UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Anti-vascular endothelial growth factor therapy for ocular diseases with neovascularization
Title of the study (Brief title)	Anti-VEGF therapy for ocular neovascularization
Region	Japan

Condition
Condition	choroidal neovascularization diabetic retinopathy retinal vein occulusion neovascular glaucoma retinopathy of prematurity central serous chorioretinopathy
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To demonstrate the efficacy and safety of intravitreal injection of bevacizumab for ocular neovascular diseases.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Change in the visual acuity at 12 months from the initial treatment
Key secondary outcomes	The number of injections required over 12 months of follow-up. The presence or absence of complications.

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 presence of active lesions of 1)myopic or secondary choroidal neovascularization 2)diabetic retinopathy 3)retinal vein occulusion 4)neovascular glaucoma 5)retinopathy of prematurity 6)central serous chorioretinopathy
Key exclusion criteria	1)high risk of stroke or myocardial infarction 2)systemic diseases with vessel occulusions 3)ocular infection
Target sample size	510

Research contact person
Name of lead principal investigator	Shigeru Honda
Organization	Kobe University Graduate school of Medicine
Division name	Ophthalmology
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017 Japan
TEL	078-382-5111
Email

Public contact
Name of contact person	Shigeru Honda
Organization	Kobe University Graduate school of Medicine
Division name	Ophthalmology
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017 Japan
TEL	078-382-5111
Homepage URL
Email

Sponsor
Institute	Kobe University Graduate school of Medicine
Institute
Department

Funding Source
Organization	Kobe University Graduate school of Medicine
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	2013 Year 07 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 06 Month 04 Day
Anticipated trial start date	2013 Year 07 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	2013 Year 07 Month 02 Day
Last modified on	2018 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012810