Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial
Joint Authors
Ziemssen, Focke
Wachtlin, Joachim
Vögeler, Jessica
Müller, Bettina
Ocean study group, Focke
Hammer, Thomas
Grueb, Matthias
Berk, Hüsnü
Gamulescu, Maria-Andreea
Source
Issue
Vol. 2020, Issue 2020 (31 Dec. 2020), pp.1-13, 13 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2020-10-06
Country of Publication
Egypt
No. of Pages
13
Main Subjects
Abstract EN
Aim.
The prospective, noninterventional OCEAN study assessed the safety of intravitreal ranibizumab injections for treatment of neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion under real-world conditions in Germany.
Methods.
Adults receiving ≥1 ranibizumab (0.5 mg) injections were recruited by 369 ophthalmologists and followed for 24 months.
Information on adverse events (AEs) was reported by the treating physician or detected by the data management team.
Collected information included observed AE, AE start and end date, intensity, causal relationship, outcome, severity, suspected drug, and actions taken.
Results.
2,687 AEs were reported for 1,176 of the 5,781 patients who had received a total of 32,621 injections: 27.4% nonserious AEs, 30.3% serious AEs, 27.3% nonserious adverse drug reactions (ADRs), and 15.0% serious ADRs.
Most patients reported no AEs (79.7%) or only 1 AE (10.3%).
AEs were most commonly reported in the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) Eye disorders (9.4% of patients) and General disorders and administration site conditions (5.8%).
The most frequent AEs by MedDRA preferred term (PT) were visual acuity reduced (3.5% of patients), intraocular pressure increased (2.5%), and drug ineffective (2.1%).
AEs occurred most frequently after 3 or 4 injections (1,129 of 2,687 AEs).
The proportion of AEs in the SOC Eye disorders decreased slightly with increasing number of injections, from 39.8% of events after 1 or 2 injections to 29.1% after 5 or more injections.
Rates of the most frequently reported PTs did not show any consistent increase with increasing number of injections.
A decrease in overall AE rates was observed over the study course.
Conclusions.
The results did not raise any new safety concerns for ranibizumab.
The findings allow conclusions to be drawn on how pharmacovigilance data can be collected even more effectively in real-world studies to facilitate discussion on benefit-risk ratio.
American Psychological Association (APA)
Ziemssen, Focke& Hammer, Thomas& Grueb, Matthias& Müller, Bettina& Berk, Hüsnü& Gamulescu, Maria-Andreea…[et al.]. 2020. Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial. Journal of Ophthalmology،Vol. 2020, no. 2020, pp.1-13.
https://search.emarefa.net/detail/BIM-1189781
Modern Language Association (MLA)
Ziemssen, Focke…[et al.]. Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial. Journal of Ophthalmology No. 2020 (2020), pp.1-13.
https://search.emarefa.net/detail/BIM-1189781
American Medical Association (AMA)
Ziemssen, Focke& Hammer, Thomas& Grueb, Matthias& Müller, Bettina& Berk, Hüsnü& Gamulescu, Maria-Andreea…[et al.]. Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial. Journal of Ophthalmology. 2020. Vol. 2020, no. 2020, pp.1-13.
https://search.emarefa.net/detail/BIM-1189781
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1189781