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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009689
Receipt No. R000011361
Scientific Title Rondomized prospective trials of intravitreal bevacizumab alone versus combined with photocoagulation for ischmic lesion in retinal venous occlusion.
Date of disclosure of the study information 2013/01/10
Last modified on 2017/07/09

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Basic information
Public title Rondomized prospective trials of intravitreal bevacizumab alone versus combined with photocoagulation for ischmic lesion in retinal venous occlusion.
Acronym Combination therapy of bevacizumab injection and photocoagulation for BRVO
Scientific Title Rondomized prospective trials of intravitreal bevacizumab alone versus combined with photocoagulation for ischmic lesion in retinal venous occlusion.
Scientific Title:Acronym Combination therapy of bevacizumab injection and photocoagulation for BRVO
Region
Japan

Condition
Condition macular edema due to branch retinal vein occlusion
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of photocoagulation for nonperfusion area of branch retinal vein occlusion to prevent the recurrence of macular edema after intravitreal injection of bevacizumab.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Central retinal thickness at 3 months after the injection of bevacizumab.
Key secondary outcomes Best corrected visual acuity at 3 months after the injection of bevacizumab.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Photocoagulation for non-perfusion areas after injection of bevacizumab.
Interventions/Control_2 Injection of bevacizumab without photocoagulation.
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
35 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients diagnosed with branch retinal vein occlusion with macular edema were enrolled.

Patient who obtained agreement after enough explanation when participating in this study is received.
Key exclusion criteria History of ocular surgery, Ocular diseases except for branch retinal vein occlusion.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiro Takamura
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL 0776-61-8403
Email ytakamura@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Takamura
Organization Faculty of Medical Sciences, University of Fukui
Division name Department of Ophthalmology
Zip code
Address 23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL 0776618403
Homepage URL
Email ytakamura@hotmail.com

Sponsor
Institute Department of Ophthalmology, Faculty of Medical Sciences, University of Fukui
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
2013 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 12 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
2013 Year 01 Month 04 Day
Last modified on
2017 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=R000011361

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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