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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs061180065

Registered date:19/03/2019

Ehime Macular Edema Study

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedtype 2 diabetes mellitus and macular edema
Date of first enrollment22/05/2019
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Tofogliflozin 20mg/day for 52 weeks

Outcome(s)

Primary OutcomeThe change of CRT at 52 weeks
Secondary OutcomeChanges 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

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 80age old
GenderBoth
Include criteriaPatients 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
Exclude criteriaPatients 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

Related Information

Contact

Public contact
Name Shinya Furukawa
Address 10-13,Dogo-Himata,Matsuyama,Ehime Ehime Japan 790-8577
Telephone +81-89-927-9193
E-mail shinya.furukawa@gmail.com
Affiliation Ehime University
Scientific contact
Name Atsushi Shiraishi
Address Shitsukawa, Toon, Ehime Ehime Japan 791-0295
Telephone +81-89-960-5361
E-mail shiraia@m.ehime-u.ac.jp
Affiliation Ehime University Hospital