NL-OMON39983已完成不适用
The Most Effective Treatment Strategy for Diabetic Macular Edema. - METS for DME
Oogziekenhuis Rotterdam0 个研究点目标入组 456 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 456
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Age * 18 years.
- •Able to read and sign the written informed consent.
- •Diagnosis of DME, based on ETDRS criteria and confirmed by macular edema on optical coherence tomography (OCT, Heidelberg Spectralis), defined as CFT * 340 micron.
- •VA loss due to DME, with VA being between 45 and 85 letters as measured on ETDRS chart.
- •If both eyes are eligible, the eye with the highest CFT will be selected as the study eye.
排除标准
- •Previous laser photocoagulation therapy within the last 6 months.
- •Previous anti-VEGF therapy (Avastin, Lucentis, Eylea, or any investigational anti-VEGF drug) within the last 3 months.
- •Previous subtenon*s or intravitreal triamcinolone injection within the last 6 months.
- •Steroid implants of any kind within the last 3 years.
- •Macular ischemia confirmed by fluorescein angiography.
- •Vitreoretinal traction or epiretinal membranes with the potential of macular structural damage and function loss, confirmed by OCT.
- •Other eye conditions affecting VA prognosis, including pre-existent (deep) amblyopia.
- •Any ocular surgery/intervention within last three months before enrollment.
- •Any ocular surgery/intervention anticipated during the course of the study.
- •Ocular opacities hampering adequate imaging of the posterior pole.
- •Poor control of DM with glycated hemoglobin (HbA1c) of * 86% in last 6 months.
- •Allergy to fluorescein or anti-VEGF, or any of its preservatives.
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