UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of oral administration of tranexamic acid for refractory macular edema
Title of the study (Brief title)	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
Name of lead principal investigator	Takeyama Masayuki
Organization	Aichi medical university hospital
Division name	Department of Ophthalmology
Address	1-1, Yazakokarimata, Nagakute, Aichi
TEL	0561-62-3311
Email	mtakeyam@aichi-med-u.ac.jp

Public contact
Name of contact person	Takeyama Masayuki
Organization	Aichi medical university
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016990