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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038335
Receipt No. R000043640
Scientific Title The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Date of disclosure of the study information 2019/10/21
Last modified on 2020/04/19

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Basic information
Public title The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Acronym The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Scientific Title The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Scientific Title:Acronym The evaluation of treatment effect for age-related macular degeneration by using aflibercept preferentially in Yamaguchi University.
Region
Japan

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

Objectives
Narrative objectives1 In the treatment of anti-vascular endothelial growth factor (VEGF) agents injection for age-related macular degeneration (AMD), patients are needed for prolonged repeated treatment for the recurrence exudation to maintenance of visual acuity, and physical, psychological and economic burden of patients become problem. The recurrence intervals of AMD are differ in individuals, so it is be considered that the retreatment intervals of anti-VEGF agents injection had better to be adjusted to provide the needed performance with minimum injections. So we considered that more individualized retreatment regimen could be these alleviate a burden on patients. In this study, we evaluated retrospectively the treatment effect and interval of intravitreal aflibercept injection preferentially for untreated AMD in Yamaguchi University Hospital.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change of visual acuity at 2nd year after starting treatment
Key secondary outcomes The treatment interval of aflibercept at 2nd year after starting treatment

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Untreated age-related macular degeneration patients started the treatment of aflibercept injection during study period
Key exclusion criteria 1) The patient who had a history of treatment using anti-VEGF agents, 2) The patient who entry to other intervention study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Kimura
Organization Yamaguchi University graduate school of medicine
Division name Department of Ophthalmology
Zip code 755-0032
Address 1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
TEL 0836-22-2278
Email k.kimura@yamaguchi-u.ac.jp

Public contact
Name of contact person
1st name Makiko
Middle name
Last name Wakuta
Organization Yamaguchi University graduate school of medicine
Division name Department of Ophthalmology
Zip code 755-0032
Address 1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
TEL 0836-22-2278
Homepage URL
Email mwakut@yamaguchi-u.ac.jp

Sponsor
Institute Department of Ophthalmology Yamaguchi University graduate school of medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology Yamaguchi University graduate school of medicine
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 Center For Clinical Research, Yamaguchi University Hospital
Address 1-1-1 Minami Kogushi, Ube city, Yamaguchi, Japan
Tel 0836-22-2428
Email me223@yamaguchi-u.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
2019 Year 10 Month 21 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 73
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 No longer recruiting
Date of protocol fixation
2013 Year 08 Month 01 Day
Date of IRB
2017 Year 10 Month 27 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information Retrospective observational study without intervention. Treatment naive exdative age-related macular degeneration patients using aflibercept injetion from 1st/Aug./2013 to 31th/Jul./2017 in Yamaguchi University Hospital.
extracted items; gender, birth year/month, diagnosis, the date of first treatment, used drug, adverse events, treatment history, current medical history, examination findings of the eye, visual acuity, intraocular pressure, the findings of fluorescein and indocyanine green angiography, optical coherence tomography, color fundus photograph

Management information
Registered date
2019 Year 10 Month 18 Day
Last modified on
2020 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043640

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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