A Clinical Safety and Efficacy Comparison of NEVANAC 0.1% to Vehicle Following Cataract Surgery in Diabetic Retinopathy Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 263
- 主要终点
- Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
研究概览
简要总结
The purpose of this study is to determine whether nepafenac is safe and effective for reducing the incidence of macular edema following cataract surgery in diabetic retinopathy patients.
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
- Double (Participant, Investigator)
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
- •Patients with non-proliferative diabetic retinopathy (mild, moderate or severe) and planned cataract extraction by phacoemulsification.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Central subfiled macular thickness greater than or equal to 250 microns
- •CME in either eye.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
NEVANAC
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
干预措施: Nepafenac ophthalmic suspension, 0.1% (NEVANAC) (Drug)
NEVANAC
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
干预措施: Prednisolone acetate ophthalmic suspension (OMNIPRED) (Drug)
Nepafenac Vehicle
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
干预措施: Nepafenac ophthalmic suspension vehicle (Other)
Nepafenac Vehicle
One drop three times a day starting on the day prior to cataract surgery (Day -1) and continuing on the day of surgery (Day 0) and for 90 days thereafter.
干预措施: Prednisolone acetate ophthalmic suspension (OMNIPRED) (Drug)
结局指标
主要结局
Percent of Patients Who Developed Macular Edema (ME) Within 90 Days Following Cataract Surgery
时间窗: 3 Months
Macular edema (thickening of the center of the back of the eye) was defined as 30% or greater increase from pre-operative baseline measurement in central subfield macular thickness as measured using Optical Coherence Tomography(OCT).
次要结局
- Percent of Patients With a Decrease of More Than 5 Letters in Best-corrected Visual Acuity (BCVA).(From Day 7 to Day 90 (or Early Exit))