Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study)
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 ranibizuma...
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| Format: | Article |
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Wiley
2015-01-01
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| Series: | Journal of Ophthalmology |
| Online Access: | http://dx.doi.org/10.1155/2015/324841 |
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| author | Ugo Menchini Francesco Bandello Vincenzo De Angelis Federico Ricci Luigi Bonavia Francesco Viola Elisa Muscianisi Massimo Nicolò |
| author_facet | Ugo Menchini Francesco Bandello Vincenzo De Angelis Federico Ricci Luigi Bonavia Francesco Viola Elisa Muscianisi Massimo Nicolò |
| author_sort | Ugo Menchini |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-138fa06cbf584c1a8ac8a6fd01a954d7 |
| institution | Kabale University |
| issn | 2090-004X 2090-0058 |
| language | English |
| publishDate | 2015-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Ophthalmology |
| spelling | doaj-art-138fa06cbf584c1a8ac8a6fd01a954d72025-02-03T01:13:05ZengWileyJournal of Ophthalmology2090-004X2090-00582015-01-01201510.1155/2015/324841324841Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study)Ugo Menchini0Francesco Bandello1Vincenzo De Angelis2Federico Ricci3Luigi Bonavia4Francesco Viola5Elisa Muscianisi6Massimo Nicolò7Department of Specialized Surgical Sciences, Eye Clinic, University of Florence, 50121 Florence, ItalyDepartment of Ophthalmology, University Vita-Salute Scientific Institute, San Raffaele, Via Olgettina, 20132 Milan, ItalyA.O.R.N.A. Cardarelli, 80131 Naples, ItalyUOSD Patologie Retiniche, Fondazione PTV, Università di Roma Tor Vergata, Viale Oxford 81, 00133 Rome, ItalyA.O. Polo Universitario Luigi Sacco, Università degli Studi, Grassi 74, 20156 Milan, ItalyU.O. Oculistica, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università di Milano, 20122 Milan, ItalyNovartis Farma S.p.A, 21040 Origgio, ItalyClinica Oculistica, DiNOGMI, Università di Genova, IRCCS Azienda Ospedaliera Universitaria “San Martino-IST”, 16132 Genova, ItalyPurpose. 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.http://dx.doi.org/10.1155/2015/324841 |
| spellingShingle | Ugo Menchini Francesco Bandello Vincenzo De Angelis Federico Ricci Luigi Bonavia Francesco Viola Elisa Muscianisi Massimo Nicolò Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study) Journal of Ophthalmology |
| title | Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study) |
| title_full | Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study) |
| title_fullStr | Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study) |
| title_full_unstemmed | Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study) |
| title_short | Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study) |
| title_sort | ranibizumab for visual impairment due to diabetic macular edema real world evidence in the italian population pride study |
| url | http://dx.doi.org/10.1155/2015/324841 |
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