臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 19, 2019
Last modified on	June. 06, 2025
Trial ID	jRCTs061180065

Scientific Title	The investigation of the effectiveness by tofogliflozin on macular edema among the Japanese patients with type 2 diabetes mellitus (Ehime Macular Edema Study)
Public Title	Ehime Macular Edema Study

Contact for Scientific Queries	Name	Shiraishi Atsushi
	Affiliation	Ehime University Hospital
	Address	Shitsukawa, Toon, Ehime
	Telephone	+81-89-960-5361
	E-mail	shiraia@m.ehime-u.ac.jp
Contact for Public Queries	Name	Furukawa Shinya
	Affiliation	Ehime University
	Address	10-13,Dogo-Himata,Matsuyama,Ehime
	Telephone	+81-89-927-9193
	E-mail	shinya.furukawa@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 01, 2017
Actual date of first enrollment		May. 22, 2019
Target sample size		30
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with diabetic macular edema Patients with a CRT of 250 micro m or more in OCT Patients with corrective eyesight of 0.1 or more Patients with diabetic retinopathy (simple, pre proliferative) Patients who have not undergone other treatments for macular edema (anti-VEGF drug, steroid local injection, retinal photocoagulation, intraocular surgery) within 3 months until acquisition
	Exclusion Criteria	Patients with diabetic macular edema who need and wish anti-VEGF medication Patients with diabetic macular edema who need and wish subtenon Tenon's administration of MaQaid OPHTALMIC INJECTION 20 mg (triamcinolone acetonide) medication Patients with diabetic retinopathy who need Panretinal photocoagulation Patients with obvious vitreous traction at OCT
	Age Minimum	20age old over
	Age Maximum	80age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		type 2 diabetes mellitus and macular edema
Intervention(s)		Tofogliflozin 20mg/day for 52 weeks
Health Condition(s) Keyword		Type 2 diabetes mellitus, Diabetic macular edema
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		The change of CRT at 52 weeks
Secondary Outcome(s)		Changes in CRT (after 4, 12, 24 weeks) Changes in corrective eyesight Changes in retinal thickness of the macular region Changes in mean macular volume Number of times of use of anti-VEGF drug (EYLEA, LUCENTIS) Rescue treatment Compared to baseline When the CRT deteriorates by 100 micro m or more Changes in severity of diabetic retinopathy Changes in HbA1c, FBG Changes in TG, HDL-C, LDL-C, Cholesterol Extraction Ability Changes in Body weight, waist circumference, SBP, DBP, ECG Amount of change in urination frequency and nighttime urination frequency Factors influencing the amount of change in CRT

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	KOWA Company Ltd
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Review Board,Ehime University
Address	454 Shitsukawa, Toon, Ehime
Telephone	+81-89-960-5172
E-Mail	rinri@m.ehime-u.ac.jp
Approval Status	Approval
Date of approval	Mar. 12, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)	UMIN000029609
Issuing Authority	UMIN

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
12	June. 06, 2025	(this page)	Changes
11	May. 22, 2025	Detail	Changes
10	Sept. 02, 2024	Detail	Changes
9	June. 03, 2024	Detail	Changes
8	Mar. 08, 2024	Detail	Changes
7	Nov. 11, 2021	Detail	Changes
6	Oct. 13, 2021	Detail	Changes
5	Feb. 04, 2021	Detail	Changes
4	Sept. 04, 2020	Detail	Changes
3	Jan. 14, 2020	Detail	Changes
2	July. 30, 2019	Detail	Changes
1	Mar. 19, 2019	Detail

List of change history