Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-22 @ 5:24 PM
Study NCT ID:
NCT02151318
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The ophthalmologist will collect samples from the tissue that is removed during patients eye surgery that would otherwise be discarded or thrown away. Researchers will collect the sample and grow in the laboratory conditions. These cells will then be studied for further research on glaucoma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of new glaucoma medications to reduce TM cellular pathologies associated with the disease glaucoma.', 'timeFrame': '6 weeks', 'description': 'TM cell biopsy samples from patients with glaucoma will be harvested and cultured in a laboratory setting to grow primary human TM cells. These cells will be used to test different medications, looking at the medications ability to reduce cellular pathologies commonly seen in TM tissue of patients with glaucoma. Pathologies include myocilin aggregation, and cell death. This will help researchers to determine the most effective compounds in treating glaucoma.'}], 'secondaryOutcomes': [{'measure': 'Cultured TM cell toxicity caused by new glaucoma medications', 'timeFrame': '6 weeks', 'description': 'Cultured primary TM cells treated with various new medications synthesized to treat cellular pathologies associated with glaucoma, will also be analyzed to look at toxicity caused by the treatments themselves. THis will help to determine the safety of these new medications prior to being administered to patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will collect tissue from patients undergoing trabeculectomy for primary open-angle glaucoma treatment. This tissue would normally be discarded. These trabecular meshwork (TM) cells can be cultured and used experimentally to better understand the mechanisms of glaucoma. These TM biopsies will be cultured on the same day as the trabeculectomy using established techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having glaucoma and undergoing a trabeculotomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having glaucoma and undergoing a trabeculotomy\n* Sign ICF (Informed Consent Form)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02151318', 'briefTitle': 'Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Culturing TM Cells From Primary Open-angle Glaucoma Patient Biopsies', 'orgStudyIdInfo': {'id': '15309'}}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hosipital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': "Byrd Alzheimer's Institute", 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Chad A Dickey, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of South Florida department of Molecular Medicine and Byrd Alzheimer's Institute"}, {'name': 'Carla Bourne, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of South Florida and Tampa General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}