UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003646 |
|---|---|
| Receipt number | R000004416 |
| Scientific Title | Intraocular dynamics of vascular endothelial growth factor levels in patients with neovascular glaucoma |
| Date of disclosure of the study information | 2010/05/24 |
| Last modified on | 2011/11/27 16:13:25 |
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Basic information
Public title
Intraocular dynamics of vascular endothelial growth factor levels in patients with neovascular glaucoma
Acronym
Aqueous humor VEGF levels before and after intravitreal bevacizumab for neovascular glaucoma
Scientific Title
Intraocular dynamics of vascular endothelial growth factor levels in patients with neovascular glaucoma
Scientific Title:Acronym
Aqueous humor VEGF levels before and after intravitreal bevacizumab for neovascular glaucoma
Region
| Japan |
Condition
Condition
neovascular glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes of aqueous humor VEGF levels before and after intravitreal bevacizumab and elucidate the optimal dosage of bevacizumab for treating neovascular glaucoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of aqueous humor VEGF concentrations and intraocular pressures beore and after the high- and low-doses of intravitreal bevacizumab
Key secondary outcomes
Clinical evaluation of the changes in iris and angle neovascularization before and after the high- and low-doses of intravitreal bevacizumab
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravitreal injection of 1.0-mg bevacizumab
Interventions/Control_2
intravitreal injection of 0.1-mg bevacizumab
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
Eyes with neovascular glaucoma scheduled for intravitreal injection of bevacizumab
Key exclusion criteria
Eyes with a past history of intravitreal pharmacotherapy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Oshima |
Organization
Osaka University Medical School
Division name
Ophthalmology
Zip code
Address
2-2 Yamadaoka, Suita 5650871, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Medical School
Division name
Ophthalmology
Zip code
Address
TEL
06-6879-3456
Homepage URL
Sponsor or person
Institute
Osaka University Hospital, Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Osaka University Medical School
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
| 2010 | Year | 05 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.liebertonline.com/doi/abs/10.1089/jop.2011.0059
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
| 2007 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 21 | Day |
Last modified on
| 2011 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004416
