NCT04136366已完成3 期
The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 Versus Standard-of-Care for Prevention of Proliferative Vitreoretinopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 23
- 主要终点
- Recurrent Retinal Detachment Compared to Historical Rates
研究概览
简要总结
The GUARD Trial is a multi-center, randomized, controlled, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Subject is 18 years or older of any gender or race
- •Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretinopathy or open globe injury
- •Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits
- •Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial
排除标准
- •History of severe non-proliferative or proliferative diabetic retinopathy
- •Other planned eye surgery during the course of the trial
- •Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment
研究组 & 干预措施
ADX-2191 (intravitreal methotrexate 0.8%)
Experimental
ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.
干预措施: ADX-2191 (intravitreal methotrexate 0.8%) (Drug)
Standard surgical care procedure
Active Comparator
Standard procedure performed.
干预措施: Standard surgical care procedure (Other)
结局指标
主要结局
Recurrent Retinal Detachment Compared to Historical Rates
时间窗: Efficacy assessment period (Week 1 to Week 24)
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
次要结局
- Number of Subjects With Recurrent Retinal Detachment(Efficacy assessment period (Week 1 to Week 24))
- Best-corrected Visual Acuity(Efficacy assessment period (Week 1 to Week 24))
- Macular Epiretinal Membrane(Week 24)
- Intraocular Pressure Less Than 5 mmHg for Study Eye(Week 24)
- Central Macular Subfield Thickness(Week 24)
研究者
研究点 (23)
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