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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023160
Receipt No. R000026698
Scientific Title Survey of TREATments for Diabetic Macular Edema (STREAT-DME) Study
Date of disclosure of the study information 2016/07/15
Last modified on 2019/01/14

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Basic information
Public title Survey of TREATments for Diabetic Macular Edema (STREAT-DME) Study
Acronym STREAT-DME Study
Scientific Title Survey of TREATments for Diabetic Macular Edema (STREAT-DME) Study
Scientific Title:Acronym STREAT-DME Study
Region
Japan

Condition
Condition Diabetic Macular Edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To survey treatment patterns for diabetic macular edema in our "Real world" clinical situation.
Basic objectives2 Others
Basic objectives -Others To evaluate visual prognosis of diabetic macular edema after "real-world" treatment and compare with previous results from large scale study with anti-VEGF therapy
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of visual acuity and morphological resolution of edema within 2 years of clinical course since initial intervention
Key secondary outcomes % of each intervention and averaged number of each intervention

Base
Study type Others,meta-analysis etc

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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Treatment naive diabatic macular edema which begun any treatment and observed for more than 2 years
Key exclusion criteria Ocular disease other than diabetic macular edema
diabetic macular edema associated with severe systemic disorders
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Shimura
Organization Tokyo Medical University Hachioji Medical Center
Division name Department of Ophthalmology
Zip code
Address 1163 Tate-machi, Hachioji, Tokyo
TEL 0426655611
Email masahiko@v101.vaio.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Shimura
Organization Tokyo Medical University Hachioji Medical Center
Division name Department of Ophthalmology
Zip code
Address 1163 Tate-machi, Hachioji, Tokyo
TEL 0426655611
Homepage URL
Email masahiko@v101.vaio.ne.jp

Sponsor
Institute J-CRERST organization
Institute
Department

Funding Source
Organization self funding
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
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 鹿児島大学病院(鹿児島県)、今村病院(鹿児島県)、東京女子医科大学糖尿病センター(東京都)、東京医科大学病院(東京都)、東京医科大学茨城医療センター(茨城県)、福井大学病院(福井県)、長崎大学病院(長崎県)、和歌山県立医科大学病院(和歌山県)、聖マリアンナ医科大学病院(神奈川県)、岡山大学病院(岡山県)、杏林大学病院(東京都)、信州大学病院(長野県)、兵庫医科大学病院(兵庫県)、徳島大学病院(徳島県)、筑波大学病院(茨城県)、山口大学病院(山口県)、三重大学病院(三重県)、大津赤十字病院(滋賀県)、弘前大学病院(青森県)、引地眼科(北海道)、公立昭和病院(東京都)、防衛医科大学病院(埼玉県)、聖路加病院(東京都)、奈良県立医科大学病院(奈良県)、神戸大学病院(兵庫県)、

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 15 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
Two years visual outcome of treatment naive DME after real-world intervention was depend upon treatment options.
DME with anti-VEGF monotherapy or without anti-VEGF during the clinical course showed better results, in contrast DME with combination therapy showed worse.
From this real-world data, the greater improvement of VA was obtained in a 2-year treatment course of DME dependent on the more recent starting year of intervention. Also, the proportion of eyes treated with anti-VEGF drug increased over time, which may be related to the better prognosis of VA after intervention. 
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 07 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 15 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 07 Month 31 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information Outcome measures are the numbers of each treatment as follows
anti-VEGF therapy (Bevacizumab, Ranibizumab, Aflibercept), corticosteroid (intravitreal triamcinolone, subtenon infusion of triamcinolone), retinal photocoagulation (focal, grid, panretinal), vitrectomy, Lensectomy

Management information
Registered date
2016 Year 07 Month 13 Day
Last modified on
2019 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026698

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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