Cytomegalovirus EndotheliitisNCT01359995
Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
An observational study of Cytomegalovirus Endotheliitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Cytomegalovirus Endotheliitis
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 4 men, 3 women, aged 40-90 years old
Who may be able to join
- immunocompetent patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping receiving penetrating keratoplasty
Who cannot join
- patients receiving systemic or intravitreal ganciclovir before topical ganciclovir use
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
I-Jong Wang, M.D. PhD, 886-23123456 ext. 65729, ijong@ms8.hinet.net
I-Jong Wang, M.D. PhD
About this study
The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.
Read the detailed description
In this study, we recruit 7 immunocompetent patients with unexplained graft failures, which mimicked herpetic anterior uveitis and graft rejection initially, were diagnosed as CMV endotheliitis after aqueous tapping for CMV polymerase chain reaction (PCR). Topical ganciclovir was used to control and prevent the reactivation of CMV without systemic application and their clinical courses were presented after this treatment modality.
The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.
- Conditions
- Cytomegalovirus Endotheliitis
- Keywords
- cytomegalovirus endotheliitis
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical courses before and after topical ganciclovir in patients with CMV endotheliitis
evaluations including aqueous PCR for CMV, endothelium cell density on confocal microscopy,degree of anterior chamber inflammation..
Measured: participants will be monitored after receiving topical ganciclovir,an expected average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus EndotheliitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- I-Jong Wang, M.D. PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359995
- Sponsor's protocol ID
- 201010033R
- Status last verified
- May 2011
- First submitted
- 16 May 2011
- Last updated
- 25 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17669498Chee SP, Bacsal K, Jap A, Se-Thoe SY, Cheng CL, Tan BH. Clinical features of cytomegalovirus anterior uveitis in immunocompetent patients. Am J Ophthalmol. 2008 May;145(5):834-40. doi: 10.1016/j.ajo.2007.12.015. Epub 2008 Feb 6.
PubMed 18255045Anshu A, Chee SP, Mehta JS, Tan DT. Cytomegalovirus endotheliitis in Descemet's stripping endothelial keratoplasty. Ophthalmology. 2009 Apr;116(4):624-30. doi: 10.1016/j.ophtha.2008.10.031. Epub 2009 Feb 4.
PubMed 19195708
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
- ClinicalTrials.gov ID
- NCT01359995
- Acronym / sponsor ID
- 201010033R
- Conditions
- Cytomegalovirus Endotheliitis
- Keywords
- cytomegalovirus endotheliitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 25 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.
Detailed description
In this study, we recruit 7 immunocompetent patients with unexplained graft failures, which mimicked herpetic anterior uveitis and graft rejection initially, were diagnosed as CMV endotheliitis after aqueous tapping for CMV polymerase chain reaction (PCR). Topical ganciclovir was used to control and prevent the reactivation of CMV without systemic application and their clinical courses were presented after this treatment modality.
The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 4 men, 3 women, aged 40-90 years old
Key inclusion criteria (1 listed)
- immunocompetent patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping receiving penetrating keratoplasty
Key exclusion criteria (1 listed)
- patients receiving systemic or intravitreal ganciclovir before topical ganciclovir use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical courses before and after topical ganciclovir in patients with CMV endotheliitis
Time frame: participants will be monitored after receiving topical ganciclovir,an expected average of 1 year
evaluations including aqueous PCR for CMV, endothelium cell density on confocal microscopy,degree of anterior chamber inflammation..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2011.
- Background: PubMed 17669498Koizumi 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.
- Background: PubMed 18255045Chee SP, Bacsal K, Jap A, Se-Thoe SY, Cheng CL, Tan BH. Clinical features of cytomegalovirus anterior uveitis in immunocompetent patients. Am J Ophthalmol. 2008 May;145(5):834-40. doi: 10.1016/j.ajo.2007.12.015. Epub 2008 Feb 6.
- Background: PubMed 19195708Anshu A, Chee SP, Mehta JS, Tan DT. Cytomegalovirus endotheliitis in Descemet's stripping endothelial keratoplasty. Ophthalmology. 2009 Apr;116(4):624-30. doi: 10.1016/j.ophtha.2008.10.031. Epub 2009 Feb 4.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
I-Jong Wang, M.D. PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Endotheliitis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact I-Jong Wang, M.D. PhD (886-23123456 ext. 65729, ijong@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical courses before and after topical ganciclovir in patients with CMV endotheliitis (time frame: participants will be monitored after receiving topical ganciclovir,an expected average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01359995, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2011.