Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial
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 ranibi...
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doaj-33f61bdfa5ae4da2b6c629aeb78ec9422020-11-25T02:25:45ZengHindawi LimitedJournal of Ophthalmology2090-004X2090-00582020-01-01202010.1155/2020/86523708652370Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional TrialFocke Ziemssen0Thomas Hammer1Matthias Grueb2Bettina Mueller3Hüsnü Berk4Maria-Andreea Gamulescu5Jessica Voegeler6Joachim Wachtlin7OCEAN Study Group8Centre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, GermanyAugenzentrum Halle, Dessauer Str. 194, 06118 Halle, GermanyCentre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, GermanyNovartis Pharma GmbH, 90429 Nuremberg, GermanySt. Elisabeth Klinik Hohenlind, Cologne, GermanyUniversitätsaugenklinik Regensburg, Franz-Josef-Strauss Allee 11, 93051 Regensburg, GermanyNovartis Pharma GmbH, 90429 Nuremberg, GermanyDepartement of Ophthalmology, Sankt-Gertrauden Krankenhaus, Paretzer Str. 12, 10713 Berlin, GermanyCentre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, GermanyAim. 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.http://dx.doi.org/10.1155/2020/8652370 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Focke Ziemssen Thomas Hammer Matthias Grueb Bettina Mueller Hüsnü Berk Maria-Andreea Gamulescu Jessica Voegeler Joachim Wachtlin OCEAN Study Group |
spellingShingle |
Focke Ziemssen Thomas Hammer Matthias Grueb Bettina Mueller Hüsnü Berk Maria-Andreea Gamulescu Jessica Voegeler Joachim Wachtlin OCEAN Study Group Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial Journal of Ophthalmology |
author_facet |
Focke Ziemssen Thomas Hammer Matthias Grueb Bettina Mueller Hüsnü Berk Maria-Andreea Gamulescu Jessica Voegeler Joachim Wachtlin OCEAN Study Group |
author_sort |
Focke Ziemssen |
title |
Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial |
title_short |
Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial |
title_full |
Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial |
title_fullStr |
Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial |
title_full_unstemmed |
Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a Noninterventional Trial |
title_sort |
reporting of safety events during anti-vegf treatment: pharmacovigilance in a noninterventional trial |
publisher |
Hindawi Limited |
series |
Journal of Ophthalmology |
issn |
2090-004X 2090-0058 |
publishDate |
2020-01-01 |
description |
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. |
url |
http://dx.doi.org/10.1155/2020/8652370 |
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