UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	local intraarterial fibrinolysis in central retinal arteryy occlusion
Title of the study (Brief title)	LIF in CRAO
Region	Japan

Condition
Condition	central retinal artery occlusion
Classification by specialty	Neurology Ophthalmology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the proof of the efficacy of local intraarterial fibrinolysis in central retinal artery occlusion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. improvement of vision 48 hours after the treatment 2. improvement of vision 2 weeks after the treatment
Key secondary outcomes	1. improvement of angiographic visualization of optic artery after treatment 2. improvement of fundus examination after treatment 3. complication

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	local intraarterial fibrinosys using urokinase
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Aged 18 and over 2)Within 15 hours after development of symptoms 3)Visual acuity is 20/400 or loss 4)The case in which visual acuity improvement is not obtained under medical treatment (eye massage) conventionally which was performed by the time it resulted in endovascular treatment 5)The case which accepts the occlusion of clear CRA in fundus examination
Key exclusion criteria	1)improvement of visual acuity before treatment 2)the case in which the difficulty is became clear by examination before treatment for the approach to an ophthalmic artery 3)the case in which cerebral hemorrhage is diagnosed by examination before treatment 4)When a systemic bleeding disorder exists within three months 5)When consent acquisition for treatment cannot be carried out 6)The case diagnosed as angitis clinically or on examination 7)When the phenomenon remarkably being difficultty for treatment exists
Target sample size	30

Research contact person
Name of lead principal investigator	naoshi ide
Organization	St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name	Ophthalmology
Address	1197-1, yasashicho, yokohama asahi-ku, kanagawa
TEL	045-366-1111
Email	n2ide@marianna-u.ac.jp

Public contact
Name of contact person	atsushi tsuchiya
Organization	St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name	neurology
Address	1197-1, yasashicho, yokohama asahi-ku, kanagawa
TEL	045-366-1111
Homepage URL
Email	a-t1@marianna-u.ac.jp

Sponsor
Institute	St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	japan

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	聖マリアンナ医科大学横浜市西部病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 30 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 10 Month 29 Day
Anticipated trial start date	2013 Year 10 Month 29 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 29 Day
Last modified on	2016 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014215