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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006573
Receipt No. R000007781
Scientific Title The efficacy of Bromfenac sodium after intravitreal injection of Ranibizumab for age-related macular degeneration
Date of disclosure of the study information 2011/10/18
Last modified on 2015/10/19

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Basic information
Public title The efficacy of Bromfenac sodium after intravitreal injection of Ranibizumab for age-related macular degeneration
Acronym the efficacy of Bromfenac after injection of Ranibizumab for AMD
Scientific Title The efficacy of Bromfenac sodium after intravitreal injection of Ranibizumab for age-related macular degeneration
Scientific Title:Acronym the efficacy of Bromfenac after injection of Ranibizumab for AMD
Region
Japan

Condition
Condition age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the efficacy of topical bromfenac as an adjunctive therapy for patients with age-related macular degeneration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity, fundus examination including FA, IA and optical coherence tomography(OCT) , number of intravitreal injection
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 cases with age-related macular degeneration
Key exclusion criteria subjects with systemic risk factors
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidetoshi Yamashita
Organization Yamagata University Hospital
Division name Department of Ophthalmology
Zip code
Address 2-2-2 Iidanishi Yamagata
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shion Haneda
Organization Yamagata University Hospital
Division name Department of Ophthalmology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Yamagata University Hospital
Institute
Department

Funding Source
Organization Yamagata University Hospital
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
Email

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 10 Month 18 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 Terminated
Date of protocol fixation
2011 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
2014 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information public recruiting

Management information
Registered date
2011 Year 10 Month 18 Day
Last modified on
2015 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007781

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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