UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031620

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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