UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001546 |
|---|---|
| Receipt number | R000001860 |
| Scientific Title | Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on macular edema secondary to branch retinal vein occlusion |
| Date of disclosure of the study information | 2008/12/02 |
| Last modified on | 2008/12/02 08:38:22 |
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Basic information
Public title
Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on macular edema secondary to branch retinal vein occlusion
Acronym
Comparative study of Be and TA on BRVO
Scientific Title
Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on macular edema secondary to branch retinal vein occlusion
Scientific Title:Acronym
Comparative study of Be and TA on BRVO
Region
| Japan |
Condition
Condition
Macular edema secondary to branch retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of an intravitral injection of bevacizumab with that of triamcinolone acetonide for macular edema secondary to branch retinal vein occlusion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
variation on a logarithm of the minimum angle of resolution and variation on a central retinal thickness 1 month, 3 months, 6 months, 9 months, and 12 months after intravitreal injection.
Key secondary outcomes
fluorescin angiography before and 1 month, 3 months, 6 months, 9 months, and 12 months after intravitreal injection.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
duration: 12 months
quantity: bevacizumab 1.25 mg
number: no addition injection 3 months after primary injection and addition injection if the visual acuity decrease or the central retinal thicknes increase more than 100 micro meter.
Interventions/Control_2
duration: 12 months
quantity: triamcinolone acetonide 20 mg
number: no addition injection 3 months after primary injection and addition injection if the visual acuity decrease or the central retinal thicknes increase more than 100 micro meter.
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
visual acuity less than 0.5
central retinal thickness more than 300 micro meter
Key exclusion criteria
glaucoma
ocular pressure more than 21 mmHg
inflammation disease
diabetic retinopathy
history of steroid therapy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahito Ohji |
Organization
Shiga University of Medical Science
Division name
department of Ophthalmology
Zip code
Address
Seta Tukinowacho, Otsu, Shiga
TEL
077-548-2276
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Sawada |
Organization
Shiga University of Medical Science
Division name
department of Ophthalmology
Zip code
Address
Seta Tukinowacho, Otsu, Shiga
TEL
077-548-2276
Homepage URL
http://www.shiga-med.ac.jp/
l-eye@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science, department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2008 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Date of protocol fixation
| 2006 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 12 | Month | 02 | Day |
Last modified on
| 2008 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001860
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
