臨床研究等提出・公開システム

Date of registration	April. 17, 2023
Last modified on	April. 17, 2023
Trial ID	jRCT1020230002

Scientific Title	A Survey of Treatment Trends of Diabetic Macular Edema by Miyagi Medical Welfare Information Network (MMWIN study in DME patients)
Public Title	A Survey of Treatment Trends of Diabetic Macular Edema by Miyagi Medical Welfare Information Network (MMWIN study in DME patients)

Contact for Scientific Queries	Name	Nakazawa Toru
	Affiliation	Department of Ophthalmology, Tohoku University School of Medicine
	Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
	Telephone	+81-22-717-7294
	E-mail	ntoru@oph.med.tohoku.ac.jp
Contact for Public Queries	Name	Nitta Fumihiko
	Affiliation	Department of Ophthalmology, Tohoku University School of Medicine
	Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
	Telephone	+81-22-717-7294
	E-mail	mmwin.dme2023@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 15, 2023
Target sample size		250
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	The research participants are a group of patients aged 18 years or older with center involved DME with central subfield thickness (CSFT) of at least 300 micro m or more in the study eye. The research participants are living in the northeastern part of Japan and who complete enrollment from January 2023 to May 2024. Patients eligible for inclusion in this study have to meet all of the following criteria: (1)Adults (18 years or older) with newly diagnosed DME (treatment naive) (2)Patients expected to regularly visit the hospital for treatment for a year (3)Patients who registered in MMWIN database or who have already registered in MMWIN database at the enrolement of this study (4)Voluntary written consent
	Exclusion Criteria	Patients who do not meet any of the following criteria: Patients with concurrent eye disease that may cause macular edema (Including choroidal neovascularization, retinal vein occlusion, uveitis, and recent intraocular surgery of any cause)
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		diabetic macular edema
Health Condition(s) Keyword		DME, diabetic macular edema
Health Condition(s) Code		D008269
Primary Outcome(s)		Primary endpoint: The proportion of patients with newly diagnosed DME treated with each treatment pattern (Anti-VEGF monotherapy/anti-VEGF combination therapy/non-anti-VEGF therapy (Laser (grid/direct, panretinal photocoagulation)/Vitreous surgery/Steroids)/no treatment) over 12 months
Secondary Outcome(s)		Secondary Endpoints Ophthalmologic Variables (1) Mean change in BCVA at initial diagnosis and 12 months (2) Mean change in CSFT at initial diagnosis and 12 months (3) Average number of visits from initial diagnosis up to 12 months (4) Mean number of anti-VEGF injections and treatment interval (weeks) 12 months after initial diagnosis (5) Time from the initial diagnosis to the start of the first anti-VEGF drug injection (days, average) (6) Dropout rate at 12 months after initial diagnosis Medical Variables (7) Mean change in blood pressure at initial diagnosis and 12 months later (8) Mean HbA1c at initial diagnosis and 12 months (9) Mean estimated glomerular filtration rate (eGFR) at initial diagnosis and 12 months later (10) Mean lipids (serum total cholesterol level etc.) at initial diagnosis and 12 months later (11) Number of APTC (Non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, haemorrhagic death, and death from unknown cause) cardiovascular events that occurred from the initial diagnosis to 12 months by treatment pattern Note: The descriptive statistics of each parameters every outpatient visits and case-plot are also conducted. Exploratory Endpoints (Subgroup Analysis)

Primary Sponsor	Tohoku University School of Medicine

Source of Monetary Support / Secondary Sponsor	Novartis Pharma K.K.
Secondary Sponsor	Applicable

Name of Certified Review Board	Ethics Commitee Tohoku University Graduate School of Medicine
Address	2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan, Miyagi
Telephone	+81-22-717-8007
E-Mail	med-kenkyo@grp.tohoku.ac.jp
Approval Status	Approval
Date of approval	Dec. 20, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none