UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029148
Receipt No. 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 2018/03/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email aiyoneda@nagasaki-med.jrc.or.jp

Sponsor
Institute The Japanese Red Cross Nagasaki Genbaku Hospital
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2017 Year 08 Month 14 Day
Date of IRB
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
2018 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033238

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.