NCT01892163已完成3 期
A Multicentre Prospective Open-label Randomised Clinical Trial Comparing the Efficacy of Fixed Versus PRN Dosing of 700 μg Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) in Patients With Refractory Diabetic Macular Oedema
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months
研究概览
简要总结
Multicentre randomized controlled trial to evaluate whether 5 monthly fixed dosing of 700 µg Dexamethasone Posterior Segment Drug Delivery System (Ozurdex) is as efficacious as Optical coherence tomography (OCT)-guided PRN dosing in patients with refractory diabetic macular edema.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Subjects of either sex aged 18 years or over
- •Diagnosis of diabetes mellitus (type 1 or type 2).
- •Best corrected visual acuity in the study eye between ≥34 and ≤73 ETDRS letters at 1m at baseline attributable to diabetic macular edema (DME)
- •On clinical exam at baseline in the study eye, retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield > 300 microns despite previous therapy.
- •Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.
- •Ability to return for study visits
- •Visual acuity in fellow eye ≥ 2/60
- •Ability to give informed consent throughout the duration of the study
排除标准
- •Macular ischaemia
- •Macular oedema is considered to be due to a cause other than diabetic macular oedema.
- •Co-existent ocular disease
- •An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular oedema or alter visual acuity during the course of the study.
- •A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more.
结局指标
主要结局
The Difference Between Arms in the Change From Baseline in Best Corrected Visual Acuity at 12 Months
时间窗: Baseline and 12 months
次要结局
- Proportion of Patients With Ocular and Systemic Serious Adverse Events(12 months)
- Difference Between Arms in Change From Baseline Composite Scores of the National Eye Institute Visual Function Questionnaire (VFQ-25).(Baseline and 12 months)
- Difference Between Arms in Change in Central Subfield Thickness.(Baseline and 12 months)
研究者
Sobha Sivaprasad
Consultant
Moorfields Eye Hospital NHS Foundation Trust
研究点 (2)
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