Twelve-month outcomes of ranibizumab for diabetic macular edema in routine clinical practice in Mexico

Abstract

Purpose: The purpose of this study was to evaluate visual acuity (VA) and central retinal thickness (CRT) outcomes in patients treated with ranibizumab for diabetic macular edema (DME) in a clinical setting in Mexico. Methods: A prospective, open-label, single-arm study was performed on 48 eyes of 34 patients with center-involving DME at four high-specialty ISSSTE hospitals in Mexico. Patients initially received a loading dose of three injections of ranibizumab followed by monthly monitoring based on VA and CRT to determine retreatment need. VA, CRT, early treatment diabetic retinopathy (DR) study (ETDRS) DR severity scale (DRSS) score, and number of injections were recorded at baseline and monthly for 12 months. Results: The mean VA, mean CRT, and mean DRSS score at baseline were 19 (± 14) ETDRS letters, 362 (± 98) µm and 50.59 (± 7.9). The mean VA change at 12 months was + 8.6 (± 4.3) letters (p < 0.001) from baseline. The proportion of eyes that gained ≥ 10 letters was 38.58% (n = 19) and 37.50% (n = 18) gained < 10 letters; 4.16% (n = 2) had no change; and 18.75% (n = 9) lost < 10 letters. At month 12, mean CRT change was −85.34 (± 32.1) µm (p < 0.001) and the DRSS score was 45.79 (± 7.9) (p < 0.001). Patients received a mean of 6.7 (± 2.2) injections over 12 months. Conclusion: Patients showed visual and anatomical improvement after receiving ranibizumab in a clinical setting in Mexico.