UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029657 |
|---|---|
| Receipt number | R000033888 |
| Scientific Title | A study of intravitreal injection of ganciclovir for herpetic intraocular infectious diseases |
| Date of disclosure of the study information | 2017/10/23 |
| Last modified on | 2020/04/24 16:09:57 |
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Basic information
Public title
A study of intravitreal injection of ganciclovir for herpetic intraocular infectious diseases
Acronym
A study of intravitreal injection of ganciclovir for herpetic intraocular infectious diseases
Scientific Title
A study of intravitreal injection of ganciclovir for herpetic intraocular infectious diseases
Scientific Title:Acronym
A study of intravitreal injection of ganciclovir for herpetic intraocular infectious diseases
Region
| Japan |
Condition
Condition
Intraocular infectious diseases due to human herpes viruses
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at investigating the efficacy and safety of intravitreal injection of ganciclovir to intraocular infectious diseases due to human herpes viruses.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission of the intraocular inflammation, visual acuity, and recurrence rate in two years.
Key secondary outcomes
Rate of adverse events, and relapse rate (central nerve system and other lesion)
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
Perform intravitreal ganciclovir (1000 ug/100 ul) injection.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The eyes in which herpes simplex viruses, varicella-zoster virus, or cytomegalovirus was detected by PCR using intraocular fluids, or for the eyes in which human herpes virus infection is strongly suspected and there is a high possibility that the eye will go blind due to retinal necrosis or secondary glaucoma.
Key exclusion criteria
History of serious adverse reactions by methotrexate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takase |
Organization
Tokyo Medical and Dental University
Division name
Department of Ophthalmology & Visual Science
Zip code
113-8519
Address
1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
+81-3-5803-5302
h.takase.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takase |
Organization
Tokyo Medical and Dental University
Division name
Department of Ophthalmology & Visual Science
Zip code
113-8519
Address
1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
+81-3-5803-5302
Homepage URL
h.takase.oph@tmd.ac.jp
Sponsor or person
Institute
Department of Ophthalmology & Visual Science, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology & Visual Science, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University Hospital, Clinical Research Center
Address
1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
Tel
03-5803-4575
mkan-rinsho.adm@tmd.ac.jp
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
| 2017 | Year | 10 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 22 | Day |
Last modified on
| 2020 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033888
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
