title: Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study).
abstract: Purpose. An expanded access program (PRIDE study) in Italy to provide ranibizumab 0.5 mg to diabetic macular edema (DME) patients, prior to reimbursement. Methods. Open-label, prospective, phase IIIb study. Majority of patients were not treatment-naïve before enrollment. Patients received ranibizumab as per the EU label (2011). Safety was assessed by incidences of ocular/systemic adverse events (AEs) and serious AEs (SAEs) and efficacy in terms of visual acuity (VA) change from baseline (decimal score or Snellen (20/value)). Results. Overall, 515 patients (83.5%) completed the study. In unilateral/bilateral patients, commonly observed AEs were cardiac disorders (1.3%/1.3%) and nervous system disorders (1.3%/1.1%); SAEs were reported in 4.5%/4.8% of patients. Acute renal failure, lung carcinoma, and cardiac arrest were the causes of death in one unilateral and two bilateral patients. Ranibizumab improved/maintained VA (Snellen (20/value)/decimal scores) in both unilateral (up to -16.7/1.5) and bilateral patients (up to -23.6/1.2) at Month 5, with a mean of 4.15 and 4.40 injections, respectively. Overall, no difference was observed in the VA outcomes and treatment exposure between unilateral/bilateral patients. Conclusions. The PRIDE study provided early ranibizumab access to >600 Italian patients. Ranibizumab was well-tolerated and improved/maintained VA in 40.2%-68.8% patients, with no differences in case of unilateral or bilateral pathology. The study is registered with EudraCT.
authors: Department of Specialized Surgical Sciences, Eye Clinic, University of Florence, 50121 Florence, Italy.
authors: Ugo
authors: U
authors: Menchini
authors: Department of Ophthalmology, University Vita-Salute Scientific Institute, San Raffaele, Via Olgettina, 20132 Milan, Italy.
authors: Francesco
authors: F
authors: Bandello
authors: A.O.R.N.A. Cardarelli, 80131 Naples, Italy.
authors: Vincenzo
authors: V
authors: De Angelis
authors: UOSD Patologie Retiniche, Fondazione PTV, Università di Roma Tor Vergata, Viale Oxford 81, 00133 Rome, Italy.
authors: Federico
authors: F
authors: Ricci
authors: A.O. Polo Universitario Luigi Sacco, Università degli Studi, Grassi 74, 20156 Milan, Italy.
authors: Luigi
authors: L
authors: Bonavia
authors: U.O. Oculistica, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università di Milano, 20122 Milan, Italy.
authors: Francesco
authors: F
authors: Viola
authors: Novartis Farma S.p.A, 21040 Origgio, Italy.
authors: Elisa
authors: E
authors: Muscianisi
authors: Clinica Oculistica, DiNOGMI, Università di Genova, IRCCS Azienda Ospedaliera Universitaria "San Martino-IST", 16132 Genova, Italy ; Fondazione per la Macula Onlus, 16121 Genova, Italy.
authors: Massimo
authors: M
authors: Nicolò