UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in retinal microcirculation after intravitreal aflibercept in eyes with macular edema secondory to branch retinal vein occlusion
Title of the study (Brief title)	Changes in retinal microcirculation after intravitreal aflibercept in eyes with macular edema secondory to 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 evaluate the effects of an intravitreal aflibercept (IVA) injection on the retinal microcirculation of eyes with macular edema secondary to a branch retinal vein occlusion (BRVO) by laser speckle flowgraphy(LSFG)
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood flow of retinochoroidal blood vessel
Key secondary outcomes	Choroidal vascular area Choroidal thickness Inra-ocular pressure

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	One dose of intravitreal aflibercept(2mg/0.05ml)
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Eyes with macular edema secondary to branch retinal vein occlusion
Key exclusion criteria	Presence of eye disease History of eye disease treatment
Target sample size	30

Research contact person
Name of lead principal investigator	Takeshi Iwase
Organization	Nagoya University School of Medicine
Division name	Department of Opthlamology
Address	Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL	052-744-2275
Email	tiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person	Yoshitaka Ueno
Organization	Nagoya University School of Medicine
Division name	Department of Opthalmology
Address	Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL	052-744-2275
Homepage URL
Email	ystk.imp@gmail.com

Sponsor
Institute	Nagoya University
Institute
Department

Funding Source
Organization	Nagoya University
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	2017 Year 07 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 07 Month 31 Day
Anticipated trial start date	2017 Year 08 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 07 Month 26 Day
Last modified on	2017 Year 07 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032477