A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study
Purpose. To assess the safety profile of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. Methods. This 2-year, multicentre, observational study was conducted to capture real-world early practice and outcomes across Europe, shortly...
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2014-01-01
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| Series: | Journal of Ophthalmology |
| Online Access: | http://dx.doi.org/10.1155/2014/857148 |
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| author | Sergio Pagliarini Stephen Beatty Blandina Lipkova Eduardo Perez-Salvador Garcia Stefaan Reynders Margarita Gekkieva Abdelkader Si Bouazza Stefan Pilz |
| author_facet | Sergio Pagliarini Stephen Beatty Blandina Lipkova Eduardo Perez-Salvador Garcia Stefaan Reynders Margarita Gekkieva Abdelkader Si Bouazza Stefan Pilz |
| author_sort | Sergio Pagliarini |
| collection | DOAJ |
| description | Purpose. To assess the safety profile of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. Methods. This 2-year, multicentre, observational study was conducted to capture real-world early practice and outcomes across Europe, shortly after European licensing of ranibizumab for nAMD. Being observational in nature, the study did not impose diagnostic/therapeutic interventions/visit schedule. Patients were to be treated as per the EU summary of product characteristics (SmPC) in effect during the study. Key outcome measures were incidence of selected adverse events (AEs), treatment exposure, bilateral treatment, compliance to the EU SmPC, and best-corrected visual acuity (BCVA) over 2 years.
Results. 755 of 770 patients received treatment. Ranibizumab was generally well tolerated with low incidence of selected AEs (0%–1.9%). Patients received 6.2 (mean) injections and 133 patients received bilateral treatment over 2 years. Protocol deviation to treatment compliance was reported in majority of patients. The observed decline in mean BCVA (Month 12, +1.5; Month 24, –1.3 letters) may be associated with undertreatment as suggested by BCVA subgroup analysis. Conclusion. The EPICOHORT study conducted in routine clinical practice reinforces the well-established safety profile of ranibizumab in nAMD. In early European practice it appeared that the nAMD patients were undertreated. |
| format | Article |
| id | doaj-art-221f84d48af648ad8957a3aa064cb234 |
| institution | Kabale University |
| issn | 2090-004X 2090-0058 |
| language | English |
| publishDate | 2014-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Ophthalmology |
| spelling | doaj-art-221f84d48af648ad8957a3aa064cb2342025-02-03T06:11:12ZengWileyJournal of Ophthalmology2090-004X2090-00582014-01-01201410.1155/2014/857148857148A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT StudySergio Pagliarini0Stephen Beatty1Blandina Lipkova2Eduardo Perez-Salvador Garcia3Stefaan Reynders4Margarita Gekkieva5Abdelkader Si Bouazza6Stefan Pilz7Department of Ophthalmology, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, West Midlands CV2 2DX, UKInstitute of Eye Surgery and Macular Pigment Research Group, Whitfield Eye Clinic, Waterford, IrelandDepartment of Ophthalmology, Faculty Hospital, Vojtecha Spanyola 43, 012 07 Zilina, SlovakiaHospital Provincial Divino Valles, Avenida Islas Baleares 1, 09006 Burgos, SpainOogcentrum Oostende, Koninginnelaan 54, 8400 Oostende, BelgiumNovartis Pharma AG, CH-4002 Basel, SwitzerlandNovartis Pharma AG, CH-4002 Basel, SwitzerlandNovartis Pharma AG, CH-4002 Basel, SwitzerlandPurpose. To assess the safety profile of ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (nAMD) in routine clinical practice. Methods. This 2-year, multicentre, observational study was conducted to capture real-world early practice and outcomes across Europe, shortly after European licensing of ranibizumab for nAMD. Being observational in nature, the study did not impose diagnostic/therapeutic interventions/visit schedule. Patients were to be treated as per the EU summary of product characteristics (SmPC) in effect during the study. Key outcome measures were incidence of selected adverse events (AEs), treatment exposure, bilateral treatment, compliance to the EU SmPC, and best-corrected visual acuity (BCVA) over 2 years. Results. 755 of 770 patients received treatment. Ranibizumab was generally well tolerated with low incidence of selected AEs (0%–1.9%). Patients received 6.2 (mean) injections and 133 patients received bilateral treatment over 2 years. Protocol deviation to treatment compliance was reported in majority of patients. The observed decline in mean BCVA (Month 12, +1.5; Month 24, –1.3 letters) may be associated with undertreatment as suggested by BCVA subgroup analysis. Conclusion. The EPICOHORT study conducted in routine clinical practice reinforces the well-established safety profile of ranibizumab in nAMD. In early European practice it appeared that the nAMD patients were undertreated.http://dx.doi.org/10.1155/2014/857148 |
| spellingShingle | Sergio Pagliarini Stephen Beatty Blandina Lipkova Eduardo Perez-Salvador Garcia Stefaan Reynders Margarita Gekkieva Abdelkader Si Bouazza Stefan Pilz A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study Journal of Ophthalmology |
| title | A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study |
| title_full | A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study |
| title_fullStr | A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study |
| title_full_unstemmed | A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study |
| title_short | A 2-Year, Phase IV, Multicentre, Observational Study of Ranibizumab 0.5 mg in Patients with Neovascular Age-Related Macular Degeneration in Routine Clinical Practice: The EPICOHORT Study |
| title_sort | 2 year phase iv multicentre observational study of ranibizumab 0 5 mg in patients with neovascular age related macular degeneration in routine clinical practice the epicohort study |
| url | http://dx.doi.org/10.1155/2014/857148 |
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