UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015726 |
|---|---|
| Receipt number | R000018294 |
| Scientific Title | Clinical evaluation for the effects of intraocular tissue plasminogen activator administration in various eye diseases |
| Date of disclosure of the study information | 2014/11/21 |
| Last modified on | 2019/05/26 12:17:32 |
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Basic information
Public title
Clinical evaluation for the effects of intraocular tissue plasminogen activator administration in various eye diseases
Acronym
Intraocular tissue plasminogen activator administration in various eye diseases
Scientific Title
Clinical evaluation for the effects of intraocular tissue plasminogen activator administration in various eye diseases
Scientific Title:Acronym
Intraocular tissue plasminogen activator administration in various eye diseases
Region
| Japan |
Condition
Condition
Various eye diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical evaluation for the effects of intraocular tissue plasminogen activator administration in various eye diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvements of visual acuity and effects of surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fibrin reaction caused by surgery and uveitis
Interventions/Control_2
subretinal hematoma
Interventions/Control_3
retinal vessel occlusive disease
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
Fibrin reaction caused by surgery and uveitis, subretinal hematoma, retinal vessel occlusive disease
Key exclusion criteria
Medical history of hemorrhagic disorder
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YASUYUKI TAKAI |
Organization
Shimane University Faculty of Medicine
Division name
Ophthalmology
Zip code
Address
Enya 89-1, Izumo, Shimane, 693-8501, Japan
TEL
0853202284
takai611@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YASUYUKI TAKAI |
Organization
Shimane University Faculty of Medicine
Division name
Ophthalmology
Zip code
Address
Enya 89-1, Izumo, Shimane, 693-8501, Japan
TEL
0853202284
Homepage URL
takai611@med.shimane-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Shimane University Faculty of Medicine, Izumo, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Shimane University Faculty of Medicine, Izumo, Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 21 | 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
| 2010 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2010 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2010 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 20 | Day |
Last modified on
| 2019 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018294
