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Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
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
  Purpose
The purpose of this study was to evaluate long term efficacy and safety of topical ganciclovir treatment in Cytomegalovirus (CMV) anterior uveitis.

Condition
Anterior Uveitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Anterior chamber inflammation [ Time Frame: 4 weeks after starting treatment ] [ Designated as safety issue: No ]
    anterior chamber cell grading based on slit lamp microscopy


Secondary Outcome Measures:
  • probability of relapse-free [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]
    Kaplan-Meier curve of relapse-free probability


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
40 men, 20 women, aged 40-80 years old
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients without positive results of the CMV PCR
  • Immunocompromised patients with positive results of the CMV PCR
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486693

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: I-Jong Wang, M.D PhD National Taiwan University Hospital
  More Information

Publications:
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01486693     History of Changes
Other Study ID Numbers: 201109016RC 
Study First Received: November 16, 2011
Last Updated: December 5, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
cytomegalovirus
uveitis

Additional relevant MeSH terms:
Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Panuveitis
Iris Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016