UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin) for intraocular neovascular disease and macular edema
Title of the study (Brief title)	Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin)
Region	Japan

Condition
Condition	Ophthalmic neovascular disease Diabetic retinopathy Retinal vein occlusion
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A purpose of this study is to examine the efficacy of intraocular bevacizumab for ophthalmic neovascular disease and macular edema
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ocular fundus
Key secondary outcomes	Visual acuity Optical coherence tomography Fluorescein angiography Improvement of visual field Improvement of intraocular pressure

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	intravitreal bevacizumab
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	1) Ophthalmic neovasular disease 2) Diabetic retinopathy 3) Retinal vein occlusion 4) Patient 20 years or older at the time of the agreement acquisition 5) The patient that understands this study enough and the agreement in the document by the free will was provided after having received enough explanation
Key exclusion criteria	1) The patient who has difficulty in observation of the fundus for high cataract, corneal clouding 2) Patient younger than 20 years 3) The patient who received other study medication or other clinical experimental medicine within three months before this medication start 4) In addition, the patient who judged an examination responsibility (allotment) doctor to be inappropriate as a subject
Target sample size	3000

Research contact person
Name of lead principal investigator	Shuichi Yamamoto
Organization	Chiba University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
TEL	043-222-7171
Email	shuyama@faculty.chiba-u.jp

Public contact
Name of contact person	Tomoaki Tatsumi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Science
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
TEL	043-222-7171
Homepage URL
Email	newyear98mt@yahoo.co.jp

Sponsor
Institute	Department of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chiba University Hospital
Organization
Division
Category of Funding Organization
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	2014 Year 06 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 05 Month 15 Day
Anticipated trial start date	2006 Year 06 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 06 Month 22 Day
Last modified on	2017 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016635