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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023676
Receipt No. R000027268
Scientific Title Intravitreal anti-VEGF therapies for macular edema folowing age-related macular degeneration
Date of disclosure of the study information 2016/09/01
Last modified on 2019/09/20

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Basic information
Public title Intravitreal anti-VEGF therapies for macular edema folowing age-related macular degeneration
Acronym Intravitreal anti-VEGF therapy for AMD
Scientific Title Intravitreal anti-VEGF therapies for macular edema folowing age-related macular degeneration
Scientific Title:Acronym Intravitreal anti-VEGF therapy for AMD
Region
Japan

Condition
Condition age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine outcomes of patients with anti-vasucular endthelial factor antibody-treated age-related macular degeneration.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity
Key secondary outcomes intraocular pressure, central retinal thickness and choroidal neovascularization using OCT, recurrence of macular edema, smoking history

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria patinets with age-related macular degeneration
Key exclusion criteria none
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Kamao
Organization Kawasaki Medical School
Division name Department of Ophthalmology
Zip code 701-0114
Address Kurashiki
TEL 086-462-1111
Email hironeri@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Kamao
Organization Kawasaki Medical School
Division name Department of Ophthalmology
Zip code 701-0114
Address Kurashiki
TEL 086-462-1111
Homepage URL https://m.kawasaki-m.ac.jp/kenkyu/rinri/kadai/kadai40.php
Email hironeri@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kawasaki Medical School
Address Kurashiki Matsushima 577
Tel 086-462-1111
Email hironeri@med.kawasaki-m.ac.jp

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

Other administrative information
Date of disclosure of the study information
2016 Year 09 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 16 Day
Date of IRB
2016 Year 11 Month 14 Day
Anticipated trial start date
2016 Year 11 Month 14 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study, non-intervention, non-invasive

Management information
Registered date
2016 Year 08 Month 18 Day
Last modified on
2019 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027268

Research Plan
Registered date File name
2017/07/05 研究実施計画書.doc

Research case data specifications
Registered date File name
2017/07/05 AMD 症例データ仕様書.xlsx

Research case data
Registered date File name
2017/07/05 AMD 症例データ.xlsx


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