UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006430 |
|---|---|
| Receipt number | R000007632 |
| Scientific Title | Treatment of fibrin formation with intraocular tissue plasminogen activator |
| Date of disclosure of the study information | 2011/09/28 |
| Last modified on | 2011/09/28 22:48:59 |
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Basic information
Public title
Treatment of fibrin formation with intraocular tissue plasminogen activator
Acronym
Treatment of fibrin formation with intraocular t-PA
Scientific Title
Treatment of fibrin formation with intraocular tissue plasminogen activator
Scientific Title:Acronym
Treatment of fibrin formation with intraocular t-PA
Region
| Japan |
Condition
Condition
Patients with intraocular fibrin formation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of
intravitreal tissue plasminogen activator (tPA) in patients with intraocular fibrin formation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
The evaluation of intraocular fibrin formation at the next day of intraocular injection of tPA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To the case in which intraocular fibrin is formed with the postoperative case or the pathological change in a retinal hemorrhage, steroid medicine and a nonsteroidal anti-inflammatory drug are first prescribed for the patient, and the existence of the dissolution of fibrin is observed.
It is considered as the objects of this examination of the case as which the dissolution of fibrin is not regarded under the medical treatment.
After explaining along with a protocol and obtaining consent, 25 microgram/0.1 ml of tPA are injected into the eye under clean operation.
It is evaluated of fibrin formation on the next day, one week, one month, and three months after the injection.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
It is considered as the objects of this examination of the case as which the dissolution of fibrin is not regarded under the medical treatment.
Key exclusion criteria
The case which has allergy in tPA
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Inoue Masayuki |
Organization
Tokushima university hospital
Division name
Ophthalmology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima-shi, Tokushima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima university hospital
Division name
Ophthalmology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima-shi, Tokushima, Japan
TEL
Homepage URL
Sponsor or person
Institute
Tokushima university hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima university hospital Ophthalmology
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 09 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2011 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | 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
| 2011 | Year | 09 | Month | 28 | Day |
Last modified on
| 2011 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007632
