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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006869
Receipt No. R000006671
Scientific Title The study of effects of additional beraprost on the amelioration and retention of retinal and choroidal circulation after ranibizumab treatment in age-related macular degeneration.
Date of disclosure of the study information 2011/12/10
Last modified on 2011/12/10

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Basic information
Public title The study of effects of additional beraprost on the amelioration and retention of retinal and choroidal circulation after ranibizumab treatment in age-related macular degeneration.
Acronym The study of additional beraprost in age-related macular degeneration
Scientific Title The study of effects of additional beraprost on the amelioration and retention of retinal and choroidal circulation after ranibizumab treatment in age-related macular degeneration.
Scientific Title:Acronym The study of additional beraprost in age-related macular degeneration
Region
Japan

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

Objectives
Narrative objectives1 To assess the improvement and maintenance of circulation of retina and choroid with Beraprost sodium
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes after 6 months from beginning of the medication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Take orally of beraprost sodium 60 microgram per day for 6 months after surgery
Interventions/Control_2 No drug.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Intravireous injection of ranibizumab for age related macular degeneration monthly for 3 months and since then become composed.
Key exclusion criteria glaucoma,hypertension,past history or risk of stroke, bleeding, tendency of bleeding, other anticoagulant
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kitaoka
Organization Nagasaki university hospital
Division name Ophthalmology
Zip code
Address 1-7-1 Sakamoto Nagasaki City
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagasaki university hospital
Division name Ophthalmology
Zip code
Address
TEL 095-819-7345
Homepage URL
Email

Sponsor
Institute Nagasaki university
Institute
Department

Funding Source
Organization Nagasaki university
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
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 12 Month 10 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 Open public recruiting
Date of protocol fixation
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
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 10 Day
Last modified on
2011 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006671

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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