UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011094 |
|---|---|
| Receipt number | R000012810 |
| Scientific Title | Anti-vascular endothelial growth factor therapy for ocular diseases with neovascularization |
| Date of disclosure of the study information | 2013/07/15 |
| Last modified on | 2018/01/04 13:06:42 |
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Basic information
Public title
Anti-vascular endothelial growth factor therapy for ocular diseases with neovascularization
Acronym
Anti-VEGF therapy for ocular neovascularization
Scientific Title
Anti-vascular endothelial growth factor therapy for ocular diseases with neovascularization
Scientific Title:Acronym
Anti-VEGF therapy for ocular neovascularization
Region
| Japan |
Condition
Condition
choroidal neovascularization
diabetic retinopathy
retinal vein occulusion
neovascular glaucoma
retinopathy of prematurity
central serous chorioretinopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the efficacy and safety of intravitreal injection of bevacizumab for ocular neovascular diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Change in the visual acuity at 12 months from the initial treatment
Key secondary outcomes
The number of injections required over 12 months of follow-up. The presence or absence of complications.
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 of Bevacizumab
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The presence of active lesions of
1)myopic or secondary choroidal neovascularization
2)diabetic retinopathy
3)retinal vein occulusion
4)neovascular glaucoma
5)retinopathy of prematurity
6)central serous chorioretinopathy
Key exclusion criteria
1)high risk of stroke or myocardial infarction
2)systemic diseases with vessel occulusions
3)ocular infection
Target sample size
510
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Honda |
Organization
Kobe University Graduate school of Medicine
Division name
Ophthalmology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017 Japan
TEL
078-382-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Honda |
Organization
Kobe University Graduate school of Medicine
Division name
Ophthalmology
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017 Japan
TEL
078-382-5111
Homepage URL
Sponsor or person
Institute
Kobe University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate school of Medicine
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
| 2013 | Year | 07 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | 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
| 2013 | Year | 07 | Month | 02 | Day |
Last modified on
| 2018 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012810
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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