Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients 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
- 363
- 主要终点
- Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
研究概览
简要总结
This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).
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
- •Diagnosis of type 1 or 2 diabetes mellitus
- •Diagnosis of macular edema
- •Visual acuity between 20/200 to 20/40
排除标准
- •Eye surgery to the study eye within 3 months
- •Use of Ozurdex® within 9 months
- •Any active ocular inflammation and infection
- •Diagnosis of glaucoma
- •Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months
研究组 & 干预措施
dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
干预措施: dexamethasone Intravitreal Implant (Drug)
ranibizumab
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
时间窗: Baseline, 12 Months
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). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
次要结局
- Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye(Baseline, Month 12)
- Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)(Baseline, Month 12)