UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012248 |
|---|---|
| Receipt number | R000014320 |
| Scientific Title | Study for efficacy and safety of intravitreal injection of bevacizumab (Avastin) |
| Date of disclosure of the study information | 2013/11/08 |
| Last modified on | 2016/06/20 16:11:40 |
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Basic information
Public title
Study for efficacy and safety of intravitreal
injection of bevacizumab (Avastin)
Acronym
Study for efficacy and safety of intravitreal
injection of bevacizumab (Avastin)
Scientific Title
Study for efficacy and safety of intravitreal
injection of bevacizumab (Avastin)
Scientific Title:Acronym
Study for efficacy and safety of intravitreal
injection of bevacizumab (Avastin)
Region
| Japan |
Condition
Condition
diabetic retinopathy central retinal vein occulusion, neovascular glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
study for efficacy and safety of intravitreal
injection of bevacizumab (avastin) for retinal disease and
neovascular glaucoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fundus findings
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
One intravitreal injection of bevacizumab (Avastin)
2.5mg.
Evaluate efficacy and safety at one month and three
months after 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
diabetic retinopathy, central retinal vein occulusion,
neovascular glaucoma
Key exclusion criteria
history of ontraocular operation within one month
ocular infection
ocular inflammation
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Yamazaki |
Organization
National Center for Global Health and
Medicine, Kohnodai Hospital
Division name
Department of Ophthalmology
Zip code
Address
1-7-1 Kohnodai 272-8619 Ichikawa,Japan
TEL
0474848785
yamazaki@hospk.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Yamazaki |
Organization
National Center for Global Health and Medicine, Kohnodai Hospital
Division name
Department of Ophthalmology
Zip code
Address
1-7-1 Kohnodai 272-8619 Ichikawa, Japan
TEL
0474848785
Homepage URL
yamazaki@hospk.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and
Medicine, Kohnodai Hospital
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and
Medicine
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
| 2013 | Year | 11 | Month | 08 | 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
Intravitreal injection of bevacizumab (avastin) has performed for five patients with retinal disease. All of five cases showed thinning of the retinal thickness. Neither general or local adverse events was found.
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
| 2012 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 14 | Day |
Other
Other related information
None
Management information
Registered date
| 2013 | Year | 11 | Month | 08 | Day |
Last modified on
| 2016 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014320
