UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006869 |
|---|---|
| Receipt number | 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 23:00:36 |
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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
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
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006671
