UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000895 |
|---|---|
| Receipt number | R000001076 |
| Scientific Title | The study for surgical outcome of trabeculectomy for neovascular glaucomatous patients who received an additional bevacizumab treatment after the surgery. |
| Date of disclosure of the study information | 2007/11/19 |
| Last modified on | 2010/12/24 12:37:02 |
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Basic information
Public title
The study for surgical outcome of trabeculectomy for neovascular glaucomatous patients who received an additional bevacizumab treatment after the surgery.
Acronym
Surgical outcome in neovascular glaucomatous patients with bevacizumab after trabeculectomy.
Scientific Title
The study for surgical outcome of trabeculectomy for neovascular glaucomatous patients who received an additional bevacizumab treatment after the surgery.
Scientific Title:Acronym
Surgical outcome in neovascular glaucomatous patients with bevacizumab after trabeculectomy.
Region
| Japan |
Condition
Condition
Patients with neovascular glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether an additional bevacizumab treament improves surgical outcome of trabeculectomy for patients with neovascular glaucoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraocular pressure levels after an additional treatment of bevacizumab following trabeculectomy.
Key secondary outcomes
The size of filtrating bleb.
The inflammation in the anterior chamber
The concentrations of cytokines in the anterior chamber.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients are treated with an intravitreal injection of 1.25 mg bevacizumab (avastin) within 5 days before trabeculectomy, then treated with trabeculectomy. Then, they are treated with an intravitreal injection of 1.25 mg bevacizumab (Avastin), on 2 weeks after trabeculectomy.
Interventions/Control_2
Patients are treated with an intravitreal injection of 1.25 mg bevacizumab (avastin) within 5 days before trabeculectomy, then treated with trabeculectomy. Then, they are not treated with bevacizumab (Avastin).
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
Patients with neovascular glaucoma.
Intraocular pressure levels of higher than 21 mmHg before trabeculectomy.
Key exclusion criteria
Patients who have been previously treated with trabeculectomy.
Patients who had been treated with bevacizumab within recent 2 months.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaru Inatani |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-1-1 Honjo Kumamoto, 860-8556 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kumamoto University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-1-1-1 Honjo Kumamoto, 860-8556 Japan
TEL
Homepage URL
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
None
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 | 11 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 07 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 15 | Day |
Last modified on
| 2010 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001076
