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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029497
Receipt No. R000033699
Scientific Title Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Date of disclosure of the study information 2017/10/10
Last modified on 2019/05/17

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Basic information
Public title Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Acronym Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Scientific Title Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Scientific Title:Acronym Transition of visual acuity before initial treatment with neovascular age-related macular degeneration over the past years (A multicenter retrospective study)
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to clarify the difference of the therapeutic effect in the visual acuity before the initial treatment of the photodynamic therapy (PDT), or the anti-vascular endothelial growth factor (VEGF) therapy or PDT with anti-VEGF therapy by using many cases for neovascular age-related macular degeneration over the past years.
Basic objectives2 Others
Basic objectives -Others Transition of visual acuity before initial treatment and treatment methods
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Visual acuity before initial treatment
Key secondary outcomes Type of initial treatment
Visual acuity one year and 2 years after the initial treatment
Central subfield retinal thickness before initial treatment, one year and 2 years after the initial 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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients of age-related macular degeneration with choroidal neovascularization who received photodynamic therapy, intravitreal injections of ranibizumab, aflibercept, pegaptanib, bevacizumab or topical administration of the steroid in the past 10 years (January 1, 2006 to December 31, 2015) and were able to follow more than one year.
Key exclusion criteria Patients have received photodynamic therapy or intravitreal injections of ranibizumab, aflibercept, pegaptanib, or bevacizumab before receiving the initial treatment at each hospital, or patients who refused to participate this study, or patients who are judged to be unfit as the participants of this study.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Masahito
Middle name
Last name Ohji
Organization Shiga University of Medical Science
Division name Department of Ophthalmology
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL 077-548-2276
Email ohji@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name Tomoko
Middle name
Last name Sawada
Organization Shiga University of Medical Science
Division name Department of Ophthalmology
Zip code 520-2192
Address Seta Tsukinowa-cho, Otsu, Shiga, JAPAN
TEL 077-548-2276
Homepage URL
Email tsawada@belle.shiga-med.ac.jp

Sponsor
Institute Department of Ophthalmology, Shiga University of Medical Science
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Research Ethics Committe of Shiga Univercity of Medical Science
Address Seta Tsukinowacho, Otsu, Shiga, JAPAN
Tel 0775483576
Email hqrec@belle.shiga-med.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 滋賀医科大学眼科学講座 Department of Ophthalmology, Shiga University of Medical Science

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 10 Day

Related information
URL releasing protocol http://www.shiga-med.ac.jp/hospital/doc/ethics/files/1633.pdf
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 3099
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
2017 Year 08 Month 30 Day
Date of IRB
2017 Year 08 Month 30 Day
Anticipated trial start date
2017 Year 10 Month 10 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
2020 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information The participants began their initial treatment for neovascular age-related macular degeneration at each research facility in the past decade (January 1, 2006 to December 31, 2015) and were able to follow the passage of more than one year.

Management information
Registered date
2017 Year 10 Month 10 Day
Last modified on
2019 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033699

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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