Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy

Abstract

Background: The purpose of this study was to evaluate nepafenac ophthalmic suspension 0.1% (Nevanac(®); Alcon Research Ltd) in the prevention of macular edema following cataract surgery in diabetic retinopathy patients.

Methods: This was a multicenter, randomized, double-masked, vehicle-controlled study of 263 adult diabetic patients with nonproliferative diabetic retinopathy requiring cataract surgery. Patients were randomized (1:1) to instill nepafenac or vehicle three times daily beginning 1 day prior to surgery through day 90. Efficacy included the percentage of patients who developed macular edema (≥30% increase in central subfield macular thickness from baseline) and the percentage of patients with decreases of more than five letters in best-corrected visual acuity from day 7 to 90.

Results: A significantly lower percentage of patients in the nepafenac group developed macular edema relative to patients in the vehicle group (3.2% versus 16.7%; P < 0.001). A significantly lower percentage of patients in the nepafenac group had best-corrected visual acuity decreases of more than five letters relative to patients in the vehicle group on day 30 (P < 0.001), day 60 (P = 0.002), and day 90 (P = 0.006). The mean central subfield macular thickness and mean percent change from baseline in macular volume were also significantly lower in the nepafenac group versus the vehicle group at days 14 through 90 (P ≤ 0.005). No safety issues or trends were identified when dosing was increased to 90 days that negatively impacted the favorable benefit/risk profile of nepafenac.

Conclusion: Nepafenac demonstrated statistically significant and clinically relevant advantages compared with vehicle in preventing macular edema and maintaining visual acuity in diabetic patients following cataract surgery. These advantages were seen at multiple time points over the course of the 90-day therapy period. There was no clinically relevant increase in risk from 90 days dosing compared with 14 days. Therefore, with a similar safety profile and benefit in preventing macular edema and maintaining vision, the risk/benefit to the diabetic patient undergoing cataract surgery appears to be positive.

Keywords: cataract extraction; diabetes; macular edema; nonsteroidal anti-inflammatory drug; ocular surgery; retinopathy; topical.

Figures

Figure 1

Mean central subfield macular thickness (intent-to-treat data). Notes: Data are presented as the mean thickness in microns ± standard error. The study day identified as “B” represents the presurgical baseline. The sample sizes in the nepafenac group were 125 (baseline, and days 14, 30, 60, and 90) and 121 (day 7); the sample sizes in the vehicle group were 126 (baseline, and days 30, 60, and 90), 124 (day 7), and 125 (day 14). *On days 14, 30, 60, and 90, the difference between nepafenac and vehicle is significant (P < 0.001 in all comparisons based on a repeated-measures analysis of variance).

Figure 2

Mean percent change from presurgical baseline in macular volume (intent-to-treat data). Notes: Data are presented as the mean percent change in volume ± standard error. The sample sizes in the nepafenac group were 121 (day 7) and 125 (days 14, 30, 60, and 90); the sample sizes in the vehicle group were 124 (day 7), 125 (day 14), and 126 (days 30, 60, and 90). *On days 14, 30, 60, and 90, the difference between nepafenac and vehicle is significant (P = 0.005 for day 14 and P < 0.001 for days 30, 60, and 90, based on a repeated-measures analysis of variance).

Figure 3

Mean best-corrected visual acuity (intent-to-treat data). Notes: Data are presented as the mean number of letters read ± standard error. The study day identified as “B” represents the presurgical baseline. No P-values were calculated. The sample sizes in the nepafenac group were 125 (baseline, and days 14, 30, 60, and 90) and 124 (day 7); the sample sizes in the vehicle group were 124 (baseline), 123 (days 7 and 30), 122 (day 14), and 125 (days 60 and 90).