Clinical experience on intravitreal ranibizumab for DME on a real-life

Abstract

Purpose: To describe clinical applicability and efficacy of antiVEGF treatments for DME on a real life.

Methods: 32 patients with clinical significant diabetic macular edema at various stages have been enrolled in this prospective case series study. All patients have been evaluated by a complete ophthalmological and instrumental evaluation at baseline and every month for six months. Exclusion criteria were proliferative retinopathy, ocular inflammation, previous laser or cataract surgery less than 6 months. Each patient underwent intravitreal injection of ranibizumab as for approved indication. OCT and Snellen VA were scheduled monthly. We evaluated different adherence and quality parameters: time delay from the scheduled visits, number of visit for each patient and modality of access; clinical systemic parameters were also considered like HbA1c and fasting glucose (FG). First study outcome was the adherence to the scheduled treatment, second outcome was the effectiveness of the therapy.

Results: Each patient performed a mean of 5.5±0.9 visits during the follow up, with a mean delay of 7,3±4.2 days respect to the scheduled time. Mean number of injections was 4.94±2.1. About access modality 70% of patients reached our Clinic by public transportation, 60% involved more than one relative or companion. Systemic parameters were very variable among patients with a mean HbcA1 of 6.4±3.2 and FG of 7.4±0.73mmol/l. About treatment efficacy, visual acuity and macular thickness were respectively (mean±SD) 0.48±0.22 and 433.42±125.54 at baseline, 0.54±0.26 (p>0.05) and 388.90±134.79 (p<0.05) at month 1, 0.60±0.26 (p<0.05) and 337.50±111.75 (p<0.05) at month 3 and 0.62±0.23 (p<0.05) and 352.24±101.59 (p<0.05) at month 6.

Conclusions: A strict application of a monthly protocol treatment is difficult to implement on “a real-life”. Management deviations and clinical bias make the efficacy results of ranibizumab inferior to the published RCT data. However, our study showed significative results on macular edema control and function recovery.

Keywords: 499 diabetic retinopathy • 460 clinical (human) or epidemiologic studies: health care delivery/economics/manpower • 748 vascular endothelial growth factor