UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Title of the study (Brief title)	Efficacy of intravitreal injection of aflibercept for retinal vein occlusion
Region	Japan

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

Objectives
Narrative objectives1	Evaluation of the efficacy and prediction of the visual prognosis concerning intravitreal injection of aflibercept for retinal vein occlusion
Basic objectives2	Others
Basic objectives -Others	Analysis of the association between the pathology and the factor of aqueous humor in eyes with retinal vein occlusion
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Analysis of the factor concerning the variation of best-corrected visual acuity 1 year after the first intravitreal injection
Key secondary outcomes	Analysis of the factor concerning the variation of best-corrected visual acuity and the regression of macular edema 2 year after the first intravitreal injection

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	interavitreal injection of 2.0mg of aflibercept
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with visual impairments due to macular edema associated with retinal vein oclusion
Key exclusion criteria	Patients with difficulty in intravitreal injection and examination because of mental retardation or dementia
Target sample size	50

Research contact person
Name of lead principal investigator	Tsujikawa Akitaka
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3248
Email	tujikawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Yuki Muraoka
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Ophthalmology and Visual Sciences
Address	54 Shougoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3248
Homepage URL
Email	muraoka@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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	2014 Year 09 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 09 Month 08 Day
Anticipated trial start date	2014 Year 09 Month 08 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	2014 Year 09 Month 15 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017632