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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020467
Receipt No. R000023650
Scientific Title Evaluate the effect of intravitreal Bevacizumab injection for ocular proliferative diseases
Date of disclosure of the study information 2016/02/01
Last modified on 2016/07/05

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Basic information
Public title Evaluate the effect of intravitreal Bevacizumab injection for ocular proliferative diseases
Acronym Evaluate the effect of intravitreal Bevacizumab injection for ocular proliferative diseases
Scientific Title Evaluate the effect of intravitreal Bevacizumab injection for ocular proliferative diseases
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Takashi Kitaoka
Organization Nagasaki University Hospital
Division name Department of ophthalmology
Zip code
Address 1-7-1 Sakamoto,Nagasaki
TEL 095-819-7345
Email tkitaoka@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Mtumoto
Organization Nagasaki University Hospital
Division name Department of ophthalmology
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 07 Month 11 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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