Efficacy and safety of nepafenac 0.1% (Nevanac) for the reduction in risk of macular edema (ME) following cataract surgery in patients with diabetic retinopathy: results from 2 multicenter trials

Session Details

Session Title: Cataract Surgery Complications

Session Date/Time: Monday 15/09/2014 | 08:00-10:30

Paper Time: 09:26

Venue: Boulevard A

First Author: : G.Staurenghi ITALY

Co Author(s): :    A. Pollack   D. Sager   R. Singh        

Abstract Details

Purpose:

To evaluate nepafenac ophthalmic suspension, 0.1% (NEVANAC) for risk reduction of macular edema (ME) and maintenance of best corrected visual acuity (BCVA) following cataract surgery in diabetic retinopathy patients.

Setting:

Two prospective multicenter clinical trials conducted in the US [Study 1 - NCT00782717] and US, Europe, India, New Zealand and Israel [Study 2 - NCT00939276].

Methods:

Two prospective multicenter randomized double-masked parallel group and vehicle-controlled studies were conducted in adult diabetic patients with nonproliferative diabetic retinopathy (NPDR) requiring cataract surgery. Patients without existing macular edema were randomized (1:1) to instill nepafenac or vehicle 3 times daily in the study eye beginning 1 day prior to surgery through day 90. All patients received steroid (prednisolone acetate 1% in Study 1 and dexamethasone 0.1% in Study 2) for two weeks postoperatively with investigator’s discretion to continue thereafter. The primary endpoint in both studies was the percentage of patients who developed ME (defined as a ≥30% increase in central subfield macular thickness from baseline at any post operative visit). In Study 1, retinal thickness was measured with time domain optical coherence tomography (TDOCT) (Stratus, Zeiss), while Study 2 used spectral domain optical coherence tomography (SDOCT) (Spectralis, Heidelberg). Secondary and additional study endpoints included the percentage of patients with decreases in best corrected visual acuity (BCVA) of greater than 5 letters from day 7 to 90, decreases greater than 10 letters from day 7 to any visit, and safety. The ITT dataset was used for analyses of efficacy endpoints.

Results:

Of 251 [Study 1] and 160 [Study 2] patients, a significantly greater percentage of patients developed ME in the vehicle group compared with the nepafenac group, within 90 days following cataract surgery (16.7% versus 3.2%, respectively; p<0.001 [Study 1]; 17.5% versus 5.0%, respectively; p=0.012 [Study 2]). At Day 90, mean change from baseline in central subfield macular thickness (CSMT) was lower upon nepafenac -treatment (8.6 µm, 95% CI [5.9, 11.4]-Study 1 and 11.1 µm, 95% CI [6.0, 16.3]- Study 2), as compared to vehicle-treatment (29.4 µm, 95% CI [20.6, 38.3]-Study 1 and 39.3 µm, 95% CI [28.7, 49.8]-Study 2). In both studies, a higher percentage of patients treated with vehicle experienced BCVA decrease of >5 letters from Day 7 to Day 90/exit visit compared to patients treated with nepafenac (11.5% versus 2.5% respectively; p=0.006 [Study 1] and 13.8% versus 6.3%, respectively; p=0.120 [Study 2]). In the subgroup that developed ME within 90 days, 48% [Study 1] and 50% [Study 2] treated with vehicle lost >10 letters of BCVA at one or more postoperative visits after day 7, compared with 0% of patients treated with nepafenac. No new safety issues were identified after extended use (up to 90 days) of nepafenac.

Conclusions:

Nepafenac demonstrated a statistically significant difference compared to vehicle for reducing the risk of ME occurrence in patients with diabetic retinopathy following cataract surgery. A benefit was also seen in maintaining visual acuity in patients treated with nepafenac. No new adverse events were identified in comparison to previous Nepafenac studies.

Financial Interest:

One or more of the authors... is employed by a forNONEprofit company with an interest in the subject of the presentation, One or more of the authors... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors... research is funded, fully or partially, by a competing company, One or more of the authors... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors... receives consulting fees, retainer, or contract payments from a competing company, One or more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented