Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis
This study is currently recruiting participants.
Verified December 2011 by National Taiwan University Hospital
Sponsor:
National Taiwan University Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01486693
First received: November 16, 2011
Last updated: December 5, 2011
Last verified: December 2011
| Tracking Information | |||||
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| First Received Date ICMJE | November 16, 2011 | ||||
| Last Updated Date | December 5, 2011 | ||||
| Start Date ICMJE | October 2011 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Anterior chamber inflammation [ Time Frame: 4 weeks after starting treatment ] [ Designated as safety issue: No ] anterior chamber cell grading based on slit lamp microscopy |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01486693 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
probability of relapse-free [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ] Kaplan-Meier curve of relapse-free probability |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis | ||||
| Official Title ICMJE | Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis | ||||
| Brief Summary | The purpose of this study was to evaluate long term efficacy and safety of topical ganciclovir treatment in Cytomegalovirus (CMV) anterior uveitis. |
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| Detailed Description | 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. The purpose of this study was to evaluate long term efficacy and safety of topical ganciclovir treatment in CMV anterior uveitis. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 40 men, 20 women, aged 40-80 years old |
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| Condition ICMJE | Anterior Uveitis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Taiwan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01486693 | ||||
| Other Study ID Numbers ICMJE | 201109016RC | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | National Taiwan University Hospital | ||||
| Study Sponsor ICMJE | National Taiwan University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Taiwan University Hospital | ||||
| Verification Date | December 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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