UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intravitreal injection of anti vascular endothelial growth factor agent, Lucentis (ranibizumab), for the treatment of retinopathy of prematurity
Title of the study (Brief title)	IVR for ROP
Region	Japan

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

Objectives
Narrative objectives1	we investigate VEGF concentration of serous and aqueous humor before and after intravitreal injecion of Lucentis to establish effect and safety of Lucentis for ROP. we will compare the result of Avastin injection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	prevention of retinal detachment serous VEGF concentration
Key secondary outcomes	visual acuity

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 injection of ranibizumab
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	0 years-old <=
Age-upper limit	0 years-old >=
Gender	Male and Female
Key inclusion criteria	severe cases of retinopathy of prematurity that are not controled after laser photocoagulation
Key exclusion criteria	inflammation around the eye
Target sample size	30

Research contact person
Name of lead principal investigator	Norie Nonobe
Organization	Nagoya auniversity hospital
Division name	ophthalmology
Address	65 tsurumai syowa-ku nagoya city
TEL	052-744-2275
Email	nonobe@med.nagoya-u.ac.jp

Public contact
Name of contact person	Norie Nonobe
Organization	Nagoya university hospital
Division name	ophthalmology
Address	65 tsurumai syowa-ku nagoya city
TEL	052-744-2275
Homepage URL
Email	nonobe@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University hospital ophtalmoligy
Institute
Department

Funding Source
Organization	KAKENHI
Organization
Division
Category of Funding 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	名古屋大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 09 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date	2019 Year 06 Month 30 Day
Date of closure to data entry	2019 Year 06 Month 30 Day
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	2014 Year 05 Month 16 Day
Last modified on	2017 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016281