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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025093
Receipt No. R000028854
Scientific Title Clinical practice pattern of anti-vascular endothelial growth factor treatment in management of diabetic macular edema
Date of disclosure of the study information 2016/11/30
Last modified on 2018/08/15

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Basic information
Public title Clinical practice pattern of anti-vascular endothelial growth factor treatment in management of diabetic macular edema
Acronym Clinical practice pattern of anti-VEGF treatment.
Scientific Title Clinical practice pattern of anti-vascular endothelial growth factor treatment in management of diabetic macular edema
Scientific Title:Acronym Clinical practice pattern of anti-VEGF treatment.
Region
Japan

Condition
Condition Diabetic macular edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate what kind of treatment schedules performed against diabetic retinopathy (DME) using the anti-vascular endothelial growth factor (VEGF) agents and clarify its tendency.
Basic objectives2 Others
Basic objectives -Others To investigate treatment trends
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire result analysis
Key secondary outcomes

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 Five-hundred of domestic facilities that are treating DME with vision threatening.
Key exclusion criteria Facilities that do not agree with this research due to some reason.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Sugimoto
Organization Mie University Graduate School of Medicine.
Division name Department of Ophthalmology.
Zip code
Address 2-174, Edobashi, Tsu, Mie, Japan, 514-8507.
TEL 059-232-1111
Email sugmochi@aqua.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Sugimoto
Organization Mie University Graduate School of Medicine.
Division name Department of Ophthalmology.
Zip code
Address 2-174, Edobashi, Tsu, Mie, Japan, 514-8507.
TEL 059-232-1111
Homepage URL
Email sugmochi@aqua.ocn.ne.jp

Sponsor
Institute Department of Ophthalmology, Mie University Graduate School of Medicine.
Institute
Department

Funding Source
Organization Department of Ophthalmology, Mie University Graduate School of Medicine.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 11 Month 30 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 Completed
Date of protocol fixation
2016 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Send questionnaires to each facility and totalize the results. Questionnaires are managed by personal information administrators randomly appending anonymization number for each facility, after sending it by management based on the consolidation number table. Also, it will be returned to the personal information manager. In this process, the respondents of the questionnaire can not grasp the questionnaire other than the personal information manager, and anonymization is done.
The results will be reported in the form of academic societies and papers.

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2018 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028854

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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