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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014601
Receipt No. R000016990
Scientific Title Effect of oral administration of tranexamic acid for refractory macular edema
Date of disclosure of the study information 2014/07/25
Last modified on 2016/09/26

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Basic information
Public title Effect of oral administration of tranexamic acid for refractory macular edema
Acronym Oral administration of tranexamic acid for refractory macular edema
Scientific Title Effect of oral administration of tranexamic acid for refractory macular edema
Scientific Title:Acronym Oral administration of tranexamic acid for refractory macular edema
Region
Japan

Condition
Condition macular edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of oral administration of tranexamic acid for refractory macular edema
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual acuity, retinal thickness
Key secondary outcomes

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 Tranexamic acid 1500mg oral administration for 14 days
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Refractory macular edema
20 years and older
written informed consent
Key exclusion criteria Artificial dialysis
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takeyama Masayuki
Organization Aichi medical university hospital
Division name Department of Ophthalmology
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email mtakeyam@aichi-med-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takeyama Masayuki
Organization Aichi medical university
Division name Department of Ophthalmology
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Homepage URL
Email mtakeyam@aichi-med-u.ac.jp

Sponsor
Institute Aichi medical university hospital
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 愛知医科大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 25 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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 25 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
2016 Year 05 Month 31 Day
Date trial data considered complete
2016 Year 05 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 21 Day
Last modified on
2016 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016990

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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