JRCT ID: jRCTs061180065
Registered date:19/03/2019
Ehime Macular Edema Study
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | type 2 diabetes mellitus and macular edema |
Date of first enrollment | 22/05/2019 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Tofogliflozin 20mg/day for 52 weeks |
Outcome(s)
Primary Outcome | The change of CRT at 52 weeks |
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Secondary Outcome | 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 |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | < 80age old |
Gender | Both |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | Shiraishi Atsushi |
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Secondary Sponsor | |
Source(s) of Monetary Support | KOWA Company Ltd |
Secondary ID(s) | UMIN000029609 |
Contact
Public contact | |
Name | Shinya Furukawa |
Address | 10-13,Dogo-Himata,Matsuyama,Ehime Ehime Japan 790-8577 |
Telephone | +81-89-927-9193 |
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 |
shiraia@m.ehime-u.ac.jp | |
Affiliation | Ehime University Hospital |