Clinical Outcomes of Topical Ganciclovir Treatment in Cyt... | NCT01486693

Studies
Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis

NCT01486693

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 6, 2011Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Anterior Uveitis

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Nov 16, 2011

First Submission Date that Met QC Criteria

Dec 5, 2011

First Posted Date

Dec 6, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 5, 2011

Last Update Posted Date

Dec 6, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anterior chamber inflammation	anterior chamber cell grading based on slit lamp microscopy	4 weeks after starting treatment

Secondary Outcomes

Measure	Description	Time Frame
probability of relapse-free	Kaplan-Meier curve of relapse-free probability	2 years after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
I-Jong Wang, M.D. PhD	Contact	886-23123456	65729	ijong@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
I-Jong Wang, M.D PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei			Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17669498	Background	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.
20576767	Background

ID	Term
D014606	Uveitis, Anterior
D014605	Uveitis

ID	Term
D015864	Panuveitis
D014603	Uveal Diseases
D005128	Eye Diseases