Y-27632', 'Mid dose Rho kinase inhibitor Y-27632']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Salvador', 'country': 'El Salvador', 'facility': 'Site', 'geoPoint': {'lat': 13.68935, 'lon': -89.18718}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study plan and protocol will be shared with the study center and other researchers per request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aurion Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}