UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Aflibercept treat and extend for macular edema secondary to branch retinal vein occlusion
Title of the study (Brief title)	Aflibercept treat and extend for 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 investigate best corrected visual acuity and retinal sensitivity at 12 months after intravitreal aflibercept treat and extend vs PRN for macular edema secondary to branch retinal vein occlusion
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in best corrected visual acuity at 12 months after intravitreal aflibercept
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	aflibercept treat and extend
Interventions/Control_2	aflibercept prn
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Naive BRVO 2.BCVA 0.1-1.0 3.Disease duration < 3 months 4.NPA< 5DD
Key exclusion criteria	1.Past history of vitrectomy or glaucoma surgery 2.Cataract surgery within 3 months 3.patients with diabetic retinopathy or central vein occlusion 4.IOP poor control
Target sample size	50

Research contact person
Name of lead principal investigator	Tsutomu Sakai
Organization	Jikei daisan hospital
Division name	Ophthalmology
Address	4-11-1 izsumihoncho, komae, Tokyo
TEL	0334801151
Email	tstmski@jikei.ac.jp

Public contact
Name of contact person	Tsutomu Sakai
Organization	Jikei daisan hospital
Division name	Ophthalmology
Address	4-11-1 izsumihoncho, komae, Tokyo
TEL	0334801151
Homepage URL
Email	tstmski@jikei.ac.jp

Sponsor
Institute	Jikei daisan hospital
Institute
Department

Funding Source
Organization	Bayer
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	2017 Year 04 Month 24 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 11 Month 14 Day
Anticipated trial start date	2017 Year 04 Month 24 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 04 Month 22 Day
Last modified on	2017 Year 04 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031059