Macular Edema Incidence/Severity Reduction With Nevanac
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Percentage of patients who develop macular edema within 90 days following cataract surgery
研究概览
简要总结
The purpose of this study is to evaluate NEVANAC in patients with diabetic retinopathy who developed macular edema (ME) within 90 days following cataract surgery.
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
- 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
- •Planned cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens (IOL) into the lens capsule.
- •History of Type 1 or Type 2 diabetes.
- •History of nonproliferative diabetic retinopathy (NPDR), mild, moderate, or severe, in the study eye as defined by the International Clinical Diabetic Retinopathy Disease Severity Scale.
- •Able to understand and sign an informed consent approved by an IRB/IEC.
- •Central subfield macular thickness less than or equal to 320 μm in the study eye prior to cataract surgery.
- •Absence of clinically significant macular edema in the study eye as detected by clinical exam.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Signs of vitreomacular traction or epiretinal membrane in the study eye as detected by the reading center or Investigator.
- •Current or previous ocular disease other than diabetic retinopathy in the study eye that, in the opinion of the Investigator, would have confounded the assessments of the macula, the retina, or central vision.
- •Planned multiple procedures for the study eye during the cataract/IOL implantation surgery (eg, trabeculoplasty, corneal transplant).
- •Corneal transplant in study eye.
- •Baseline cumulative corneal fluorescein staining score (ie, sum of scores for all 5 corneal regions) for the study eye greater than or equal to 5, or baseline corneal fluorescein staining score in any single region for the study eye greater than or equal to
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
NEVANAC
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
干预措施: Nepafenac ophthalmic suspension, 0.1% (NEVANAC®) (Drug)
Nepafenac Vehicle
One drop instilled in the study eye 3 times daily (morning, midafternoon, and bedtime) beginning the day before surgery, continuing on the day of surgery and through the first 90 days following surgery
干预措施: Nepafenac ophthalmic suspension vehicle (Drug)
结局指标
主要结局
Percentage of patients who develop macular edema within 90 days following cataract surgery
时间窗: Time to event
次要结局
- Mean change in best-corrected visual acuity (BCVA) from baseline to Day 90(Baseline, Day 90)