UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluate the effect of intravitreal Bevacizumab injection for ocular proliferative diseases
Title of the study (Brief title)	Evaluate the effect of intravitreal Bevacizumab injection for ocular proliferative diseases
Region	Japan

Condition
Condition	choroidal neovascularization,proliferative diabetic retinopathy, central retinal vein occlusion neovascular glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the effect of intravitreal Bevacizumab injection for ocular proliferative diseases in Japanese
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visual acuity
Key secondary outcomes	Intra ocular pressure The degree of ischemia with fluorescein angiography Central retinal thickness

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	1,The administration of bevacizumab 1.25mg to target patient. 2,Compared a the administration Day1,Day7,Day28and prior to administration. -Visual acuity -Intra ocular pressure -Evaluation of new blood vessels -Central retinal thickness 3,After one month evaluation, and consider the administration if the improvement is you are not or exacerbation again.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Choroidal neovascularization -Patient there is no adaptation of photodynamic therapy. -Patients Bevacizumab administered is determined to more high effective 2.Proliferative diabetic retinopathy Central retinal vein occulusion -Patients improved even after the existing treatment or surgery therapy is not seen. 3.Neovascular glaucoma -The patient after the fallpan-retinal photocoagulation, the intraocular pressure even using the Ocular hypotensive agents does not.
Key exclusion criteria	Patients physician has judged inappropriate and comprehensive evaluation
Target sample size	90

Research contact person
Name of lead principal investigator	Takashi Kitaoka
Organization	Nagasaki University Hospital
Division name	Department of ophthalmology
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7345
Email	tkitaoka@nagasaki-u.ac.jp

Public contact
Name of contact person	Makiko Mtumoto
Organization	Nagasaki University Hospital
Division name	Department of ophthalmology
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7345
Homepage URL
Email	tkitaoka@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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	2016 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 07 Month 11 Day
Anticipated trial start date	2008 Year 08 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	2016 Year 01 Month 07 Day
Last modified on	2016 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023650