Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2026-01-01 @ 7:01 PM
Study NCT ID:
NCT04947592
Status:
UNKNOWN
Last Update Posted:
2021-12-15
First Post:
2021-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SD-OCT Guided Treatment of Fungal Chorioretinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002825', 'term': 'Chorioretinitis'}], 'ancestors': [{'id': 'D012173', 'term': 'Retinitis'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D002833', 'term': 'Choroiditis'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D015866', 'term': 'Uveitis, Posterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-06-24', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best corrected visual acuity (BCVA)', 'timeFrame': '6 months', 'description': 'Change in BCVA in LOG MARS(logarithm minimum angle of resolution'}], 'secondaryOutcomes': [{'measure': 'optical coherence tomography (OCT) foveal thickness', 'timeFrame': '6 months', 'description': 'change in foveal thickness measured in micrometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fungal', 'chorioretinitis', 'OCT'], 'conditions': ['Fungal Retinitis']}, 'descriptionModule': {'briefSummary': 'Fungal Chorioretinitis is a vision threatening condition.The investigators evaluate the efficacy of SD-OCT role in the treatment', 'detailedDescription': 'Baseline ,and postoperative 1 ,6 and 12 months full ophthalmic examination and SD-OCT was done.Procedure included oral fluconazole treatment 1 tablet once for 14 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'at least 18 years old patient with fungal chorioretinitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- fungal chorioretinitis\n\nExclusion Criteria:\n\n* vitritis\n* other macular lesion\n* macular scar'}, 'identificationModule': {'nctId': 'NCT04947592', 'briefTitle': 'SD-OCT Guided Treatment of Fungal Chorioretinitis', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Outcome of SD-OCT Guided Oral Anti-fungal Treatment of Fungal Chorioretinitis', 'orgStudyIdInfo': {'id': 'Hamaky13'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fluconazole 150 mg', 'type': 'DRUG', 'description': 'fluconazole 150 MG once daily for 14 days'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46266', 'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'TAREK R ELHAMAKY, MD', 'role': 'CONTACT'}], 'facility': 'INMC', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'TAREK R ELHAMAKY, MD', 'role': 'CONTACT', 'email': 'thamaky@ibnnafees.com', 'phone': '0503207889'}, {'name': 'TAREK ELHAMAKY', 'role': 'CONTACT', 'email': 'thamaky@ibnnafees.com', 'phone': '0503207889'}], 'overallOfficials': [{'name': 'TAREK ELHAMAKY', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tarek Roshdy mohamed Mahgoub ELhamaky', 'investigatorAffiliation': 'Benha University'}}}}