UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002854 |
|---|---|
| Receipt number | R000002691 |
| Scientific Title | Evaluation of efficacy of topical bromfenac (0.09%) as an adjunctive therapy for patients with neovascular age-related macular degeneration |
| Date of disclosure of the study information | 2009/12/07 |
| Last modified on | 2011/12/07 16:43:22 |
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Basic information
Public title
Evaluation of efficacy of topical bromfenac (0.09%) as an adjunctive therapy for patients with neovascular age-related macular degeneration
Acronym
Efficacy of topical bromfenac for exudative age-related macular degeneration
Scientific Title
Evaluation of efficacy of topical bromfenac (0.09%) as an adjunctive therapy for patients with neovascular age-related macular degeneration
Scientific Title:Acronym
Efficacy of topical bromfenac for exudative age-related macular degeneration
Region
| Japan |
Condition
Condition
exudative age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of topical bromfenac (0.09%) as an adjunctive therapy to anti-VEGF therapy for patients with neovascular age-related macular degeneration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
total number of injections of ranibizumab during 6 months' follow-up
Key secondary outcomes
the rate of eyes with persistent leakage from choroidal neovascularization on fluorescein angiography
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
topical bromfenac as an adjunctive therapy to intravitreal injection of ranibizumab
Interventions/Control_2
topical artificail tears as the sham of blomfenac to intravitreal injection of ranibizumab
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
treatment naive age-related macular degeneration with subfoveal choroidal neovascularization with visual acuity from 0.1 to 0.8
Key exclusion criteria
choroidal neovascularization secondary to pathorogical myopia or other diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumi Gomi |
Organization
Osaka University Medical School
Division name
Dept. of Ophthalmology
Zip code
Address
2-2, Yamadaoka, Suita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumi Gomi |
Organization
Osaka University Medical School
Division name
Dept. of Ophthalmology
Zip code
Address
TEL
06-6879-3456
Homepage URL
fgomi@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Osaka University Medical School
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co. LTD
Organization
Division
Category of Funding Organization
Profit 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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 07 | 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 | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 07 | Day |
Last modified on
| 2011 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002691
