Características basales de los pacientes tratados con Ranibizumab intravítreo, por edema macular diabético en ensayos clínicos y práctica clínica habitual

Abstract

Objective: Our purpose is to study and compare the baseline characteristics of patients who started treatment with Ranibizumab for EMD in our clinical practice with RCT and other clinical practice publications. Material and Methods: Retrospective study during 2016. We collected the baseline characteristics of all naive patients ( those ones who have never had a specific treatment before) who started treatment with Ranibizumab for EMD in our center. And we compare our results with the following RCTs: Protocol I and T of the DRCR, RISE & RIDE, RESTORE; and with studies of usual clinical practice: LUMINOUS and OCEAN. Results: We collected 53 patients: 29 women (55%). The average age was 64.5+/-13 years (51.5, 77.5). The age of our patients was higher compared to the RCTs, and lower compared to the LUMINOUS. The severity of diabetic retinopathy was similar to the RCTs. The initial VA and the CST were comparable to the usual clinical practice studies. Conclusions: The baseline characteristics of patients starting treatment with Ranibizumab for EMD in our usual clinical practice is similar to that of patients included in randomized clinical trials and other clinical practice studies