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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005254
Receipt No. R000006251
Scientific Title Subtenon injection of bevacizumab for retinal vein occulusion
Date of disclosure of the study information 2011/03/16
Last modified on 2012/09/16

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Basic information
Public title Subtenon injection of bevacizumab for retinal vein occulusion
Acronym Subtenon injection of bevacizumab for retinal vein occulusion
Scientific Title Subtenon injection of bevacizumab for retinal vein occulusion
Scientific Title:Acronym Subtenon injection of bevacizumab for retinal vein occulusion
Region
Japan

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

Objectives
Narrative objectives1 To examine the efficacy of subtennon injection, safer than intravitreous injection, of bevacizumab for macular edema associated with retinal vein occulusion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes retinal thickness, visual acuity, count of injection
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
30 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with macular edema.
Not treated or more than 3 months passed after the other teatment.
Key exclusion criteria Post vitrectomy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koto
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of Ophthalmology, Keio University School of Medicine
Institute
Department

Funding Source
Organization None
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
2011 Year 03 Month 16 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 Preinitiation
Date of protocol fixation
2011 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 03 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 The difference of the efficasy between two delivery method.
Retrospective study.
Randam sample.

Management information
Registered date
2011 Year 03 Month 16 Day
Last modified on
2012 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006251

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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