PMID- 24868458
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20140528
LR  - 20211021
IS  - 2090-004X (Print)
IS  - 2090-0058 (Electronic)
IS  - 2090-004X (Linking)
VI  - 2014
DP  - 2014
TI  - 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.
PG  - 857148
LID - 10.1155/2014/857148 [doi]
LID - 857148
AB  - 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.
FAU - Pagliarini, Sergio
AU  - Pagliarini S
AUID- ORCID: 0000-0003-3839-7851
AD  - Department of Ophthalmology, University Hospitals Coventry & Warwickshire NHS 
      Trust, Coventry, West Midlands CV2 2DX, UK.
FAU - Beatty, Stephen
AU  - Beatty S
AD  - Institute of Eye Surgery and Macular Pigment Research Group, Whitfield Eye 
      Clinic, Waterford, Ireland.
FAU - Lipkova, Blandina
AU  - Lipkova B
AUID- ORCID: 0000-0002-5754-7547
AD  - Department of Ophthalmology, Faculty Hospital, Vojtecha Spanyola 43, 012 07 
      Zilina, Slovakia.
FAU - Perez-Salvador Garcia, Eduardo
AU  - Perez-Salvador Garcia E
AD  - Hospital Provincial Divino Valles, Avenida Islas Baleares 1, 09006 Burgos, Spain.
FAU - Reynders, Stefaan
AU  - Reynders S
AD  - Oogcentrum Oostende, Koninginnelaan 54, 8400 Oostende, Belgium.
FAU - Gekkieva, Margarita
AU  - Gekkieva M
AUID- ORCID: 0000-0003-1043-4382
AD  - Novartis Pharma AG, CH-4002 Basel, Switzerland.
FAU - Si Bouazza, Abdelkader
AU  - Si Bouazza A
AD  - Novartis Pharma AG, CH-4002 Basel, Switzerland.
FAU - Pilz, Stefan
AU  - Pilz S
AD  - Novartis Pharma AG, CH-4002 Basel, Switzerland.
LA  - eng
PT  - Journal Article
DEP - 20140428
PL  - United States
TA  - J Ophthalmol
JT  - Journal of ophthalmology
JID - 101524199
PMC - PMC4020221
EDAT- 2014/05/29 06:00
MHDA- 2014/05/29 06:01
PMCR- 2014/04/28
CRDT- 2014/05/29 06:00
PHST- 2013/12/23 00:00 [received]
PHST- 2014/03/07 00:00 [revised]
PHST- 2014/03/12 00:00 [accepted]
PHST- 2014/05/29 06:00 [entrez]
PHST- 2014/05/29 06:00 [pubmed]
PHST- 2014/05/29 06:01 [medline]
PHST- 2014/04/28 00:00 [pmc-release]
AID - 10.1155/2014/857148 [doi]
PST - ppublish
SO  - J Ophthalmol. 2014;2014:857148. doi: 10.1155/2014/857148. Epub 2014 Apr 28.