UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018407 |
|---|---|
| Receipt number | R000021309 |
| Scientific Title | The effect of vascular endothelial growth factor taking tube shunt for neovascular glaucoma |
| Date of disclosure of the study information | 2015/07/25 |
| Last modified on | 2017/02/20 16:58:03 |
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Basic information
Public title
The effect of vascular endothelial growth factor taking tube shunt for neovascular glaucoma
Acronym
The effect of VEGF taking tube shunt for NVG
Scientific Title
The effect of vascular endothelial growth factor taking tube shunt for neovascular glaucoma
Scientific Title:Acronym
The effect of VEGF taking tube shunt for NVG
Region
| Japan |
Condition
Condition
neovascular glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of tube shunt by
observing the change of VEGF concentration of aqueous humor with neovascular glaucoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the concentration of aqueous humor VEGF
Key secondary outcomes
intra ocular pressure
visual acuity
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
The diagnosis of neovascular glaucoma
IOP higher than 21mmHg under full doze medication
Indication of tube shunt
The patient taking informed consent
Key exclusion criteria
S.L(-)
The past history of any glaucoma operation
The past history of any glaucoma except NVG
The past history of anti VEGF therapy within one month
The past history of constitutional symptom
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Inazaki Hiroshi |
Organization
Yokohama City University Center Hospital
Division name
Opthalmology
Zip code
Address
Urafune 4-57 Minami Yokohama Kanagawa Japan
TEL
045-261-5656
ojionobao@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Inazaki Hiroshi |
Organization
Yokohama City University Center Hospital
Division name
the department of opthalmology
Zip code
Address
Urafune 4-57 Minami Yokohama Kanagawa Japan
TEL
045-261-5656
Homepage URL
ojionobao@yahoo.co.jp
Sponsor or person
Institute
Yokohama City university center hospital
the department of opthalmology
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
横浜市立大学附属市民総合医療センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the observation of the changing of aqueous humor VEGF for six months after tube shunt
operation.
Management information
Registered date
| 2015 | Year | 07 | Month | 24 | Day |
Last modified on
| 2017 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021309
| 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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| Registered date | File name |
