Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 56
- 主要终点
- Change From Baseline in Central Retinal Thickness in the Study Eye
研究概览
简要总结
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •18 years of age or older with diabetic macular edema
- •History of vitrectomy
- •Central retinal thickness ≥ 275 µm
- •Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
排除标准
- •Known anticipated need for ocular surgery during the study period
- •History of glaucoma or current high eye pressure requiring more than 1 medication
- •Uncontrolled systemic disease
- •Known allergy to the study medication
- •Known steroid-responder
- •Use of systemic steroids
- •Female subjects that are pregnant, nursing or planning a pregnancy
研究组 & 干预措施
700 µg Dexamethasone Implant
700 µg dexamethasone implant in the study eye at Day 1
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Change From Baseline in Central Retinal Thickness in the Study Eye
时间窗: Baseline, Week 26
Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.
次要结局
- Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye(Baseline, Week 26)
- Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye(Baseline, Week 26)
- Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye(Baseline, Week 26)