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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029657
Receipt No. 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 2017/10/22

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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
Middle name
Last name Hiroshi Takase
Organization Tokyo Medical and Dental University
Division name Department of Ophthalmology & Visual Science
Zip code
Address 1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL +81-3-5803-5302
Email h.takase.oph@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Takase
Organization Tokyo Medical and Dental University
Division name Department of Ophthalmology & Visual Science
Zip code
Address 1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL +81-3-5803-5302
Homepage URL
Email h.takase.oph@tmd.ac.jp

Sponsor
Institute Department of Ophthalmology & Visual Science, Tokyo Medical and Dental University
Institute
Department

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
Address
Tel
Email

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
2017 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033888

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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