Ehime Macular Edema Study

Recruiting

• Conditions: type 2 diabetes mellitus and macular edema

• Registration Number: jRCTs061180065

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-19
• Study Start: 2019-05-22
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
-		The change of CRT at 52 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in CRT	4, 12, 24 weeks	Changes in CRT (after 4, 12, 24 weeks)
Changes in corrective eyesight		Changes in corrective eyesight
Changes in retinal thickness of the macular region		Changes in retinal thickness of the macular region
Changes in mean macular volume		Changes in mean macular volume
Number of times of use of anti-VEGF drug		Number of times of use of anti-VEGF drug (EYLEA, LUCENTIS)
Rescue treatment		Rescue treatment; Compared to baseline; When the CRT deteriorates by 100 micro m or more
Changes in severity of diabetic retinopathy		Changes in severity of diabetic retinopathy
Changes in HbA1c, FBG		Changes in HbA1c, FBG
Changes in TG, HDL-C, LDL-C, Cholesterol Extraction Ability		Changes in TG, HDL-C, LDL-C, Cholesterol Extraction Ability
Changes in Body weight, waist circumference, SBP, DBP, ECG		Changes in Body weight, waist circumference, SBP, DBP, ECG
Amount of change in urination frequency and nighttime urination frequency		Amount of change in urination frequency and nighttime urination frequency
Factors influencing the amount of change in CRT		Factors influencing the amount of change in CRT