UMIN-CTR Clinical Trial

Basic information
Public title	Survey of treatment for diabetic macular edema in Japan
Acronym	STREAT-DME 2 study
Scientific Title	Survey of treatment pattern and prognosis about diabetic macular edema in Japan
Scientific Title:Acronym	STREAT-DME 2 study
Region	Japan

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

Objectives
Narrative objectives1	To conduct a nationwide survey on the treatment pattern and treatment prognosis for two years from the start of intervention for diabetic macular edema in Japan.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dynamic change of visual improvement after 2-years from initial intervention
Key secondary outcomes	Dynamic change of treatment pattern during 2 years of clinical course

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	treatment-naive diabetic macular edema who have medical record during 2 years since initial intervention
Key exclusion criteria	patients who had vitreous retinal disease other than diabetic retinopathy
Target sample size	2000

Research contact person
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	193-8639
Address	1163 Tate-machi, Hachioji, Tokyo
TEL	+81426655611
Email	masahiko@v101.vaio.ne.jp

Public contact
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	193-8639
Address	1163 Tate-machi, Hachioji, Tokyo
TEL	+81426655611
Homepage URL
Email	kelloggmi@yahoo.co.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Institutional Review Board in Tokyo Medical University
Address	6-7-1 Nishi-Shinjuku, Shinjuku, Tokyo
Tel	0333426111
Email	tokyo-med@esct.bvits.com

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	2022 Year 09 Month 20 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	Open public recruiting
Date of protocol fixation	2022 Year 05 Month 01 Day
Date of IRB	2022 Year 06 Month 01 Day
Anticipated trial start date	2022 Year 07 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 12 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 12 Month 31 Day

Other
Other related information	Treatment naive diabetic macular edema Initial intervention received from 2015 to 2019 Each case had medical record more than 2years since initial intervention Visual acuity and central macular thickness recorded at the time of intervention and final date of 2-years.

Management information
Registered date	2022 Year 09 Month 08 Day
Last modified on	2022 Year 09 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055688