PMID- 33083052
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220417
IS  - 2090-004X (Print)
IS  - 2090-0058 (Electronic)
IS  - 2090-004X (Linking)
VI  - 2020
DP  - 2020
TI  - Reporting of Safety Events during Anti-VEGF Treatment: Pharmacovigilance in a 
      Noninterventional Trial.
PG  - 8652370
LID - 10.1155/2020/8652370 [doi]
LID - 8652370
AB  - 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.
CI  - Copyright (c) 2020 Focke Ziemssen et al.
FAU - Ziemssen, Focke
AU  - Ziemssen F
AUID- ORCID: 0000-0002-3873-0581
AD  - Centre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, 
      Germany.
FAU - Hammer, Thomas
AU  - Hammer T
AD  - Augenzentrum Halle, Dessauer Str. 194, 06118 Halle, Germany.
AD  - Universitatsklinik und Poliklinik fur Augenheilkunde der 
      Martin-Luther-Universitat Halle-Wittenberg, Ernst-Grube-Str. 40, 06112 Halle, 
      Germany.
FAU - Grueb, Matthias
AU  - Grueb M
AD  - Centre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, 
      Germany.
AD  - Augenarztpraxis Villa Im Lindengarten, Breisach, Germany.
FAU - Mueller, Bettina
AU  - Mueller B
AD  - Novartis Pharma GmbH, 90429 Nuremberg, Germany.
FAU - Berk, Husnu
AU  - Berk H
AD  - St. Elisabeth Klinik Hohenlind, Cologne, Germany.
FAU - Gamulescu, Maria-Andreea
AU  - Gamulescu MA
AD  - Universitatsaugenklinik Regensburg, Franz-Josef-Strauss Allee 11, 93051 
      Regensburg, Germany.
FAU - Voegeler, Jessica
AU  - Voegeler J
AD  - Novartis Pharma GmbH, 90429 Nuremberg, Germany.
FAU - Wachtlin, Joachim
AU  - Wachtlin J
AD  - Departement of Ophthalmology, Sankt-Gertrauden Krankenhaus, Paretzer Str. 12, 
      10713 Berlin, Germany.
AD  - MHB Medizinische Hochschule Brandenburg, Neuruppin, Germany.
FAU - Ocean Study Group
AU  - Ocean Study Group
AD  - Centre for Ophthalmology, Eberhard-Karls-University Tuebingen, 72076 Tuebingen, 
      Germany.
LA  - eng
PT  - Journal Article
DEP - 20201006
PL  - United States
TA  - J Ophthalmol
JT  - Journal of ophthalmology
JID - 101524199
PMC - PMC7558801
COIS- Focke Ziemssen received grants and personal fees from Biogen, Allergan, Alimera, 
      Bayer Healthcare, and Roche, grants from Clearside, and personal fees from 
      Boehringer Ingelheim, Novartis, Novo Nordisk, and MSD Sharp & Dohme. Thomas 
      Hammer received personal fees from Alcon, Bayer Healthcare, and Novartis and was 
      an advisory board member for Alcon. Matthias Grueb received grants from Novartis 
      and Bayer and personal fees from Novartis. Bettina Mueller and Jessica Voegeler 
      are Novartis employees. Husnu Berk declares no conflicts of interest outside the 
      OCEAN study participation fees. Maria-Andreea Gamulescu received personal fees 
      from Allergan and Novartis. Joachim Wachtlin received fees from Novartis, Bayer, 
      Alcon, and Allergan and was an advisory board member for Novartis, Bayer, and 
      Alcon.
EDAT- 2020/10/22 06:00
MHDA- 2020/10/22 06:01
PMCR- 2020/10/06
CRDT- 2020/10/21 06:02
PHST- 2020/03/26 00:00 [received]
PHST- 2020/07/09 00:00 [revised]
PHST- 2020/07/17 00:00 [accepted]
PHST- 2020/10/21 06:02 [entrez]
PHST- 2020/10/22 06:00 [pubmed]
PHST- 2020/10/22 06:01 [medline]
PHST- 2020/10/06 00:00 [pmc-release]
AID - 10.1155/2020/8652370 [doi]
PST - epublish
SO  - J Ophthalmol. 2020 Oct 6;2020:8652370. doi: 10.1155/2020/8652370. eCollection 
      2020.