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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name