UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The intravitreal injection of Bevacizumab for retinopathy of prematurity
Title of the study (Brief title)	The intravitreal injection of Bevacizumab for ROP
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of intravitreal bevacizumab for retinopathy of prematurity
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fundus examination
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	Intravitreal injection of Bevacizumab
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with retinopathy of prematurity in Shiga University of Medical Science Hospital. The patients who selected an intravitreal injection of Bevacizumab (IVB) after enough explanation about retina photocoagulation and IVB. Written informed consent were obtained from the patients' parents in this study.
Key exclusion criteria	The patients with systemic risk factors
Target sample size	24

Research contact person
Name of lead principal investigator	Tomoaki Higashiyama
Organization	Shiga University of Medical Science
Division name	Department of Ophthalmology
Address	Seta, Tsukinowa-cho, Otsu, Shiga, Japan
TEL	0775482276
Email	higashi@belle.shiga-med.ac.jp

Public contact
Name of contact person	Tomoaki Higashiyama
Organization	Shiga University of Medical Science
Division name	Department of Ophthalmology
Address	Seta, Tsukinowa-cho, Otsu, Shiga, Japan
TEL	0775482276
Homepage URL
Email	higashi@belle.shiga-med.ac.jp

Sponsor
Institute	Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 30 Day
Anticipated trial start date	2014 Year 09 Month 30 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 08 Month 22 Day
Last modified on	2018 Year 12 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032923