Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Lehmann Eye Center, Nacogdoches, Texas.
Ophthalmology. 2017 Jun;124(6):776-785. doi: 10.1016/j.ophtha.2017.01.036. Epub 2017 Mar 6.
To demonstrate the efficacy and safety of once-daily nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes.
Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies.
Total, 615 patients in study 1 and 605 patients in study 2.
Patients were randomized (1:1) to topical nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter.
Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months.
A significantly lower percentage of patients demonstrated ME within 90 days after surgery with nepafenac 0.3% versus vehicle (study 1: 2.3% vs. 17.3%; P < 0.001; study 2: 5.9% vs. 14.3%; P = 0.001; pooled: 4.1% vs. 15.9%; P < 0.001). The percentage of patients achieving a ≥15-letter improvement from baseline through day 14 maintained through day 90 with nepafenac 0.3% versus vehicle was 61.7% versus 43.0% (P < 0.001) in study 1, 48.8% versus 50.5% (P = 0.671) in study 2, and 55.4% versus 46.7% (P = 0.003) in the pooled analysis. A greater percentage of patients treated with nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [P = 0.009] and 65.4% vs. 65.9% [P = 0.888]) and through day 60 (76.2% vs. 64.7% [P = 0.002] and 68.9% vs. 62.1% [P = 0.092]). No unanticipated adverse events were observed.
These studies demonstrated the clinical benefits of nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events.
展示在糖尿病患者白内障手术后，与载体相比，每日一次使用奈帕芬那 0.3%眼用悬浮液的临床疗效和安全性。
两项前瞻性、随机、多中心、双盲、载体对照的 3 期研究。
总共 615 例患者参加了研究 1，605 例患者参加了研究 2。
患者随机（1:1）接受每日一次的 topical nepafenac 0.3%或载体治疗，在手术前一天开始，并在术后 90 天内持续使用。
关键疗效变量为：白内障手术后 90 天内出现黄斑水肿（ME）的患者比例（与术前中央小视野黄斑厚度相比增加≥30%）和术后 14 天内从术前基线开始视力矫正最佳视力（BCVA）提高≥15 个字母并持续至第 90 天的患者比例。次要终点包括：白内障手术后 90 天和 60 天内从术前基线开始 BCVA 提高≥15 个字母的患者比例以及 3 个月的安全性。
与载体相比，使用奈帕芬那 0.3%的患者在白内障手术后 90 天内出现 ME 的比例显著降低（研究 1：2.3% vs. 17.3%；P < 0.001；研究 2：5.9% vs. 14.3%；P = 0.001；汇总：4.1% vs. 15.9%；P < 0.001）。与载体相比，使用奈帕芬那 0.3%的患者在术后 14 天内从基线开始的 BCVA 提高≥15 个字母，并持续至第 90 天的比例在研究 1 中为 61.7% vs. 43.0%（P < 0.001），在研究 2 中为 48.8% vs. 50.5%（P = 0.671），在汇总分析中为 55.4% vs. 46.7%（P = 0.003）。与载体相比，更多接受奈帕芬那 0.3%治疗的患者在研究 1 和研究 2 中在白内障手术后 90 天内（77.2% vs. 67.7% [P = 0.009]和 65.4% vs. 65.9% [P = 0.888]）和 60 天内（76.2% vs. 64.7% [P = 0.002]和 68.9% vs. 62.1% [P = 0.092]）BCVA 提高≥15 个字母。未观察到意外的不良事件。
这些研究表明，与载体相比，奈帕芬那 0.3%在降低术后 ME 风险方面具有临床优势，综合分析显示，糖尿病视网膜病变患者白内障手术后的 BCVA 得到改善，且未出现意外的安全性事件。
