UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006968 |
|---|---|
| Receipt number | R000008227 |
| Scientific Title | Comparison of a loading regimen and a single-dose regimen of intravitreal ranibizumab in the treatment of neovascular age-related macular degeneration |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2011/12/28 01:47:33 |
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Basic information
Public title
Comparison of a loading regimen and a single-dose regimen of intravitreal ranibizumab in the treatment of neovascular age-related macular degeneration
Acronym
Necessity of the loading dose of intravitreal ranibizumab for neovascular AMD
Scientific Title
Comparison of a loading regimen and a single-dose regimen of intravitreal ranibizumab in the treatment of neovascular age-related macular degeneration
Scientific Title:Acronym
Necessity of the loading dose of intravitreal ranibizumab for neovascular AMD
Region
| Japan |
Condition
Condition
neovascular age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A loading regimen of three initial monthly intravitreal injections of ranibizumab has been recommended for treating neovascular age-related macular degeneration (AMD). However, no evidence supports the need for a loading regimen in all patients to achieve functional and morphologic retinal improvement. The purpose of this study was to compare a loading regimen with a single-dose regimen for treating AMD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Best-corrected visual acuities (BCVAs)
Key secondary outcomes
Central retinal thickness
Averaged injection number of intravitreal ranibizumab
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A single-dose regimen
Interventions/Control_2
A loading regimen
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
neovascular age-related macular degeneration with best-corrected visual acuity (BCVAs) of 0.15 to 1.30 in the LogMAR unit
Key exclusion criteria
previous treatments involving laser photocoagulation, intravitreal triamcinolone, intravitreal bevacizumab, or photodynamic therapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Yasukawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Ophthalmology and Visual Science
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
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
| 2011 | Year | 12 | Month | 28 | 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
| 2009 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | 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
| 2011 | Year | 12 | Month | 28 | Day |
Last modified on
| 2011 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008227
