UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022972 |
|---|---|
| Receipt number | 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 17:56:04 |
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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
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
ojionobao@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026476
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
