UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014338 |
|---|---|
| Receipt number | R000016635 |
| Scientific Title | Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin) for intraocular neovascular disease and macular edema |
| Date of disclosure of the study information | 2014/06/25 |
| Last modified on | 2017/01/29 15:34:28 |
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Basic information
Public title
Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin) for intraocular neovascular disease and macular edema
Acronym
Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin)
Scientific Title
Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin) for intraocular neovascular disease and macular edema
Scientific Title:Acronym
Clinical study to examine the efficacy of the intravitreal injection of anti-VEGF antibody (Avastin)
Region
| Japan |
Condition
Condition
Ophthalmic neovascular disease
Diabetic retinopathy
Retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A purpose of this study is to examine the efficacy of intraocular bevacizumab for ophthalmic neovascular disease and macular edema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ocular fundus
Key secondary outcomes
Visual acuity
Optical coherence tomography
Fluorescein angiography
Improvement of visual field
Improvement of intraocular pressure
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 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Ophthalmic neovasular disease
2) Diabetic retinopathy
3) Retinal vein occlusion
4) Patient 20 years or older at the time of the agreement acquisition
5) The patient that understands this study enough and the agreement in the document by the free will was provided after having received enough explanation
Key exclusion criteria
1) The patient who has difficulty in observation of the fundus for high cataract, corneal clouding
2) Patient younger than 20 years
3) The patient who received other study medication or other clinical experimental medicine within three months before this medication start
4) In addition, the patient who judged an examination responsibility (allotment) doctor to be inappropriate as a subject
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Yamamoto |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
TEL
043-222-7171
shuyama@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Tatsumi |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan
TEL
043-222-7171
Homepage URL
newyear98mt@yahoo.co.jp
Sponsor or person
Institute
Department of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 06 | Month | 25 | 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
| 2006 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 06 | Month | 21 | 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
| 2014 | Year | 06 | Month | 22 | Day |
Last modified on
| 2017 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016635
