UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020467 |
|---|---|
| Receipt number | 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 16:50:24 |
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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
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
tkitaoka@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023650
