UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013595 |
|---|---|
| Receipt number | 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 09:10:38 |
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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
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
egawa.m@tokushima-u.ac.jp
Sponsor or person
Institute
Institute of Health Biosiences, The University of Tokushima Graduate School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015884
