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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014338
Receipt No. R000016635
Scientific Title Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin) for intraocular neovascular disease and macular edema
Date of disclosure of the study information 2014/06/25
Last modified on 2017/01/29

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Basic information
Public title Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin) for intraocular neovascular disease and macular edema
Acronym Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin)
Scientific Title Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin) for intraocular neovascular disease and macular edema
Scientific Title:Acronym 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
1st name
Middle name
Last name Shuichi Yamamoto
Organization Chiba University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Science
Zip code
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
1st name
Middle name
Last name Tomoaki Tatsumi
Organization Chiba University Graduate School of Medicine
Division name Department of Ophthalmology and Visual Science
Zip code
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)

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
2014 Year 06 Month 25 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 Completed
Date of protocol fixation
2006 Year 05 Month 15 Day
Date of IRB
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

Other
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

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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