UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the relationship between visual improvement with intravitreal injection of Ranibizumab and chorioretinal hemodynamics in retinal vein occlusion with macular edema
Title of the study (Brief title)	Ranibizumab and chorioretinal blood flow
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate treatment outcomes including BCVA, OCT-findings and chorioretinal hemodynamics by stratified analysis according to the first IVR treatment response on VA and CFT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Population of visual improvemnt after the first intravitreal injection of Ranibizumab.
Key secondary outcomes

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	Duration:12months Quantity:Ramibizumab 0.5mg/injection
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	Patients with macular edema due to retinal vein occlusion who visit Tokyo women's medical university Central foveal thickness over 250 micron. Visual acuity over 0.1
Key exclusion criteria	Othe ocular pathology Past history of brain and myocardial infarction. Uncontrolled hypertention. Anti-VEGF treatment for general diseases. Laser, Anti-VEGF, intravitreal injection of steroid and vitrectomy for ocular pathology.
Target sample size	40

Research contact person
Name of lead principal investigator	Tomohiro Iida
Organization	Tokyo women's Medical University
Division name	Department of Ophthalmology
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Email	iida@oph.twmu.ac.jp

Public contact
Name of contact person	Akiko Kogure
Organization	Tokyo women's Medical University
Division name	Department of Ophthalmology
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	kogure.akiko@twmu.ac.jp

Sponsor
Institute	Department of Ophthalmology, Tokyo women's Medical University
Institute
Department

Funding Source
Organization	Novartis Pharmaceuticals Japan
Organization
Division
Category of Funding Organization	Profit organization
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	2015 Year 11 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 11 Month 25 Day
Anticipated trial start date	2013 Year 12 Month 15 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	2015 Year 11 Month 13 Day
Last modified on	2017 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022834