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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022972
Receipt No. R000026476
Scientific Title Study of the efficacy and safety of intra-retinal arterial fibrinolysis for central retinal artery occlusion
Date of disclosure of the study information 2016/07/01
Last modified on 2016/07/01

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Basic information
Public title Study of the efficacy and safety of intra-retinal arterial fibrinolysis for central retinal artery occlusion
Acronym Intra-retinal arterial fibrinolysis
Scientific Title Study of the efficacy and safety of intra-retinal arterial fibrinolysis for central retinal artery occlusion
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Kazuaki Kadonosono
Organization Yokohama City University Medical Center
Division name Department of Ophthalmology
Zip code
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
1st name
Middle name
Last name Hiroshi Inazaki
Organization Yokohama City University Medical Center
Division name Department of Ophthalmology
Zip code
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

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)

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 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

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 Open public recruiting
Date of protocol fixation
2015 Year 07 Month 14 Day
Date of IRB
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

Other
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

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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