Unique ID issued by UMIN | UMIN000028002 |
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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 |
Achievement of Precision Medicine for AMD by Treatment Regimen Comparison and Genetic Analysis
PREARRANGE study
Achievement of Precision Medicine for AMD by Treatment Regimen Comparison and Genetic Analysis
PREARRANGE study
Japan |
Neovascular age-related macular degeneration
Ophthalmology |
Others
YES
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.
Others
Genome-wide association analysis will be conducted to discover genes associated with treatment outcome for precision medicine of age-realted macular degeneration.
Visual acuity change at 12th month
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
Interventional
Parallel
Non-randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Aflibercept 2mg (PRN regimen), 24 months period
Aflibercept 2mg (TAE regimen), 24 months period
50 | years-old | <= |
100 | years-old | > |
Male and Female
Treatment-naive neovasucular age-related macular degeneration
Best corrected visual acuity of 0.05-0.8
Eyes without subfoveal fibrosis
Prior vitrectomy
Rupture of posterior lens capsule
Cataract surgery within 3 months
Angioid Streaks
Myopic chodoidal neovascularization
Vitelliform macular dystrophy
500
1st name | |
Middle name | |
Last name | Akitaka Tsujikawa |
Kyoto University Graduate School of Medicine
Ophthalmology and Visual Sciences
54 Kawahara, Shogoin, Sakyo, Kyoto 606-8507, Japan
+81-75-751-3248
tujikawa@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Kenji Yamashiro |
Kyoto University Graduate School of Medicine
Ophthalmology and Visual Sciences
54 Kawahara, Shogoin, Sakyo, Kyoto 606-8507, Japan
+81-75-751-3248
yamashro@kuhp.kyoto-u.ac.jp
Department of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine
Bayer Holding Ltd.
Profit organization
NO
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)
2017 | Year | 07 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 06 | Month | 01 | Day |
2017 | Year | 07 | Month | 01 | Day |
2017 | Year | 06 | Month | 29 | Day |
2017 | Year | 07 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031620
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