UMIN-CTR Clinical Trial

Basic information
Public title	Study of effects on the retina morphological changes and vision of Aflibercept intravitreal injection in patients with macular edema due to central retinal vein occlusion.
Acronym	Study of effects of Aflibercept in patients with macular edema due to central retinal vein occlusion.
Scientific Title	Study of effects on the retina morphological changes and vision of Aflibercept intravitreal injection in patients with macular edema due to central retinal vein occlusion.
Scientific Title:Acronym	Study of effects of Aflibercept in patients with macular edema due to central retinal vein occlusion.
Region	Japan

Condition
Condition	For recurrent or persistent macular edema due to central retinal vein occlusion of the following anti
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Aflibercept intravitreal injection, central retinal thickness, foveal choroidal thickness, exudative changes, retinal blood flow to observe the effect on the change
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.The improvement rate of best corrected visual acuity at six months after the Aflibercept injection. 2.Presence or absence of exudative change, the changes of central retinal thickness and foveal choroidal thickness by OCT at 6 and 12 months after the Aflibercept injection.
Key secondary outcomes	1.The retinal blood flow changes measureed by LSFG at 6 and 12 months after the Aflibercept injection. 2.Duration from Aflibercept injection to recurrence. 3.Adverse event

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 administration of Aflibercept(Genetical Recombination)(EYLEA)
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	1.Patients with macular edema due to central retinal vein occlusion. 2.Central retinal thickness-=>250&micro;m 3.Point visual acuity less than 0.9 4.Patients who had received treatment with bevacizumab or ranibizumab for macular edema due to central retinal vein occlusion. 5.Age of patients 20years of age or older at the time of acquisition agreement. 6.After receiving a sufficient explanation upon participation in this study,on a full understanding,patients who obtained the document voluntary consent of the patient himself
Key exclusion criteria	1.Patients who underwent the pan-retinal photocoagulation within 3 months. 2.Patients who underwent photocoagulation treatment for macular edema within 3 months. 3.Patients treated with steroids to intraocular within 3 months. 4.The patients with a history of hypersensitivity to the study drug. 5.Patients who developed heart and cerebrovascular disease severe within 6 months. 6.Patients attending physician was deemed inappropriate as a subject.
Target sample size	30

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takashi Kitaoka
Organization	Nagasaki University Hospital
Division name	Ophthalmology
Zip code
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7345
Email	tkitaoka@nagasaki-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Makiko Matsumoto
Organization	Nagasaki University Hospital
Division name	Ophthalmology
Zip code
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7345
Homepage URL
Email	makimaki@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
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)

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

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 14 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	2014 Year 05 Month 01 Day
Date of IRB	2014 Year 03 Month 25 Day
Anticipated trial start date	2014 Year 06 Month 16 Day
Last follow-up date	2018 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	2014 Year 05 Month 30 Day
Last modified on	2019 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016430