UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	CORRELATION BETWEEN SHORT- AND LONG-TERM EFFECTS OF INTRAVITREAL RANIBIZUMAB THERAPY ON MACULAR EDEMA AFTER BRANCH RETINAL VEIN OCCLUSION
Title of the study (Brief title)	CORRELATION BETWEEN SHORT- AND LONG-TERM EFFECTS OF INTRAVITREAL RANIBIZUMAB THERAPY ON MACULAR EDEMA AFTER BRANCH RETINAL VEIN OCCLUSION
Region	Japan

Condition
Condition	BRANCH RETINAL VEIN OCCLUSION
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the correlation between the short- and long-term effects of intravitreal ranibizumab (IVR) on macular edema after branch retinal vein occlusion (BRVO).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoint was the change from baseline in the best-corrected visual acuity at 1 day and 6 months after the intravitreal ranibizumab injection.
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	intravitreal ranibizumab injection for 6 months
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	The inclusion criteria were the presence of macular edema that involved the fovea after development of BRVO before therapy (foveal thickness [FT] at baseline more than 300 microns), no history of IVR injection, and no history of other treatments for macular edema within the previous 3 months.
Key exclusion criteria	The exclusion criteria were the presence of other retinal diseases such as diabetic retinopathy and age-related macular degeneration.
Target sample size	25

Research contact person
Name of lead principal investigator	Yoshiro Minami
Organization	Nayoro city general hospital
Division name	medical examination section
Address	nishi 8 minami 7-1 nayoro hokkaido japan
TEL	0165433101
Email	y37373m@yahoo.co.jp

Public contact
Name of contact person	Yoshiro Minami
Organization	Nayoro city general hospital
Division name	medical examination section
Address	nishi 8 minami 7-1 nayoro hokkaido japan
TEL	0165433101
Homepage URL
Email	y37373m@yahoo.co.jp

Sponsor
Institute	Nayoro city general hospital
Institute
Department

Funding Source
Organization	Nayoro city general hospital
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	名寄市立総合病院

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 10 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 15 Day
Last modified on	2017 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030963