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Journal of Ophthalmology
Volume 2014, Article ID 857148, 9 pages
http://dx.doi.org/10.1155/2014/857148
Clinical Study

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

1Department of Ophthalmology, University Hospitals Coventry & Warwickshire NHS Trust, Coventry, West Midlands CV2 2DX, UK
2Institute of Eye Surgery and Macular Pigment Research Group, Whitfield Eye Clinic, Waterford, Ireland
3Department of Ophthalmology, Faculty Hospital, Vojtecha Spanyola 43, 012 07 Zilina, Slovakia
4Hospital Provincial Divino Valles, Avenida Islas Baleares 1, 09006 Burgos, Spain
5Oogcentrum Oostende, Koninginnelaan 54, 8400 Oostende, Belgium
6Novartis Pharma AG, CH-4002 Basel, Switzerland

Received 23 December 2013; Revised 7 March 2014; Accepted 12 March 2014; Published 28 April 2014

Academic Editor: Timothy Y. Lai

Copyright © 2014 Sergio Pagliarini et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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.