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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019771
Receipt No. R000022834
Scientific Title Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema
Date of disclosure of the study information 2015/11/13
Last modified on 2017/09/19

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Basic information
Public title Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema
Acronym Ranibizumab and chorioretinal blood flow
Scientific Title Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema
Scientific Title:Acronym Ranibizumab and chorioretinal blood flow
Region
Japan

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

Objectives
Narrative objectives1 This study aims to evaluate treatment outcomes including BCVA, OCT-findings and chorioretinal hemodynamics by stratified analysis according to the first IVR treatment response on VA and CFT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Population of visual improvemnt after the first intravitreal injection of Ranibizumab.
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 Duration:12months
Quantity:Ramibizumab 0.5mg/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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with macular edema due to retinal vein occlusion who visit Tokyo women's medical university
Central foveal thickness over 250 micron.
Visual acuity over 0.1
Key exclusion criteria Othe ocular pathology
Past history of brain and myocardial infarction.
Uncontrolled hypertention.
Anti-VEGF treatment for general diseases.
Laser, Anti-VEGF, intravitreal injection of steroid and vitrectomy for ocular pathology.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomohiro Iida
Organization Tokyo women's Medical University
Division name Department of Ophthalmology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email iida@oph.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Kogure
Organization Tokyo women's Medical University
Division name Department of Ophthalmology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email kogure.akiko@twmu.ac.jp

Sponsor
Institute Department of Ophthalmology, Tokyo women's Medical University
Institute
Department

Funding Source
Organization Novartis Pharmaceuticals Japan
Organization
Division
Category of Funding Organization Profit 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
2015 Year 11 Month 13 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 Open public recruiting
Date of protocol fixation
2013 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 15 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
2015 Year 11 Month 13 Day
Last modified on
2017 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022834

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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