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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000000647
Receipt No. R000000781
Scientific Title To evaluate safety and efficacy of intravitreal Bevaxizumab injection for intraocular neovasculalization
Date of disclosure of the study information 2007/03/22
Last modified on 2007/03/20

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Basic information
Public title To evaluate safety and efficacy of intravitreal Bevaxizumab injection for intraocular neovasculalization
Acronym Intravitreal Bevaxizumab injection for intraocular neovasculalization
Scientific Title To evaluate safety and efficacy of intravitreal Bevaxizumab injection for intraocular neovasculalization
Scientific Title:Acronym Intravitreal Bevaxizumab injection for intraocular neovasculalization
Region
Japan

Condition
Condition ARMD,BRVO,CRVO,DR,CNV
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes To acess side-effect and examin visual acuity,thickness of retina and retinal angiography
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 Intravitreal injection
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 Outpatient of Keio University with ARMD,BRVO,CRVO,DR,CNV that are able to examined by angiography or checked retinal thickness.
Key exclusion criteria Cr>3.0mg/dL
anstable angina
malignant arrhythmia
HT:140/80mmHg>
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Inoue
Organization Keio University Hospital
Division name Ophtalmology
Zip code
Address Sinanomachi35,Sinjukuku
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Department of Ophthalmology
Division name Department of Ophthalmology
Zip code
Address Sinanomachi 35,Sinjukuku
TEL 03-3353-1211
Homepage URL
Email

Sponsor
Institute Department of Ophtalmology of Keio University Hospital
Institute
Department

Funding Source
Organization Department of Ophtalmology of Keio University Hospital
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

Other administrative information
Date of disclosure of the study information
2007 Year 03 Month 22 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
Date of protocol fixation
2007 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2007 Year 04 Month 01 Day
Last follow-up date
2007 Year 10 Month 01 Day
Date of closure to data entry
2008 Year 01 Month 01 Day
Date trial data considered complete
2008 Year 03 Month 01 Day
Date analysis concluded
2008 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 03 Month 20 Day
Last modified on
2007 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000781

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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