UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the efficacy, safety and injection interval of intravitreal injection of ranibizumab for retinal vein occlusion
Acronym	intravitreal injection of ranibizumab for retinal vein occlusion
Scientific Title	Evaluation of the efficacy, safety and injection interval of intravitreal injection of ranibizumab for retinal vein occlusion
Scientific Title:Acronym	intravitreal injection of ranibizumab for retinal vein occlusion
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the efficacy, safety and injection interval of intravitreal injection of ranibizumab for retinal vein occlusion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Variation on a logarithm of the minimum angle of resolution at 12 months after the first intravitreal injection
Key secondary outcomes	The rate of complication at 12 months after the first intravitreal injection Variation on a central retinal thickness

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:12 months Quantity: ranibizumab 0.5 mg Bimonthly 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	Outpatients of Shiga University of Medical Science Hospital with retinal vein occlusion that are examined by angiography or checked retinal thickness.
Key exclusion criteria	severe renal disease unstable angina malignant arrhythmia history of brain infarction history of cerebral hemorrhage severe hypertension
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Masahito Ohji
Organization	Shiga University of Medical Science
Division name	Department of Ophthalmology
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga 520-2192, JAPAN
TEL	0775482276
Email	ohji@belle.shiga-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Yoshitsugu Saishin
Organization	Shiga University of Medical Science
Division name	Department of Ophthalmology
Zip code
Address	Seta Tsukinowa-cho, Otsu, Shiga 520-2192, JAPAN
TEL	0775482276
Homepage URL
Email	saishin@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	滋賀医科大学附属病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 15 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	Completed
Date of protocol fixation	2013 Year 09 Month 24 Day
Date of IRB	2013 Year 09 Month 24 Day
Anticipated trial start date	2013 Year 10 Month 01 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 15 Day
Last modified on	2019 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014074