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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Neovascular age-related macular degeneration | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Key exclusion criteria | Prior vitrectomy
Rupture of posterior lens capsule Cataract surgery within 3 months Angioid Streaks Myopic chodoidal neovascularization Vitelliform macular dystrophy |
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Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
tujikawa@kuhp.kyoto-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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IRB Contact (For public release) | |
Organization | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Management information | |||||||
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Last modified on |
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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 |