A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 554
- 主要终点
- Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye
研究概览
简要总结
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •18 years of age or older with diabetic macular edema;
- •Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
- •Visual acuity in other eye no worse than 20/200
排除标准
- •Known anticipated need for ocular surgery within next 12 months;
- •History of glaucoma or current high eye pressure requiring more than 1 medication;
- •Uncontrolled systemic disease;
- •Known steroid-responder;
- •Use of systemic steroids;
- •Use of Warfarin/Heparin
研究组 & 干预措施
Dexamethasone 700 μg
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
干预措施: Dexamethasone (Drug)
Dexamethasone 350 μg
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
干预措施: Dexamethasone (Drug)
Sham
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
干预措施: Sham (Other)
结局指标
主要结局
Percentage of Patients With a Best Corrected Visual Acuity (BCVA) Improvement of ≥15 Letters From Baseline in the Study Eye
时间窗: Baseline, Month 39/Final Visit
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
次要结局
- Percentage of Patients With a BCVA Improvement of ≥10 Letters From Baseline in the Study Eye(Baseline, Month 39/Final Visit)
- Change From Baseline in Retinal Thickness as Measured by Optical Coherence Tomography (OCT)(Baseline, Month 39/Final Visit)
- Average Change From Baseline in BCVA in the Study Eye(Baseline, 39 Months)
- Change From Baseline in BCVA in the Study Eye(Baseline, Month 39/Final Visit)