UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028002
Receipt number R000031620
Scientific Title Achievement of Precision Medicine for AMD by Treatment Regimen Comparison and Genetic Analysis
Date of disclosure of the study information 2017/07/01
Last modified on 2017/07/05 16:56:39

* 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

Achievement of Precision Medicine for AMD by Treatment Regimen Comparison and Genetic Analysis

Acronym

PREARRANGE study

Scientific Title

Achievement of Precision Medicine for AMD by Treatment Regimen Comparison and Genetic Analysis

Scientific Title:Acronym

PREARRANGE study

Region

Japan


Condition

Condition

Neovascular age-related macular degeneration

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

In prospective multi center study of anti-VEGF treatment for age-related macular degeneration, aflibercept treatment with pro re nat a (PRN) regimen and with treat and extend (TAE) regimen for 2 years will be compared.

Basic objectives2

Others

Basic objectives -Others

Genome-wide association analysis will be conducted to discover genes associated with treatment outcome for precision medicine of age-realted macular degeneration.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Visual acuity change at 12th month

Key secondary outcomes

Visual acuity change at 24th month
Visual acuity at 12th month
Visual acuity at 24th month
Number of injections during 12 months
Number of injections during 24 months
Genes associted with visual acuity, visual acuity change, and number of injections
Genes associted with outcome of loading treatment, appropriate interval of injection for each patient


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-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

Aflibercept 2mg (PRN regimen), 24 months period

Interventions/Control_2

Aflibercept 2mg (TAE regimen), 24 months period

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

100 years-old >

Gender

Male and Female

Key inclusion criteria

Treatment-naive neovasucular age-related macular degeneration
Best corrected visual acuity of 0.05-0.8
Eyes without subfoveal fibrosis

Key exclusion criteria

Prior vitrectomy
Rupture of posterior lens capsule
Cataract surgery within 3 months
Angioid Streaks
Myopic chodoidal neovascularization
Vitelliform macular dystrophy

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akitaka Tsujikawa

Organization

Kyoto University Graduate School of Medicine

Division name

Ophthalmology and Visual Sciences

Zip code


Address

54 Kawahara, Shogoin, Sakyo, Kyoto 606-8507, Japan

TEL

+81-75-751-3248

Email

tujikawa@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Yamashiro

Organization

Kyoto University Graduate School of Medicine

Division name

Ophthalmology and Visual Sciences

Zip code


Address

54 Kawahara, Shogoin, Sakyo, Kyoto 606-8507, Japan

TEL

+81-75-751-3248

Homepage URL


Email

yamashro@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Bayer Holding 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

秋田大学医学部附属病院(秋田)、自治医科大学附属病院(栃木)、国際医療福祉大学病院(栃木)、東京大学医学部附属病院(東京)、東京女子医科大学病院(東京)、駿河台日本大学病院(東京)、慶応義塾大学病院(東京)、東邦大学医療センター大森病院(東京)、杏林大学医学部付属病院(東京)、聖マリアンナ医科大学病院(神奈川)、群馬大学医学部附属病院(群馬)、高崎佐藤眼科(群馬)、山梨大学医学部附属病院(山梨)、聖隷浜松病院(静岡)、名古屋大学医学部附属病院(愛知)、名古屋市立大学病院(愛知)、三重大学病院、(三重)、大津赤十字病院(滋賀)、京都大学医学部附属病院(京都)、関西医科大学附属病院(大阪)、大阪大学医学部附属病院(大阪)、兵庫医科大学病院(兵庫)、神戸大学医学部附属病院(兵庫)、香川大学医学部附属病院(香川)、島根大学医学部附属病院(島根)


Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 01 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

Enrolling by invitation

Date of protocol fixation

2017 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 01 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

2017 Year 06 Month 29 Day

Last modified on

2017 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031620


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name