UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intravitreal bevacizumab treatment for severe retinopathy of prematurity
Title of the study (Brief title)	Intravitreal bevacizumab treatment for severe retinopathy of prematurity
Region	Japan

Condition
Condition	severe retinopathy of prematurity
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Treatment for severe retinopathy of prematurity
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Regress the retinopathy of prematurity
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	Patients with severe retinopathy of prematurity which were ineffective by laser therapy.
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	Not applicable
Age-upper limit	1 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with severe retinopathy of prematurity which were ineffective by laser therapy.
Key exclusion criteria	Patients with retinopathy of prematurity which are treatable by laser therapy.
Target sample size	6

Research contact person
Name of lead principal investigator	Yasuhiro Ohkuma
Organization	The Jikei University School of Medicine
Division name	Ophthalmology
Address	3-25-8 Nishi-Shimbashi, Minato-ku Tokyo
TEL	03-3433-1111
Email	yookuma1110@gmail.com

Public contact
Name of contact person	Yasuhiro Ohkuma
Organization	The Jikei University School of Medicine
Division name	Ophthalmology
Address	3-19-18 Nishi-Shimbashi, Minato-ku Tokyo
TEL	03-3433-1111
Homepage URL
Email	yookuma1110@gmail.com

Sponsor
Institute	The Jikei University School of Medicine Department of Ophthalmology
Institute
Department

Funding Source
Organization	The Jikei University School of Medicine Department of Ophthalmology
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	東京慈恵会医科大学附属病院（東京）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 12 Month 09 Day
Anticipated trial start date	2012 Year 04 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	2015 Year 06 Month 29 Day
Last modified on	2017 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008484