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Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study)
Joint Authors
Viola, Francesco
Menchini, Ugo
De Angelis, Vincenzo
Ricci, Federico
Bonavia, Luigi
Muscianisi, Elisa
Nicolò, Massimo
Bandello, Francesco
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-07-29
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
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.
American Psychological Association (APA)
Menchini, Ugo& Bandello, Francesco& De Angelis, Vincenzo& Ricci, Federico& Bonavia, Luigi& Viola, Francesco…[et al.]. 2015. Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study). Journal of Ophthalmology،Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1069698
Modern Language Association (MLA)
Menchini, Ugo…[et al.]. Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study). Journal of Ophthalmology No. 2015 (2015), pp.1-10.
https://search.emarefa.net/detail/BIM-1069698
American Medical Association (AMA)
Menchini, Ugo& Bandello, Francesco& De Angelis, Vincenzo& Ricci, Federico& Bonavia, Luigi& Viola, Francesco…[et al.]. Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study). Journal of Ophthalmology. 2015. Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1069698
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1069698