Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT05587205
Status:
RECRUITING
Last Update Posted:
2025-12-08
First Post:
2022-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of EO2002
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002386', 'term': 'Cataract'}, {'id': 'D055954', 'term': 'Corneal Endothelial Cell Loss'}], 'ancestors': [{'id': 'D007905', 'term': 'Lens Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C005703', 'term': 'salicylhydroxamic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '2 arms are masked as indicated and 2 arms are open label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2022-10-17', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of EO2002', 'timeFrame': '26 weeks', 'description': 'Incidence of Treatment-Emergent Adverse Events'}], 'secondaryOutcomes': [{'measure': 'Endothelial Cell Density', 'timeFrame': '26 weeks', 'description': 'Changes in ECD compared to baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cataract', 'Endothelial Cell Loss, Corneal']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery.\n3. Decreased endothelial cell count\n\nExclusion Criteria:\n\nAll ocular criteria apply to study eye unless otherwise noted.\n\n1. Other corneal disease\n2. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.\n3. Descemet membrane detachment.\n4. History of uveitis or other ocular inflammatory disease.\n5. History of incisional glaucoma surgery\n6. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.\n7. History of ocular neoplasm.\n8. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).\n9. Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.\n10. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.\n11. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator."}, 'identificationModule': {'nctId': 'NCT05587205', 'briefTitle': 'Safety and Tolerability of EO2002', 'organization': {'class': 'OTHER', 'fullName': 'Asociación para Evitar la Ceguera en México'}, 'officialTitle': 'Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery', 'orgStudyIdInfo': {'id': 'VSH-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment at time of surgery', 'description': 'EO2002 intracameral injection', 'interventionNames': ['Biological: EO2002']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment post surgery', 'description': 'EO2002 intracameral injection', 'interventionNames': ['Biological: EO2002']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment at time of or post surgery', 'description': 'EO2002 intracameral injection', 'interventionNames': ['Biological: EO2002']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham injection at time of or post surgery', 'description': 'Sham injection', 'interventionNames': ['Other: Sham injection']}], 'interventions': [{'name': 'EO2002', 'type': 'BIOLOGICAL', 'otherNames': ['Magnetic Human Corneal Endothelial Cells'], 'description': 'Intracameral injection of a single dose of magnetic human corneal endothelial cells (EO2002) either at the time of cataract surgery or post-cataract surgery', 'armGroupLabels': ['Treatment at time of or post surgery', 'Treatment at time of surgery', 'Treatment post surgery']}, {'name': 'Sham injection', 'type': 'OTHER', 'description': 'Sham injection', 'armGroupLabels': ['Sham injection at time of or post surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04030', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Yara Luna', 'role': 'CONTACT', 'email': 'reclutamiento.proyectos@apec.com.mx', 'phone': '55 39 53 1225'}], 'facility': 'Asociacion para Evitar la Ceguera en Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Yara Luna', 'role': 'CONTACT', 'email': 'reclutamiento.proyectos@apec.com.mx', 'phone': '55 39 53 12 25'}], 'overallOfficials': [{'name': 'Valeria Sanchez Huerta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociacion para Evitar la Ceguera'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación para Evitar la Ceguera en México', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emmecell', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}