NCT01486693

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

November 16, 2011

Last Update Submit

December 5, 2011

Conditions

Anterior Uveitis

Keywords

cytomegalovirusuveitis

Outcome Measures

Primary Outcomes (1)

  • Anterior chamber inflammation

    anterior chamber cell grading based on slit lamp microscopy

    4 weeks after starting treatment

Secondary Outcomes (1)

  • probability of relapse-free

    2 years after treatment

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 men, 20 women, aged 40-80 years old

You may qualify if:

  • 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.

You may not qualify if:

  • Patients without positive results of the CMV PCR
  • Immunocompromised patients with positive results of the CMV PCR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Related Publications (3)

  • 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: 17669498BACKGROUND

  • 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: 20576767BACKGROUND

  • 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.

    PMID: 17296229BACKGROUND

MeSH Terms

Conditions

Uveitis, AnteriorUveitis

Condition Hierarchy (Ancestors)

PanuveitisUveal DiseasesEye Diseases

Study Officials

  • I-Jong Wang, M.D PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

I-Jong Wang, M.D. PhD

CONTACT

886-23123456ijong@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2011

First Posted

December 6, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2011

Study Completion

September 1, 2012

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations

TW(1)