UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011703
Receipt number R000012529
Scientific Title Randomized controlled phase IV trial of combination aflibercept and Kallidinogenase for neovascular age-related macular degeneration
Date of disclosure of the study information 2013/09/10
Last modified on 2014/05/24 16:44:48

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Basic information

Public title

Randomized controlled phase IV trial of combination aflibercept and Kallidinogenase for neovascular age-related macular degeneration

Acronym

Combined trial of aflibercept and Kallidinogenase for neovascular age-related macular degeneration

Scientific Title

Randomized controlled phase IV trial of combination aflibercept and Kallidinogenase for neovascular age-related macular degeneration

Scientific Title:Acronym

Combined trial of aflibercept and Kallidinogenase for neovascular 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 evaluate whether Kallidinigenase and aflibercept intravitreal injections would provide added efficacy over aflibercept alone.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

central retinal thickness

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

Kallidinogenase internal use(+) 20cases

Interventions/Control_2

Kallidinigenase internal use(-) 20cases

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

40 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Subjects were eligible if the following criteria were met:
1) Intravitreal injection of aflibercept for neovascular age-related macular degeneration
2) Age>40years
3) Ability to provide written informed consent for this study

Key exclusion criteria

1)internal use of kallidinogenase
2)intravitreal anti-VEGF therapy or intravitreal steroid therapy in the study eye within the past 6 months
3)photodynamic therapy or focal laser in the study eye within the past 6 months
4)surgical therapy in the study eye within the past 6 months
5)past allergic reaction for kallidinigenase
6)pregnancy (positive pregnancy test) women
7)participation in another simultaneous medical investigation or trial within the past 3 months
8)other conditions that the investigator believed would pose a significant hazard to the subject if investigational therapy were initiated

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mineo Kondo

Organization

Mie University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-174 Edobashi Tsu, Mie, Japan

TEL

059-232-1111

Email

ganka@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hisashi Matsubara

Organization

Mie University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-174 Edobashi Tsu, Mie, Japan

TEL

059-232-1111

Homepage URL


Email

ganka@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Graduate School of Medicine
Department of Ophthalmology

Institute

Department

Personal name



Funding Source

Organization

Sanwa Kagaku Kenkyusho Com.,LTD

Organization

Division

Category of Funding Organization

Profit organization

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

2013 Year 09 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

Terminated

Date of protocol fixation

2013 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 09 Month 11 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

2013 Year 09 Month 10 Day

Last modified on

2014 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012529


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name