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Recruitment status Completed
Unique ID issued by UMIN UMIN000012248
Receipt No. R000014320
Official scientific title of the study Study for efficacy and safety of intravitreal injection of bevacizumab (Avastin)
Date of disclosure of the study information 2013/11/08
Last modified on 2016/06/20

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Basic information
Official scientific title of the study Study for efficacy and safety of intravitreal
injection of bevacizumab (Avastin)
Title of the study (Brief title) Study for efficacy and safety of intravitreal
injection of bevacizumab (Avastin)
Region
Japan

Condition
Condition diabetic retinopathy central retinal vein occulusion, neovascular glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 study for efficacy and safety of intravitreal
injection of bevacizumab (avastin) for retinal disease and
neovascular glaucoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes fundus findings
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 One intravitreal injection of bevacizumab (Avastin)
2.5mg.
Evaluate efficacy and safety at one month and three
months after injection.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria diabetic retinopathy, central retinal vein occulusion,
neovascular glaucoma
Key exclusion criteria history of ontraocular operation within one month
ocular infection
ocular inflammation
Target sample size 20

Research contact person
Name of lead principal investigator Hiroko Yamazaki
Organization National Center for Global Health and
Medicine, Kohnodai Hospital
Division name Department of Ophthalmology
Address 1-7-1 Kohnodai 272-8619 Ichikawa,Japan
TEL 0474848785
Email yamazaki@hospk.ncgm.go.jp

Public contact
Name of contact person Hiroko Yamazaki
Organization National Center for Global Health and Medicine, Kohnodai Hospital
Division name Department of Ophthalmology
Address 1-7-1 Kohnodai 272-8619 Ichikawa, Japan
TEL 0474848785
Homepage URL
Email yamazaki@hospk.ncgm.go.jp

Sponsor
Institute National Center for Global Health and
Medicine, Kohnodai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization National Center for Global Health and
Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 11 Month 08 Day

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 11 Month 15 Day
Anticipated trial start date
2012 Year 12 Month 20 Day
Last follow-up date
2014 Year 05 Month 14 Day
Date of closure to data entry
2014 Year 05 Month 14 Day
Date trial data considered complete
2014 Year 05 Month 14 Day
Date analysis concluded
2014 Year 05 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results Intravitreal injection of bevacizumab (avastin) has performed for five patients with retinal disease. All of five cases showed thinning of the retinal thickness. Neither general or local adverse events was found.
Other related information None

Management information
Registered date
2013 Year 11 Month 08 Day
Last modified on
2016 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014320


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