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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000895
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kumamoto University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001076

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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