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

Abstract

BackgroundThe 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.MethodsThis 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.ResultsA 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.ConclusionNepafenac 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.

Topical Nonsteroidal Anti-inflammatory Drugs and Cataract Surgery

“…Furthermore, several studies may have favored NSAID treatment by preferentially pretreating a group of eyes with an NSAID, but in turn, not pretreating comparison eyes with an alternative anti-inflammatory medication. 15e18, 23,30 In other studies, some eyes were treated with both an NSAID and a corticosteroid and then compared with eyes treated with a corticosteroid alone without any adjustment made for dosing disparities. For example, in the study by Wittpenn et al, 23 patients in the ketorolac plus steroid group received dosing of both medications 4 times daily (8 total applications) compared with only 4 applications of the corticosteroid in the steroid only group.…”

Prospective randomised clinical trial to evaluate the safety and efficacy of nepafenac 0.1% treatment for the prevention of macular oedema associated with cataract surgery in patients with diabetic retinopathy

“…Patients were evaluated on day 1, day 7, day 14, day 30, day 60 and day 90 (or at time of early discontinuation from the study (ie, early exit)). Investigators determined whether patients should be discontinued from the study based on occurrence of the following criteria: CSMT increase of 30% or more from baseline,18 19 best-corrected visual acuity (BCVA) decreases considered by the investigator to be associated with retinal thickening or presence of cystoid abnormalities detected by spectral domain OCT (SD-OCT).…”

“…The primary objectives of this study were to evaluate the safety and efficacy of nepafenac 0.1% for the prevention of MO (defined as ≥30% increase in central subfield macular thickness (CSMT) from baseline18 19) when used for 90 days following cataract surgery in patients with DR.…”

Outcomes of cataract surgery in diabetic patients: results of the Pan American Collaborative Retina Study Group

“…Intravitreal anti-VEGF (bevacizumab or ranibizumab) (15)(16)(17)(18)(19)(20) and intravitreal steroids (triamcinolone acetonide or dexamethasone implant) (20)(21)(22) have been reported to achieve positive anatomical and functional results when injected immediately after the surgical procedure. More recently, the efficacy of topical non-steroidal anti-inflammatory drugs has also been reported (23) . In the present study, we found a significant postoperative retinal thickness decrease in the group treated with 4 mg/0.1 ml of intraoperative triamcinolone, but during the follow-up these patients showed a significant increase in CST.…”