UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010562 |
|---|---|
| Receipt number | R000012351 |
| Scientific Title | Randomized Controlled Trial of the efficacy and safety of Ranibizumab and Aflibercept for polypoidal chroidal vasculopathy |
| Date of disclosure of the study information | 2013/04/23 |
| Last modified on | 2016/10/24 09:22:46 |
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Basic information
Public title
Randomized Controlled Trial of the efficacy and safety of Ranibizumab and Aflibercept for polypoidal chroidal vasculopathy
Acronym
Randomized Controlled Trial of the efficacy of Ranibizumab and Aflibercept for PCV
Scientific Title
Randomized Controlled Trial of the efficacy and safety of Ranibizumab and Aflibercept for polypoidal chroidal vasculopathy
Scientific Title:Acronym
Randomized Controlled Trial of the efficacy of Ranibizumab and Aflibercept for PCV
Region
| Japan |
Condition
Condition
polypoidal chroidal vasculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of intravitreal ranibizumab and aflibercept in patients with PCV
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of best-collected visual acuity at month 6
Key secondary outcomes
Change of polypoidal lesion, retinal edema,subretinal fluid,serous PED, the number of injection of medicine, side effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ranibizumab(Lucentis)
Interventions/Control_2
Aflibercept(Eylea)
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
1)visual acuity: >0.1
2)treatment naive PCV
3)the patient with exdative change or hemorrhage in fovea
Key exclusion criteria
PCV with type 2 CNV.
severe glaucoma,diabetic macular edema,diabetic retinopath.
intraocular surgery(<2 months).
allergy to fluorescein or indocyanine green.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Joko |
Organization
Ehime university faculty of medicine
Division name
Department of Ophthalmology
Zip code
Address
Shitsukawa, Touon-city, Ehime 791-0295, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ehime university faculty of medicine
Division name
Department of Ophthalmology
Zip code
Address
Shitsukawa, Touon-city, Ehime 791-0295, Japan
TEL
089-964-5111
Homepage URL
takeshi@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Ehime university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 04 | Month | 23 | 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
| 2013 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2016 | Year | 10 | Month | 24 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 22 | Day |
Last modified on
| 2016 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012351
