UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Rondomized prospective trials of intravitreal bevacizumab alone versus combined with photocoagulation for ischmic lesion in retinal venous occlusion.
Title of the study (Brief title)	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	Yoshihiro Takamura
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Department of Ophthalmology
Address	23-3 Matsuoka, Eiheiji, Yoshida, Fukui, Japan.
TEL	0776-61-8403
Email	ytakamura@hotmail.com

Public contact
Name of contact person	Yoshihiro Takamura
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 12 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011361