UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018977 |
|---|---|
| Receipt number | R000021954 |
| Scientific Title | Topical 0.5% ganciclovir therapy for cytomegalovirus corneal endothelitis and iritis |
| Date of disclosure of the study information | 2015/09/10 |
| Last modified on | 2019/03/17 23:56:31 |
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Basic information
Public title
Topical 0.5% ganciclovir therapy for cytomegalovirus corneal endothelitis and iritis
Acronym
0.5%ganciclovir therapy
Scientific Title
Topical 0.5% ganciclovir therapy for cytomegalovirus corneal endothelitis and iritis
Scientific Title:Acronym
0.5%ganciclovir therapy
Region
| Japan |
Condition
Condition
cytomegalovirus corneal endotheliitis and iritis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will use the topical 0.5%ganciclovir for cytomegalovirus corneal endtheliitis and iritis and study the effect of that therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of improvement of inflammation
(disappear of inflammation and more than 500 endothelial cell)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
eye drop
8times for severe case
6times for modarete case
4times for mild case
1drop per 1time
taper after improvement
stop when PCR shows negative of CMV
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
diagnosed as cytomegalovirus corneal endotheliitis and iritis
over16
Key exclusion criteria
inappropriate person
allergy for ganciclovir
pregnant woman
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsue Imamachi |
Organization
Shimane university hospital
Division name
Ophthalmology
Zip code
Address
enya izumo city Shimane
TEL
0853-20-2284
kimama@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsue Imamachi |
Organization
Shimane university hospital
Division name
Ophthalmol
Zip code
Address
enya izumo city Shimane
TEL
0853-20-2284
Homepage URL
kimama@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane university hospital
Institute
Department
Personal name
Funding Source
Organization
Shimane university hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 10 | Day |
Last modified on
| 2019 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021954
