PMID- 26294963
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150821
LR  - 20220321
IS  - 2090-004X (Print)
IS  - 2090-0058 (Electronic)
IS  - 2090-004X (Linking)
VI  - 2015
DP  - 2015
TI  - Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World 
      Evidence in the Italian Population (PRIDE Study).
PG  - 324841
LID - 10.1155/2015/324841 [doi]
LID - 324841
AB  - 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-naive 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.
FAU - Menchini, Ugo
AU  - Menchini U
AD  - Department of Specialized Surgical Sciences, Eye Clinic, University of Florence, 
      50121 Florence, Italy.
FAU - Bandello, Francesco
AU  - Bandello F
AD  - Department of Ophthalmology, University Vita-Salute Scientific Institute, San 
      Raffaele, Via Olgettina, 20132 Milan, Italy.
FAU - De Angelis, Vincenzo
AU  - De Angelis V
AD  - A.O.R.N.A. Cardarelli, 80131 Naples, Italy.
FAU - Ricci, Federico
AU  - Ricci F
AD  - UOSD Patologie Retiniche, Fondazione PTV, Universita di Roma Tor Vergata, Viale 
      Oxford 81, 00133 Rome, Italy.
FAU - Bonavia, Luigi
AU  - Bonavia L
AD  - A.O. Polo Universitario Luigi Sacco, Universita degli Studi, Grassi 74, 20156 
      Milan, Italy.
FAU - Viola, Francesco
AU  - Viola F
AD  - U.O. Oculistica, Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, 
      Universita di Milano, 20122 Milan, Italy.
FAU - Muscianisi, Elisa
AU  - Muscianisi E
AD  - Novartis Farma S.p.A, 21040 Origgio, Italy.
FAU - Nicolo, Massimo
AU  - Nicolo M
AD  - Clinica Oculistica, DiNOGMI, Universita di Genova, IRCCS Azienda Ospedaliera 
      Universitaria "San Martino-IST", 16132 Genova, Italy ; Fondazione per la Macula 
      Onlus, 16121 Genova, Italy.
LA  - eng
PT  - Journal Article
DEP - 20150729
PL  - United States
TA  - J Ophthalmol
JT  - Journal of ophthalmology
JID - 101524199
PMC - PMC4532943
EDAT- 2015/08/22 06:00
MHDA- 2015/08/22 06:01
PMCR- 2015/07/29
CRDT- 2015/08/22 06:00
PHST- 2015/03/03 00:00 [received]
PHST- 2015/05/30 00:00 [accepted]
PHST- 2015/08/22 06:00 [entrez]
PHST- 2015/08/22 06:00 [pubmed]
PHST- 2015/08/22 06:01 [medline]
PHST- 2015/07/29 00:00 [pmc-release]
AID - 10.1155/2015/324841 [doi]
PST - ppublish
SO  - J Ophthalmol. 2015;2015:324841. doi: 10.1155/2015/324841. Epub 2015 Jul 29.