Topical nepafenec in eyes with noncentral diabetic macular edema

Abstract

Purpose: To evaluate the effect of a topical, nonsteroidal antiinflammatory drug, nepafenac 0.1%, in eyes with noncentral diabetic macular edema.

Methods: Multicenter, double-masked randomized trial. Individuals with good visual acuity and noncentral-involved diabetic macular edema were randomly assigned to nepafenac 0.1% (N = 61) or placebo (nepafenac vehicle, N = 64) 3 times a day for 12 months. The primary outcome was mean change in optical coherence tomography retinal volume at 12 months.

Results: Mean baseline retinal volume was 7.8 mm. At 12 months, in the nepafenac and placebo groups respectively, mean change in retinal volume was -0.03 mm and -0.02 mm (treatment group difference: -0.02, 95% confidence interval: -0.27 to 0.23, P = 0.89). Central-involved diabetic macular edema was present in 7 eyes (11%) and 9 eyes (14%) at the 12-month visit (P = 0.79), respectively. No differences in visual acuity outcomes were identified. One study participant developed a corneal melt after using nepafenac in the nonstudy eye, which had a history of severe dry eye. No additional safety concerns were evident.

Conclusion: In eyes with noncentral diabetic macular edema and good visual acuity, topical nepafenac 0.1% 3 times daily for 1 year likely does not have a meaningful effect on optical coherence tomography-measured retinal thickness.

Figure 1

OCT threshold values to define eligibility in Zeiss Cirrus (Zeiss, Personal Communication, December 15, 2010) (A) and Heidelberg Spectralis (B) machines. Values in top row (bold font) are women-specific, and values in bottom row (regular font) are men-specific. Threshold is defined as the mean OCT thickness value from normal cohort+ 2 standard deviations (SD). For eligibility, study eye must have had central subfield thickness below the threshold, and meeting one of the following: 1) At least 2 non-central subfields with thickness values above threshold; or 2) At least 1 non-central subfield with thickness value more than 15 μm above threshold.

Figure 1

OCT threshold values to define eligibility in Zeiss Cirrus (Zeiss, Personal Communication, December 15, 2010) (A) and Heidelberg Spectralis (B) machines. Values in top row (bold font) are women-specific, and values in bottom row (regular font) are men-specific. Threshold is defined as the mean OCT thickness value from normal cohort+ 2 standard deviations (SD). For eligibility, study eye must have had central subfield thickness below the threshold, and meeting one of the following: 1) At least 2 non-central subfields with thickness values above threshold; or 2) At least 1 non-central subfield with thickness value more than 15 μm above threshold.

Figure 2

Summary of Study Recruitment.

Figure 3

Optical Coherence Tomography retinal volume data (last observation carried forward). A: mean time-domain-equivalent retinal volume (mm³). B: mean retinal volume change from baseline (mm³). Error bars represent 95% confidence limit.

Figure 3

Optical Coherence Tomography retinal volume data (last observation carried forward). A: mean time-domain-equivalent retinal volume (mm³). B: mean retinal volume change from baseline (mm³). Error bars represent 95% confidence limit.