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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013595
Receipt No. R000015884
Scientific Title Analysis of the effect of intravitreal methotrexate for refractory intraocular inflammation
Date of disclosure of the study information 2014/06/01
Last modified on 2019/04/05

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000015884

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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