UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024593 |
|---|---|
| Receipt number | R000028292 |
| Scientific Title | Examination of the effectiveness against retinal vascular occlusion treated with retinal endovascular surgery using tissue plasminogen activator. |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2016/10/27 16:25:07 |
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Basic information
Public title
Examination of the effectiveness against retinal vascular occlusion treated with retinal endovascular surgery using tissue plasminogen activator.
Acronym
Examination of retinal endovascular surgery against retinal vascular occlusion.
Scientific Title
Examination of the effectiveness against retinal vascular occlusion treated with retinal endovascular surgery using tissue plasminogen activator.
Scientific Title:Acronym
Examination of retinal endovascular surgery against retinal vascular occlusion.
Region
| Japan |
Condition
Condition
retinal vein occlusion
retinal artery occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the retinal endovascular therapy using tissue plasminogen activator against retinal vascular occlusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative week 1 : visual acuity, postoperative complication , Optical Coherence Tomography (OCT)
Postoperative week 4 : visual acuity, postoperative complication , OCT
Postoperative week 12 : visual acuity, postoperative complication , OCT
Postoperative week 24 : visual acuity, postoperative complication , OCT , fluorescein fundus angiography (FAG)
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
We inject tissue plasminogen activator (t-PA, a monteplase) 5000IU into a retinal vascular used in vitreous surgery.
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 undergoing vitreous surgery and stay in hospital for about one week in our hospital.
The patient receives a sufficient explanation about vitreous surgery. The patient who we can get a patient's informed consent before conducting the treatment.
Key exclusion criteria
We take patient's past medical history. We exclude a patient with cerebrovascular disorders and patient with a history of cerebral infarction and blood disease.
And the case is judged to be at high risk to use t-PA for patients.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chie Sotozono |
Organization
Kyoto Prefectual Univercity of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL
075-251-5578
csotozon@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichiro Shinkai |
Organization
Kyoto Prefectual Univercity of Medicine
Division name
Department of Ophthalmology
Zip code
Address
465 Kajii cho Hirokoji agaru Kawaramachi dori Kamigyo ku Kyoto
TEL
075-251-5578
Homepage URL
yshinkai@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectual Univercity of Medicine
Institute
Department
Personal name
Funding Source
Organization
the cost from Kyoto Prefectual Univercity of Medicine, Department of Ophthalmology
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
| 2017 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | 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 | 10 | Month | 27 | Day |
Last modified on
| 2016 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028292
