UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029838 |
|---|---|
| Receipt number | R000034085 |
| Scientific Title | Treatment of plasminogen activator in ophthalmology |
| Date of disclosure of the study information | 2017/11/06 |
| Last modified on | 2018/11/29 17:57:55 |
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Basic information
Public title
Treatment of plasminogen activator in ophthalmology
Acronym
Treatment of t-PA in ophthalmology
Scientific Title
Treatment of plasminogen activator in ophthalmology
Scientific Title:Acronym
Treatment of t-PA in ophthalmology
Region
| Japan |
Condition
Condition
Submacular hemorrhage, Retinal vein occlusion, Fibrin formation due to postoperative inflammation
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of the treatment protocol using a tissue plasminogen activator in ophthalmology.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event
Key secondary outcomes
Visual acuity, Visual field, Retinal thickness, Intraocular pressure
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
Injecting tissue plasminogen activator(0.025mg/0.1ml)0.02-0.2ml into a subretinal cavity or a retinal vascular in vitreous surgery.
Injecting tissue plasminogen activator(0.025mg/0.1ml)0.05-0.1ml into an anterior chamber or a intravitreal cavity with fibrin formation.
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)Patients who have submacular hemorrhage, RVO, fibrin formation due to postoperative inflammation
(2)Patients who were sufficient explanatation about using t-PA, and could get informed consent.
Key exclusion criteria
(1)Patients who are during lactation or pregnancy or expected pregnancy
(2)Patients who have active eye/eyelid inflammation or disease or infection
(3)Patients who have hemorrhagic diathesis
(4)Patients who are judged to be inappropriate for this trial by the judgement of the doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Sugiyama |
Organization
Kanazawa University
Division name
Department of Ophthalmology
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa
TEL
0762652403
ksugi@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Masaki |
Organization
Kanazawa University
Division name
Department of Ophthalmology
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa
TEL
0762652403
Homepage URL
tmasaki@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Kanazawa University
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
| 2017 | Year | 11 | Month | 06 | 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
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 06 | 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
| 2017 | Year | 11 | Month | 06 | Day |
Last modified on
| 2018 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034085
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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