A post-hoc comparison of nepafenac (0.1%) and vehicle on improvement of visual acuity in patients with diabetic retinopathy after cataract surgery

Session Details

Session Title: Cataract Surgery Complications

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

Paper Time: 09:20

Venue: Boulevard A

First Author: : A.Pollack ISRAEL

Co Author(s): :    R. Lehmann   A. Narvekar   A. Adewale   R. Singh     

Abstract Details

Purpose:

Post-hoc analysis to evaluate visual acuity improvement outcomes in adult patients with diabetic retinopathy, when treated with nepafenac (0.1%) three times daily over 90 days for prevention of macular edema occurring after cataract surgery

Setting:

Prospective, multicenter, randomized, double-masked, parallel-group vehicle-controlled study (NCT00782717), conducted in diabetic patients with nonproliferative diabetic retinopathy (NPDR) who required cataract extraction with planned implantation of posterior chamber intraocular lens (IOL)

Methods:

Adult diabetic patients with NPDR were randomized in a 1:1 ratio to nepafenac (0.1%) and vehicle, dosed three times daily; starting the day before surgery and continuing for 90 days postoperatively. All patients received topical ocular steroid (prednisolone acetate-1%) for two weeks postoperatively, with investigator’s discretion to continue thereafter. The results on the primary endpoint, the percentage of patients who developed macular edema (ME) within 90 days post-surgery and other protocol-specified best-corrected visual acuity (BCVA) related endpoints have been previously reported. Post-hoc analyses were conducted to find the proportion of patients who had an improvement in BCVA of ≥15 letters from the pre-operative baseline to Day 90, proportion who attained an improvement of ≥15 letters from pre-operative baseline to Day 14 and maintained it to Day 90 and lastly, the proportion who had decreases of >10 letters from Day 7 to each subsequent visit. BCVA assessments were conducted at baseline and post-operative Days 1, 7, 14, 30, 60 and 90 (or early exit). Analyses were conducted using logistic regression. Patients with missing BCVA assessment at a specific visit were deemed to have a negative outcome for that visit and analysis, i.e. improvement of <15 letters or decrease of >10 letters.

Results:

Out of a total of 263 patients enrolled, 251 patients were included in the intent-to-treat (ITT) population; of these, 125 received nepafenac (0.1%) and 126 received vehicle. The ITT population was used for analysis of efficacy endpoints. The pre-operative mean BCVA was similar for both treatment groups (nepafenac – 68.2; vehicle – 66.7). A higher proportion of patients in the nepafenac group had improvements of ≥15 letters in BCVA from the pre-operative baseline to Day 90 when compared to the vehicle group (nepafenac – 55.2% and vehicle – 34.9%; P=0.001). A significantly higher proportion of patients in the nepafenac group showed an improvement of ≥15 letters in BCVA from pre-operative baseline to Day 14 and maintained the improvement at each assessment time point through Day 90 (nepafenac – 38.4% and vehicle – 22.2%; P=0.006). Also, a lower proportion of nepafenac-treated patients experienced BCVA decreases of >10 letters from Day 7 to each of Day 14, 30, 60 and 90 study visits compared to vehicle-treated patients (0.8% versus 9.5%, P=0.014, 2.4% versus 14.3%, P = 0.003, 4.8% versus 11.9%, P=0.05 and 5.6% versus 20.6%, P <0.001 at Day 14, 30, 60 and 90 in nepafenac and vehicle groups respectively).

Conclusions:

Nepafenac 0.1% has previously been reported to be efficacious in the prevention of macular edema and reduction of BCVA loss post cataract surgery in diabetic patients with NPDR. In an exploratory analysis of BCVA data from the same study, nepafenac demonstrated a benefit in improvement and maintenance of BCVA with a higher proportion of nepafenac treated patients gaining 15 letters or more from preoperative baseline to during the early postoperative period (Day 14) and maintaining it through 3 months post-surgery (study exit) compared to vehicle treated patients. The proportion of patients with gains of 15 letters or more from preoperative baseline was higher for nepafenac group at each postoperative visit from Day 14 to Day 90. Fewer patients in nepafenac group had a loss of greater than 10 letters from Day 7 visit at each subsequent postoperative visit till Day 90 compared to the vehicle group.

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