NCT02121197已完成不适用
A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)
Association for Innovation and Biomedical Research on Light and Image25 个研究点 分布在 8 个国家目标入组 321 人开始时间: 2014年8月最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 321
- 试验地点
- 25
- 主要终点
- Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.
研究概览
简要总结
To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with diabetes
- •DME in the study eye (if both eyes have DME both eyes will be included in analysis)
- •BCVA minimum of 20/200 (35 letters)
- •Central Macular Thickness (CMT) ≥300 µm
- •Patients with DME who were treated with Ozurdex at least twice (baseline is before the first Ozurdex injection).
- •Follow up of at least 6 months after the last Ozurdex injection given
- •Complete records including BCVA (OCT and Fluorescein Angiography (FA) if available) throughout the follow up
排除标准
- •Patients with ME not secondary to Diabetes Mellitus (DM).
- •Presence of other retinopathies (AMD, RVO) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity)
- •Previous ocular trauma or surgery other than cataract extraction
- •Intravitreal triamcinolone ≤6 months before baseline
- •Intravitreal bevacizumab, ranibizumab, or pegaptanib <1 months before baseline
- •Marked intraocular pressure (IOP) elevation in response to any previous steroid treatment
- •Ocular Hypertension (OHT) in the study eye(s)
- •IOP >23 mm Hg without antiglaucoma medication
- •IOP >21 mm Hg with one antiglaucoma medication
- •Use of 2 or more antiglaucoma medications
- •Glaucoma - Visual Fields (VF) defect > 4 dB
结局指标
主要结局
Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.
时间窗: 6 month
Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (\<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients.
次要结局
未报告次要终点
研究者
研究点 (25)
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