UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013174 |
|---|---|
| Receipt number | R000015362 |
| Scientific Title | The effect of kallidinogenase for the retina thickness and visual acuity etc.after intravitreal bevacizumab for diabetic macula edema. |
| Date of disclosure of the study information | 2014/02/17 |
| Last modified on | 2015/02/19 17:10:07 |
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Basic information
Public title
The effect of kallidinogenase for the retina thickness and visual acuity etc.after intravitreal bevacizumab for diabetic macula edema.
Acronym
The effect of kallidinogenase for diabetic macula edema after intravitreal bevacizumab.
Scientific Title
The effect of kallidinogenase for the retina thickness and visual acuity etc.after intravitreal bevacizumab for diabetic macula edema.
Scientific Title:Acronym
The effect of kallidinogenase for diabetic macula edema after intravitreal bevacizumab.
Region
| Japan |
Condition
Condition
diabetic macula edema
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of kallidinogenase for diabetic macula edema
after intravitreal bevacizumab (IVB)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Foveal retinal thickness,visual acuity
Key secondary outcomes
Recurrence of the edema,number of the exaples of aan ophthalmic treatment addition,number of the times of an addition,and period to an addition,the safety assessment(rate of adverse events)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Kallidinogenase(+)oral
Interventions/Control_2
Kallidinogenase(-)
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
Patients underwent intravitreal bevacizumab for diabetic macula edema,who met the all inclusion criteria.
(a)Older than 20tears of age at the time of the acquisition agreement.
(b)Allowed to go to the Tsukazaki Hospital regularly for one year.
(c)Obtained consentin written foem of the study participants.
Key exclusion criteria
(a)Sever side effects by the past kallidinogenase preparations.
(b)Treated by kallidinogenase within one month of preparation before the start of this drug.
(c)HbA1c 10%.
(d)Treated with steroids drugs or laser photocoagulation for diabetic macula edema within four months
(e)Pregnant and lactating woman or woman who may become pregnant.
(f)Any others judged by the doctor in charge to be ineligible for subjects in the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zaigen Ohara |
Organization
Tsukazaki hospital
Division name
Ophthalmology
Zip code
Address
68-1 Aboshikuwaku Himeji Hyogo Japa
TEL
0
z.ohhara@tsukazaki-eye.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zaigen Ohara |
Organization
Tsukazaki hospital
Division name
Ophthalmology
Zip code
Address
68-1 Aboshikuwaku Himeji Hyogo Japan
TEL
079-272-8555
Homepage URL
z.ohhara@tsukazaki-eye.net
Sponsor or person
Institute
Tsukazaki hospital
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
ツカザキ病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 17 | 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
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 17 | 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
| 2014 | Year | 02 | Month | 16 | Day |
Last modified on
| 2015 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015362
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| Registered date | File name |
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| Registered date | File name |
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