NCT04647214已完成不适用
ARGOS - A Phase IV, Prospective, 18-month Study to Assess the Effectiveness and Safety of Bimatoprost Intracameral Implant (DURYSTA) in US Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 220
- 试验地点
- 39
- 主要终点
- Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care
研究概览
简要总结
Study to collect effectiveness and safety data after administration of a bimatoprost intracameral implant in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient diagnosed with OAG or OHT who is scheduled to receive a bimatoprost intracameral implant in at least one eye.
排除标准
- •A history of any of the following ocular surgeries in the eye due to receive a bimatoprost intracameral implant:Ahmed Glaucoma Valve, Baerveldt shunt, Ex-Press glaucoma shunt implantation, Molteno shunt, Trabeculectomy, Vitrectomy, retinal surgery, CyPass Micro-Stent or Anterior Chamber Intraocular Lens (AC IOL) placement.
- •Concurrent or anticipated enrollment in an interventional clinical trial involving either an investigational medicinal product or medical device.
- •Previous enrollment in another Allergan bimatoprost intracameral implant study.
结局指标
主要结局
Proportion of treated eyes that did not receive additional Intraocular Pressure (IOP) -lowering intervention/therapy per standard medical care
时间窗: Baseline to Month 6
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
次要结局
- Mean reduction in the number of topical IOP-lowering medications(Baseline to Month 18)
- Proportion of treated eyes achieving the predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy(Baseline to Month 12)
- Proportion of treated eyes not receiving additional IOP-lowering intervention/therapy per standard medical care(Baseline to Month 18)
- Time from bimatoprost intracameral implant to first additional IOP-lowering intervention/therapy(Baseline to Month 18)
- Proportion of treated eyes achieving predefined IOP outcomes without receiving additional IOP-lowering intervention/therapy(Baseline to Month 18)
- Proportion of treated eyes achieving complete success(Baseline to Month 18)
- Proportion of treated eyes achieving qualified success(Baseline to Month 18)
- Number of participants experiencing treatment emergent adverse events(Baseline to Month 18)
研究者
研究点 (39)
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