UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012188 |
|---|---|
| Receipt number | R000013861 |
| Scientific Title | Establishment of a proper use of ranibizumab for the macular edema in retinal vein occlusion |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2013/10/31 20:28:04 |
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Basic information
Public title
Establishment of a proper use of ranibizumab for the macular edema in retinal vein occlusion
Acronym
Establishment of a proper use of ranibizumab for RVO
Scientific Title
Establishment of a proper use of ranibizumab for the macular edema in retinal vein occlusion
Scientific Title:Acronym
Establishment of a proper use of ranibizumab for RVO
Region
| Japan |
Condition
Condition
Retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of a proper use of ranibizumab for the macular edema in retinal vein occlusion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
central retinal thickness
visual acuity
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Three loading doses of intravitreal injection of ranibizumab at monthly interval followed by PRN
Interventions/Control_2
A single dose of intravitreal injection of ranibizumab followed by PRN
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)40 years of age or older
2)Person can understand the informed consent.
3)Three is vision loss due to macular edema due to retinal vein occlusion.
4)Three is no other eye disease that affects the central vision and visual acuity.
Key exclusion criteria
1) A history of cerebral hemorrhage and cerebral infection.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimitsu Ishiguro |
Organization
Kansai Medical University
Division name
Departmant of opthalmology
Zip code
Address
2-5-1Shinmachi,Hirakata, Japan
TEL
072-804-0101
ishigurt@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshimitsu Ishiguro |
Organization
Kansai Medical University
Division name
Departmant of opthalmology
Zip code
Address
2-5-1Shinmachi,Hirakata, Japan
TEL
072-804-0101
Homepage URL
ishigurt@hirakata.kmu.ac.jp
Sponsor or person
Institute
Departmant of opthalmology,Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 20 | 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
| 2013 | Year | 10 | Month | 31 | Day |
Last modified on
| 2013 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013861
