UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of vascular endothelial growth factor taking tube shunt for neovascular glaucoma
Title of the study (Brief title)	The effect of VEGF taking tube shunt for NVG
Region	Japan

Condition
Condition	neovascular glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of tube shunt by observing the change of VEGF concentration of aqueous humor with neovascular glaucoma
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the concentration of aqueous humor VEGF
Key secondary outcomes	intra ocular pressure visual acuity

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	The diagnosis of neovascular glaucoma IOP higher than 21mmHg under full doze medication Indication of tube shunt The patient taking informed consent
Key exclusion criteria	S.L(-) The past history of any glaucoma operation The past history of any glaucoma except NVG The past history of anti VEGF therapy within one month The past history of constitutional symptom
Target sample size	20

Research contact person
Name of lead principal investigator	Inazaki Hiroshi
Organization	Yokohama City University Center Hospital
Division name	Opthalmology
Address	Urafune 4-57 Minami Yokohama Kanagawa Japan
TEL	045-261-5656
Email	ojionobao@yahoo.co.jp

Public contact
Name of contact person	Inazaki Hiroshi
Organization	Yokohama City University Center Hospital
Division name	the department of opthalmology
Address	Urafune 4-57 Minami Yokohama Kanagawa Japan
TEL	045-261-5656
Homepage URL
Email	ojionobao@yahoo.co.jp

Sponsor
Institute	Yokohama City university center hospital the department of opthalmology
Institute
Department

Funding Source
Organization	Yokohama City University
Organization
Division
Category of Funding Organization	Other
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	横浜市立大学附属市民総合医療センター

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 25 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 02 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 25 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	Partially published
URL releasing results
Results
Other related information	the observation of the changing of aqueous humor VEGF for six months after tube shunt operation.

Management information
Registered date	2015 Year 07 Month 24 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021309