UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029148 |
|---|---|
| Receipt number | R000033238 |
| Scientific Title | Comparison between photodynamic therapy with ranibizumab and fixed dosing aflibercept for polypoidal choroidal vasculopathy |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2019/09/18 17:58:55 |
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Basic information
Public title
Comparison between photodynamic therapy with ranibizumab and fixed dosing aflibercept for polypoidal choroidal vasculopathy
Acronym
Comparison between photodynamic therapy with ranibizumab and fixed dosing aflibercept for polypoidal choroidal vasculopathy
Scientific Title
Comparison between photodynamic therapy with ranibizumab and fixed dosing aflibercept for polypoidal choroidal vasculopathy
Scientific Title:Acronym
Comparison between photodynamic therapy with ranibizumab and fixed dosing aflibercept for polypoidal choroidal vasculopathy
Region
| Japan |
Condition
Condition
Polypoidal choroidal vasculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the results of photodynamic therapy with ranibizumab and fixed dosing aflibercept for treatment-naive polypoidal choroidal vasculopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of best-corrected visual acuity 3, 12 and 24 months after treatment
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
1)Patients who were diagnosed with polypoidal choroidal vasculopathy(PCV) and were initially treated between November 2009 and November 2013
2)Minimum follow-up period of 2 years.
Key exclusion criteria
1)Concurrent ocular diseases affecting
visual acuity
2)Previous treatment for PCV
3)History of intraocular surgery other than phacoemulsification
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ai Yoneda |
Organization
The Japanese Red Cross Nagasaki Genbaku Hospital
Division name
Department of Ophthalmology
Zip code
Address
3-15 Mori-machi, Nagasaki, Nagasaki, Japan
TEL
095-847-1511
aiyoneda@nagasaki-med.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Yoneda |
Organization
The Japanese Red Cross Nagasaki Genbaku Hospital
Division name
Department of Ophthalmology
Zip code
Address
3-15 Mori-machi, Nagasaki, Nagasaki, Japan
TEL
095-847-1511
Homepage URL
aiyoneda@nagasaki-med.jrc.or.jp
Sponsor or person
Institute
The Japanese Red Cross Nagasaki Genbaku Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2017 | Year | 09 | Month | 15 | 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
| 2017 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study
Management information
Registered date
| 2017 | Year | 09 | Month | 14 | Day |
Last modified on
| 2019 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033238
