UMIN-CTR Clinical Trial

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

Diabetic Macular Edema

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name	Masahiko
Middle name
Last name	Shimura

Organization

Tokyo Medical University Hachioji Medical Center

Division name

Department of Ophthalmology

Zip code

1930998

Address

1163 Tate-machi, Hachioji, Tokyo

TEL

0426655611

Email

masahiko@v101.vaio.ne.jp

Name of contact person

1st name	Masahiko
Middle name
Last name	Shimura

Organization

Tokyo Medical University Hachioji Medical Center

Division name

Department of Ophthalmology

Zip code

1930998

Address

1163 Tate-machi, Hachioji, Tokyo

TEL

0426655611

Homepage URL

Email

masahiko@v101.vaio.ne.jp

Institute

J-CRERST organization

Institute

Department

Personal name

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board in Tokyo Medical University Hachioji Medical Center

Address

1163 Tate-machi, Hachioji, Tokyo

Tel

0426655611

Email

masahiko@v101.vaio.ne.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）、

Date of disclosure of the study information

2016

Year

07

Month

15

Day

URL releasing protocol

https://www.ncbi.nlm.nih.gov/pubmed/31784500

Publication of results

Unpublished

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/31784500

Number of participants that the trial has enrolled

1552

Results

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

2020

Year

01

Month

15

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

2049 treatment naive eyes of 1552 patients with center involving diabetric macular edema were eligible for this study.

Participant flow

all data were extracted from clinical record in each eye.

Adverse events

No serious advrse events were reported.

Outcome measures

treatment patterns and its frequencies in each eligible eyes were investigated. Two-year morphological and functional visual prognosis were also monitoired.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

07

Month

15

Day

Date of IRB

2016

Year

06

Month

16

Day

Anticipated trial start date

2016

Year

07

Month

15

Day

Last follow-up date

2017

Year

12

Month

31

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 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

Registered date

2016

Year

07

Month

13

Day

Last modified on

2020

Year

01

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026698

Single case data URL

Value
https://center6.umin.ac.jp/ice/26698