UMIN-CTR Clinical Trial

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