jRCT1020230002招募中不适用
A Survey of Treatment Trends of Diabetic Macular Edema by Miyagi Medical Welfare Information Network (MMWIN study in DME patients)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 主要终点
- The proportion of patients with newly diagnosed DME treated with each treatment pattern
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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)
结局指标
主要结局
The proportion of patients with newly diagnosed DME treated with each treatment pattern
时间窗: 12 months
Treatment patterns include: - Anti-VEGF monotherapy - Anti-VEGF combination therapy - Non-anti-VEGF therapy (Laser (grid/direct, panretinal photocoagulation)/Vitreous surgery/Steroids) - No treatment
次要结局
- Mean change in BCVA(12 months)
- Mean change in CSFT(12 months)
- Average number of visits(12 months)
- Mean number of anti-VEGF injections and treatment interval(12 months)
- Time to first anti-VEGF drug injection
- Dropout rate(12 months)
- Mean change in blood pressure(12 months)
- Mean HbA1c(12 months)
- Mean estimated glomerular filtration rate (eGFR)(12 months)
- Mean lipids(12 months)
- Number of APTC cardiovascular events(12 months)
研究者
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