UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of the effect of intravitreal methotrexate for refractory intraocular inflammation
Acronym	Analysis of the effect of intravitreal methotrexate for refractory intraocular inflammation
Scientific Title	Analysis of the effect of intravitreal methotrexate for refractory intraocular inflammation
Scientific Title:Acronym	Analysis of the effect of intravitreal methotrexate for refractory intraocular inflammation
Region	Japan

Condition
Condition	Refractory intraocular inflammation
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To analyze efficacy and safety of intravitreal methotrexate for refractory intraocular inflammation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate improvement of intraocular inflammation after treatment for 6 months
Key secondary outcomes	Adverse event

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	Follow up duration:6 month Intravitreal injection of methotrexate 400ug/100ul is administered once and repeated for recurrence case(interval more than one month)
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	1)patient of refractory intraocular inflammation 2)written informed consent 3)patient who was judged by doctor to be able to receive the protocol therapy
Key exclusion criteria	1)history of serious adverse reaction by methotrexate 2)active infectious disease of eye 3)patient who was judged by doctor not to be able to receive drug
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Mariko Egawa
Organization	Institute of Health Biosiences, The University of Tokushima Graduate School
Division name	Ophthalmology
Zip code
Address	3-18-15 Kuramoto, Tokushima, 770-8503, Japan
TEL	088-633-7163
Email	egawa.m@tokushima-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Mariko Egawa
Organization	Institute of Health Biosiences, The University of Tokushima Graduate School
Division name	Ophthalmology
Zip code
Address	3-18-15 Kuramoto, Tokushima, 770-8503, Japan
TEL	088-633-7163
Homepage URL
Email	egawa.m@tokushima-u.ac.jp

Sponsor
Institute	Institute of Health Biosiences, The University of Tokushima Graduate School
Institute
Department

Funding Source
Organization	None
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	徳島大学病院（徳島県）　Tokushima University Hospital（Tokushima)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 01 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	2014 Year 05 Month 31 Day
Date of IRB	2014 Year 05 Month 26 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 04 Month 01 Day
Last modified on	2019 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015884