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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013174
Receipt No. 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

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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
Email 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
Email z.ohhara@tsukazaki-eye.net

Sponsor
Institute Tsukazaki hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015362

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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