UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013974 |
|---|---|
| Receipt number | R000011791 |
| Scientific Title | The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases. |
| Date of disclosure of the study information | 2014/05/19 |
| Last modified on | 2019/05/24 15:53:30 |
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Basic information
Public title
The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases.
Acronym
The effcet of intra-vitreal bevacizumab.
Scientific Title
The effect of intra-vitreal injection of bevacizumab for vascular endothelial factor-related intraocular diseases.
Scientific Title:Acronym
The effcet of intra-vitreal bevacizumab.
Region
| Japan |
Condition
Condition
choroidal neovascularization, retinal vein occlusion, diabetic retinopathy, diabetic maculopathy, neovascular glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the intravitreal bevacizumab for vascular endothelial factor-related intraocular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Varidation on the visula acuity at 1, 3, 6, 12 months after intravitreal injection
Key secondary outcomes
Examination of macular forrmation and thickness by optical coherence tomography
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 injection
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
Patients at Matsumoto Dental University with choroidal neovasucularization, retinal vein occlusion, diabetic retionopathy, uveitis, and neovascular glaucoma.
Key exclusion criteria
Patietns with uncontroled hypertension or with systemic risk factors of cerebral infarction or cardial infarction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kouichi |
| Middle name | |
| Last name | Ohta |
Organization
Matsumoto Dental Univeristy
Division name
Ophthalmology
Zip code
399-0781
Address
1780 Gobara, Hiooka, Shiojiri
TEL
0263-51-2360
ohta@p.mdu.ac.jp
Public contact
Name of contact person
| 1st name | Kouichi |
| Middle name | |
| Last name | Ohta |
Organization
Matsumoto Dental University
Division name
Ophthalmology
Zip code
399-0781
Address
1780 Gobara, Hirooka, Shiojiri
TEL
0263-51-2360
Homepage URL
ohta@po.mdu.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Matsumoto Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology,
Matsumoto Dental University
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
Matsumoto Dental University
Address
1780 Gobara, Hirooka, Shiojiri
Tel
0263-51-2188
info_kakenhi@po.mdu.ac.jp.
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
松本歯科大学病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 19 | 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
3
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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011791
