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. 2014:2014:857148.
doi: 10.1155/2014/857148. Epub 2014 Apr 28.

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

Sergio Pagliarini  1 , Stephen Beatty  2 , Blandina Lipkova  3 , Eduardo Perez-Salvador Garcia  4 , Stefaan Reynders  5 , Margarita Gekkieva  6 , Abdelkader Si Bouazza  6 , Stefan Pilz  6
Affiliations

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

Sergio Pagliarini et al. J Ophthalmol. 2014.

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.

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Figures

Figure 1
Figure 1
Patient disposition (all enrolled patients). *Except for one, none of the deaths were suspected to be related to the study treatment.
Figure 2
Figure 2
(a) Overall mean change in BCVA over time in the first-treated eye and (b) mean change in BCVA overtime based on the number of injections in the first-treated eye (safety set, LOCF). Safety set was defined as all those patients who were treated with at least one dose of ranibizumab and who had at least one safety assessment after study entry and no protocol deviations that warranted exclusion. Baseline VA results were recorded for 680 patients. Month 24 results were evaluated for 673 patients using the LOCF approach. BCVA: best-corrected visual acuity; LOCF: last observation carried forward.
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