Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-04 @ 2:45 AM
Study NCT ID:
NCT00372294
Status:
UNKNOWN
Last Update Posted:
2008-07-30
First Post:
2006-09-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002825', 'term': 'Chorioretinitis'}, {'id': 'D014123', 'term': 'Toxoplasmosis'}], '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'}, {'id': 'D003048', 'term': 'Coccidiosis'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-07-28', 'studyFirstSubmitDate': '2006-09-05', 'studyFirstSubmitQcDate': '2006-09-05', 'lastUpdatePostDateStruct': {'date': '2008-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Toxoplasmosis', 'Chorioretinitis', 'Intravitreal Clindamycin', 'Dexamethasone in chorioretinitis', 'Toxoplasmic'], 'conditions': ['Chorioretinitis']}, 'descriptionModule': {'briefSummary': 'Toxoplasmosis, an intra cellular parasite, is a very important cause of chorioretinitis. The goal of treatment is arresting multiplication of the parasite in its inflammatory active phase. In this study the investigators try to compare the efficacy of the classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon) with intravitreal Clindamycin \\& Dexamethasone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Toxoplasmic chorioretinitis\n* Location of the lesion within zone I of the retina or a lesion greater than 2DD with 3+-4+ vitreous inflammation in zone II or III\n* No allergic history to the used drugs\n* No any other diseases\n\nExclusion Criteria:\n\n* Any allergic reaction to the used medications\n* One eyed patients\n* Partially treated patients'}, 'identificationModule': {'nctId': 'NCT00372294', 'briefTitle': 'To Compare Intravitreal Clindamycin & Dexamethasone With Classic Treatment of Toxoplasmic Retinochoroiditis', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '8415'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Classic regimen (Pyrimethamine-Sulfadiazine + Prednisolon)', 'interventionNames': ['Drug: pyrimethamine-sulfadiazine + prednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Intravitreal Clindamycin \\& Dexamethasone', 'interventionNames': ['Drug: Clindamycin+Dexamethasone']}], 'interventions': [{'name': 'pyrimethamine-sulfadiazine + prednisolone', 'type': 'DRUG', 'description': 'Administration of pyrimethamine-sulfadiazine + prednisolone', 'armGroupLabels': ['1']}, {'name': 'Clindamycin+Dexamethasone', 'type': 'DRUG', 'description': 'Intravitreal injection of Clindamycin+Dexamethasone', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16666', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Ophthalmic Research Center', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Masoud Soheilian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Research Center of Shaheed Beheshti Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}