UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the efficacy and safety of intra-retinal arterial fibrinolysis for central retinal artery occlusion
Title of the study (Brief title)	Intra-retinal arterial fibrinolysis
Region	Japan

Condition
Condition	Central Retinal Artery Occlusion(CRAO)
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To dislodge the clot in eyes with CRAO by tissue plasminogen activator to get improved vision
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity 24 weeks after surgery
Key secondary outcomes	1) Improvement of visual acuity from baseline to 24 weeks after surgery 2) Change of retinal thickness from baseline to 24 weeks after surgery 3) Laser speckle from baseline to 24 weeks after surgery 4) Occurrence rate of surgical complications 5) Vison loss

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	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	To inject tPA which concentration is prepared 8000unit/0.1ml
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)More than 20-year-old 2)Patients with CRAO 3)Patients who are able to stay in the hospital 4)Patients without cardiovascular diseases 5)Patients who obtained the informed consent
Key exclusion criteria	1)Patients who may have side effects by tPA 2)Pregnancy 3)Patients judged to be appropriate
Target sample size	10

Research contact person
Name of lead principal investigator	Kazuaki Kadonosono
Organization	Yokohama City University Medical Center
Division name	Department of Ophthalmology
Address	4-57 Urafune-cho, Minami-ku, Yokohama, Japan
TEL	045-261-5656
Email	kado@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Hiroshi Inazaki
Organization	Yokohama City University Medical Center
Division name	Department of Ophthalmology
Address	4-57 Urafune-cho, Minami-ku, Yokohama, Japan
TEL	045-261-5656
Homepage URL
Email	ojionobao@yahoo.co.jp

Sponsor
Institute	Yokohama City University
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	Yokohama City University
Organization
Division
Category of Funding Organization	Other
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	横浜市立大学附属市民総合医療センター（神奈川県）/Yokohama City University Medical Center

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 14 Day
Anticipated trial start date	2015 Year 09 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 07 Month 01 Day
Last modified on	2016 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026476