UMIN-CTR Clinical Trial

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
Email	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
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	Tokyo Medical and Dental University Hospital, Clinical Research Center
Address	1-5-45 Yusima, Bunkyo-ku, Tokyo 113-8519, Japan
Tel	03-5803-4575
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033888