Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT01486693
Status:
UNKNOWN
Last Update Posted:
2011-12-06
First Post:
2011-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D014605', 'term': 'Uveitis'}], 'ancestors': [{'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-12-05', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2011-12-05', 'lastUpdatePostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anterior chamber inflammation', 'timeFrame': '4 weeks after starting treatment', 'description': 'anterior chamber cell grading based on slit lamp microscopy'}], 'secondaryOutcomes': [{'measure': 'probability of relapse-free', 'timeFrame': '2 years after treatment', 'description': 'Kaplan-Meier curve of relapse-free probability'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cytomegalovirus', 'uveitis'], 'conditions': ['Anterior Uveitis']}, 'referencesModule': {'references': [{'pmid': '17669498', 'type': 'BACKGROUND', 'citation': 'Koizumi N, Suzuki T, Uno T, Chihara H, Shiraishi A, Hara Y, Inatomi T, Sotozono C, Kawasaki S, Yamasaki K, Mochida C, Ohashi Y, Kinoshita S. Cytomegalovirus as an etiologic factor in corneal endotheliitis. Ophthalmology. 2008 Feb;115(2):292-297.e3. doi: 10.1016/j.ophtha.2007.04.053. Epub 2007 Jul 31.'}, {'pmid': '20576767', 'type': 'BACKGROUND', 'citation': 'Chee SP, Jap A. Cytomegalovirus anterior uveitis: outcome of treatment. Br J Ophthalmol. 2010 Dec;94(12):1648-52. doi: 10.1136/bjo.2009.167767. Epub 2010 Jun 24.'}, {'pmid': '17296229', 'type': 'BACKGROUND', 'citation': 'van Boxtel LA, van der Lelij A, van der Meer J, Los LI. Cytomegalovirus as a cause of anterior uveitis in immunocompetent patients. Ophthalmology. 2007 Jul;114(7):1358-62. doi: 10.1016/j.ophtha.2006.09.035. Epub 2007 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate long term efficacy and safety of topical ganciclovir treatment in Cytomegalovirus (CMV) anterior uveitis.', 'detailedDescription': 'The investigators will enroll 60 patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping from January 2006 to June 2011. All the patients (40 men, 20 women) were immunocompetent and diagnosed as symptomatic CMV infection. Their medical records will be reviewed, including demographic data as well as their ophthalmic and medical histories.\n\nThe purpose of this study was to evaluate long term efficacy and safety of topical ganciclovir treatment in CMV anterior uveitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '40 men, 20 women, aged 40-80 years old', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping. All the patients were immunocompetent and diagnosed as symptomatic CMV infection.\n\nExclusion Criteria:\n\n* Patients without positive results of the CMV PCR\n* Immunocompromised patients with positive results of the CMV PCR'}, 'identificationModule': {'nctId': 'NCT01486693', 'briefTitle': 'Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis', 'orgStudyIdInfo': {'id': '201109016RC'}}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'I-Jong Wang, M.D. PhD', 'role': 'CONTACT', 'email': 'ijong@ntu.edu.tw', 'phone': '886-23123456', 'phoneExt': '65729'}, {'name': 'I-Jong Wang, M.D. PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'I-Jong Wang, M.D. PhD', 'role': 'CONTACT', 'email': 'ijong@ntu.edu.tw', 'phone': '886-23123456', 'phoneExt': '65729'}], 'overallOfficials': [{'name': 'I-Jong Wang, M.D PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}