UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006992 |
|---|---|
| Receipt number | R000008250 |
| Scientific Title | Evaluation of bevacizumab, pegaptanib and ranibizumab for intraocular neovasculalization and/or macular edema |
| Date of disclosure of the study information | 2011/12/30 |
| Last modified on | 2019/03/16 12:05:03 |
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Basic information
Public title
Evaluation of bevacizumab, pegaptanib and ranibizumab for intraocular neovasculalization and/or macular edema
Acronym
Evaluation of bevacizumab, pegaptanib and ranibizumab for intraocular neovasculalization and/or macular edema
Scientific Title
Evaluation of bevacizumab, pegaptanib and ranibizumab for intraocular neovasculalization and/or macular edema
Scientific Title:Acronym
Evaluation of bevacizumab, pegaptanib and ranibizumab for intraocular neovasculalization and/or macular edema
Region
| Japan |
Condition
Condition
diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, choroidal neovasucularization, neovascular maculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of intravitreal injection of anti-VEGF drugs for intraocular neovasculalization and/or macular edema
Basic objectives2
Safety,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 12 months after the first intravitreal injection
Key secondary outcomes
The rate of complication 12 months after the first intravitreal injection
Variation on a central retinal thickness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravitreal bevacizumab for treatment
Interventions/Control_2
Intravitreal pegaptanib for treatment
Interventions/Control_3
Intravitreal ranibizumab for treatment
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
Outpatients of Shiga University of Medical Science with intraocular neovasculalization or macular edema that are examined by angiography or checked retinal thickness.
Key exclusion criteria
severe glaucoma
unstable angina
malignant arrhythmia
anaphylaxis
Target sample size
80
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 Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitsugu Saishin |
Organization
Shiga University of Medical Science
Division name
Department of Ophthalmology
Zip code
Address
Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Department of Ophthalmology, Shiga University of Medical Science
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
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
滋賀医科大学附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 30 | 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
Ito Y, Saishin Y, Sawada O, et al. Comparison of single injection and three monthly injections of intravitreal bevacizumab for macular edema associated with branch retinal vein occlusion. Clin Ophthalmol 2015;9: 175-180.
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
| 2011 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008250
| 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 |
