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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013236
Receipt No. R000015446
Scientific Title changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion
Date of disclosure of the study information 2014/02/24
Last modified on 2016/08/29

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Basic information
Public title changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion
Acronym changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion
Scientific Title changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion
Scientific Title:Acronym changes in ocular blood flow and vascular endothelial factors and efficacy of treatment for patients with macular edema of retinal vein occlusion
Region
Japan

Condition
Condition retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of treatment with intravitreal anti-VEGF injection by measuring ocular blood flow and vascular endothelial factors in patients with macular edema of retinal vein occlusion.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Before and one month, three months after the 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
Maneuver
Interventions/Control_1 intravitreal injection and blood sampling
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 macular edema with retinal vein occlusion which have never been treated.
Key exclusion criteria macular edema with retinal vein occlusion which have ever been treated.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruyo Kida
Organization Osaka Medical College
Division name Ophthalmology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686
TEL 072-683-1221
Email kida_teruyo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teruyo Kida
Organization Osaka Medical College
Division name Outpatients clinic of Ophthalmology
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka 569-8686
TEL 072-683-1221
Homepage URL
Email kida_teruyo@yahoo.co.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Department of Ophthalmology, Osaka Medical College
Organization
Division
Category of Funding Organization Other
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 02 Month 24 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pubmed/27559424
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/27559424
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
2012 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2016 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015446

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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