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
المؤلفون المشاركون
Pagliarini, Sergio
Lipkova, Blandina
Perez-Salvador Garcia, Eduardo
Reynders, Stefaan
Gekkieva, Margarita
Si Bouazza, Abdelkader
Pilz, Stefan
Beatty, Stephen
المصدر
العدد
المجلد 2014، العدد 2014 (31 ديسمبر/كانون الأول 2014)، ص ص. 1-9، 9ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2014-04-28
دولة النشر
مصر
عدد الصفحات
9
التخصصات الرئيسية
الملخص EN
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.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Pagliarini, Sergio& Beatty, Stephen& Lipkova, Blandina& Perez-Salvador Garcia, Eduardo& Reynders, Stefaan& Gekkieva, Margarita…[et al.]. 2014. 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،Vol. 2014, no. 2014, pp.1-9.
https://search.emarefa.net/detail/BIM-1042638
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Pagliarini, Sergio…[et al.]. 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 No. 2014 (2014), pp.1-9.
https://search.emarefa.net/detail/BIM-1042638
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Pagliarini, Sergio& Beatty, Stephen& Lipkova, Blandina& Perez-Salvador Garcia, Eduardo& Reynders, Stefaan& Gekkieva, Margarita…[et al.]. 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. 2014. Vol. 2014, no. 2014, pp.1-9.
https://search.emarefa.net/detail/BIM-1042638
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1042638
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر