Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis

Anterior Uveitis Clinical Trial

Official title:

Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01486693
• Other study ID #: 201109016RC
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2011
• Last updated: December 5, 2011
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2011
• Source: National Taiwan University Hospital
• Contact: I-Jong Wang, M.D. PhD
• Phone: 886-23123456
• Email: ijong[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to evaluate long term efficacy and safety of topical ganciclovir treatment in Cytomegalovirus (CMV) anterior uveitis.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anterior Uveitis
• Iridocyclitis
• Iritis
• Uveitis
• Uveitis, Anterior

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View 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. Epub 2007 Jul 31. — View 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. Epub 2007 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior chamber inflammation	anterior chamber cell grading based on slit lamp microscopy	4 weeks after starting treatment	No
Secondary	probability of relapse-free	Kaplan-Meier curve of relapse-free probability	2 years after treatment	No