A Survey of Treatment Trends of Diabetic Macular Edema by Miyagi Medical Welfare Information Network

JRCT ID: jRCT1020230002

Registered date:17/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: diabetic macular edema
• Date of first enrollment: 15/03/2023
• Target sample size: 250
• Study type: Observational

Outcome(s)

• Primary Outcome: 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

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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)

Related Information

• Primary Sponsor: Nakazawa Toru
• Secondary Sponsor: Yamabe Masafumi,Novartis Pharma K.K.