UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028467 |
|---|---|
| Receipt number | R000032550 |
| Scientific Title | Clinical research about intraocular injection of tissue plasminogen activator(cleactor) |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2022/02/05 14:16:44 |
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Basic information
Public title
Clinical research about intraocular injection of tissue plasminogen activator(cleactor)
Acronym
Clinical research about intraocular injection of tissue plasminogen activator(cleactor)
Scientific Title
Clinical research about intraocular injection of tissue plasminogen activator(cleactor)
Scientific Title:Acronym
Clinical research about intraocular injection of tissue plasminogen activator(cleactor)
Region
| Japan |
Condition
Condition
diabetes retinopathy,retina vein occlusion,macular degeneration,subretinal hemorrhage,macula edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of safety and efficacy about intraocular injection of tissue plasminogen activator(t-PA)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity
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
Object : The patient of diabetes retinopathy,retina vein occlusion,macular degeneration,subretinal hemorrhage,macula edema.
Interventions : Intraocular injection of t-PA alone or other necessary treatment in parallel.
Term : About 2weeks hospitalization.
Dose : 40,000 IU(0.1ml) .
Approach : Using a 27G needle intravitreal injection from 3.5mm rear from a limbus cornea.
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
The patient who was enough explained and understand this study.
The patient who agree this study by the free will and sign consent forms.
The patient who was diagnosed t-PA is appropriate.
Key exclusion criteria
The patient who judged t-PA is inappropriate by principal investigator or member of a research project.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Horiguchi |
Organization
Fujita Health University Hospital
Division name
Ophthalmology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL
81-0562-95-5177
masayuki@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Mizuguchi |
Organization
Fujita Health University Hospital
Division name
Ophthalmology
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho, Toyoake-city, Aichi
TEL
81-0562-95-5177
Homepage URL
mizu@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
None
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 | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 31 | Day |
Last modified on
| 2022 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032550
