Session Title: Miscellaneous
Session Date/Time: Thursday 17/09/2015 | 11:00-12:30
Paper Time: 11:32
First Author: : A.Pollack ISRAEL
Co Author(s): : R. Lehmann A. Narvekar A. Adewale R. Singh
PURPOSE:Nepafenac, a nonsteroidal anti-inflammatory drug (NSAID), is routinely used to relieve pain and inflammation associated with cataract surgery. NSAIDs are being investigated for potential therapeutic benefits in management of certain retinal conditions such as macular edema (ME) of various etiologies. The primary results of this study, reported previously, demonstrated that nepafenac 0.1% reduced the risk ME development following cataract surgery in diabetic retinopathy patients. The aim of this post-hoc analysis was to evaluate the visual acuity outcomes with 0.1% nepafenac instilled three times daily over 90 days to prevent macular edema following cataract surgery in diabetic retinopathy patients.
A prospective, multicenter, randomized, double-masked, vehicle-controlled parallel-group study (NCT00782717) was conducted in diabetic patients with non-proliferative diabetic retinopathy (NPDR) who required cataract extraction with planned implantation of posterior chamber intraocular lens.
Adult diabetic patients with NPDR were randomized (1:1) to topical 0.1% nepafenac or vehicle three times daily in the study eye beginning a day before surgery and continuing for 90 days postoperatively. In addition, all patients received a topical ocular steroid (prednisolone acetate) for two weeks postoperatively with the investigator’s discretion to continue thereafter. The primary outcome (proportion of patients who developed macular edema within 90 days postoperatively) and the other protocol-specified best-corrected visual acuity (BCVA) outcomes have been reported previously. A post-hoc analysis was conducted to assess the proportion of patients with an improvement of ≥15 letters in BCVA from preoperative baseline to Day 90; the proportion of patients who attained an improvement of ≥15 letters from preoperative baseline to Day 14 and maintained it to Day 90; and lastly the proportion of patients who had a loss of >10 letters from Day 7 to each subsequent visit. BCVA assessments were conducted at baseline and on postoperative Days 1, 7, 14, 30, 60, and 90 (or early exit). Patients with missing BCVA assessment at a specific visit were deemed to have a negative outcome for that visit and analysis (i.e. gain of <15 letters or loss of >10 letters).
Of the 263 patients enrolled, 251 patients were included in the intent-to-treat population; of these, 125 received 0.1% nepafenac and 126 received vehicle. At baseline, the preoperative mean BCVA was similar for the nepafenac and vehicle groups (68.2 and 66.7 letters). The proportion of patients with an improvement of ≥15 letters in BCVA from the preoperative baseline to Day 90 was significantly higher in the nepafenac group than in the vehicle group (55.2% vs 34.9%, p = 0.001). Similarly, a significantly higher proportion of patients in the nepafenac group showed an improvement of ≥15 letters in BCVA from preoperative baseline to Day 14 and maintained the improvement at each assessment time point through Day 90 (nepafenac: 38.4%, vehicle: 22.2%; p = 0.006). On the other hand, a lower proportion of nepafenac-treated patients experienced a BCVA loss of >10 letters from Day 7 to each subsequent visit compared with vehicle-treated patients (Day 14: 0.8% vs 9.5%, p = 0.014; Day 30: 2.4% vs 14.3%, p = 0.003; Day 60: 4.8% vs 11.9%, p = 0.05; and Day 90: 5.6% vs 20.6%, p<0.001 in the nepafenac and vehicle groups, respectively).
The post-hoc analysis of BCVA data from this study demonstrated a clear improvement and maintenance of BCVA with nepafenac in diabetic patients with NPDR. A significantly higher proportion of nepafenac-treated patients gained ≥15 letters from preoperative baseline to the early postoperative period (Day 14), and this was maintained through 3 months post-surgery (study exit). In addition, a higher proportion of patients in the nepafenac group gained ≥15 letters from preoperative baseline to subsequent postoperative visits from Day 14 to Day 90. On the other hand, fewer patients in the nepafenac group had a loss of >10 letters during the follow-up visit on day 7 to the subsequent visits (day 14, 30, 60) until day 90 compared with the vehicle group.