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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:
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
History of Changes
  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:

U.S. FDA Resources

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

Contacts
Contact: I-Jong Wang, M.D. PhD 886-23123456 ext 65729 ijong@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: I-Jong Wang, M.D. PhD     886-23123456 ext 65729     ijong@ntu.edu.tw    
Principal Investigator: I-Jong Wang, M.D. PhD            
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
Chorioretinitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
 Choroid Diseases
Uveitis, Posterior
Panuveitis
Iris Diseases
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013