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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028002
Receipt No. 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

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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
Registered date File name

Research case data
Registered date File name


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