UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000647 |
|---|---|
| Receipt number | 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 15:43:20 |
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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
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
Sponsor or person
Institute
Department of Ophtalmology of Keio University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000781
