UMIN-CTR Clinical Trial

Basic information
Public title	Combination therapy of intravitreal aflibercept and topical bromfenac for RVO
Acronym	Combination therapy of IVA and bromfenac
Scientific Title	Combination therapy of intravitreal aflibercept and topical bromfenac for RVO
Scientific Title:Acronym	Combination therapy of IVA and bromfenac
Region	Japan

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

Objectives
Narrative objectives1	We examined change of the therapeutic effect and the injection number by combination therapy with intravitreal aflibercept and topical bromfenac.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual acuity at the time of 12 month from injection
Key secondary outcomes	central macula thickness at the time of 12 month from injection, injection number during 12 months

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	use of topical bromfenac
Interventions/Control_2	use of artificial lacrimal fluid
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)The patients who received enough explanation about the purpose of this study, was obtained its consent 2)the patients who had macula edema due to retinal vein occlusion from the onset of less than 12 months
Key exclusion criteria	1) The patient who has difficulty in periodical going to hospital. 2)The patients who have had vitrectomy surgery or anti-VEGF injection. 3)The patient who received intraocular operation within three months before first injection. 4)The patient that it was judged to be inappropriate as an object of this study. 5)The patients who had other disease which induce visual disorder.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Yoshihito Middle name Last name Sakanishi
Organization	Juntendo Urayasu Hospital
Division name	Ophthalmology
Zip code	279-0021
Address	Tomioka 2-1-1 , Urayasu city, Chiba
TEL	047-353-3111
Email	ysakani@juntendo.ac.jp

Public contact
1st name of contact person	1st name Yoshihito Middle name Last name Sakanishi
Organization	Juntendo Urayasu Hospital
Division name	Ophthalmology
Zip code	279-0021
Address	Tomioka 2-1-1 , Urayasu city, Chiba
TEL	047-353-3111
Homepage URL
Email	ysakani@juntendo.ac.jp

Sponsor
Institute	Juntendo Urayasu Hospital
Institute
Department

Funding Source
Organization	Juntendo University Urayasu Hospital
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	Juntendo University Urayasu Hospital
Address	Tomioka2-1-1, Urayasu city,Chiba
Tel	047-353-3111
Email	ysakani@juntendo.ac.jp

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	2016 Year 08 Month 01 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	40
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	2016 Year 04 Month 01 Day
Date of IRB	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 07 Month 02 Day
Last modified on	2019 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026487