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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027243
Receipt No. R000031210
Scientific Title Anti-vascular endothelial growth factor therapy for ocular diseases of neovascularization
Date of disclosure of the study information 2017/05/04
Last modified on 2018/07/09

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Basic information
Public title Anti-vascular endothelial growth factor therapy for ocular diseases of neovascularization
Acronym Anti-VEGF therapy for ocular neovascularization
Scientific Title Anti-vascular endothelial growth factor therapy for ocular diseases of neovascularization
Scientific Title:Acronym Anti-VEGF therapy for ocular neovascularization
Region
Japan

Condition
Condition retinopathy of prematurity
neovascular glaucome
vasoproliferative tumor
choroidal neovascularization
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect and safety of bevacizumab therapy on ocular neovascular diseases.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of ocular blood flow at 1 week, 1 months and 3 months from the initial treatment.
Key secondary outcomes

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 injection of 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The presence of active ocular neovascularization.
Key exclusion criteria 1, high risk of stroke infarction
2, high risk of myocardial infarction
3, ocular infection
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Matsumoto
Organization School of Medicine Toho University
Division name Department of Ophthalmology
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541
TEL 81-3-3762-4151
Email matsu-t@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Matsumoto
Organization School of Medicine Toho University
Division name Department of Ophthalmology
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541
TEL 81-3-3762-4151
Homepage URL
Email matsu-t@med.toho-u.ac.jp

Sponsor
Institute School of Medicine Toho University
Institute
Department

Funding Source
Organization Self funding
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
2017 Year 05 Month 04 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
2015 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 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
2017 Year 05 Month 03 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031210

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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