PMID- 37391547
OWN - NLM
STAT- MEDLINE
DCOM- 20230705
LR  - 20231124
IS  - 2045-2322 (Electronic)
IS  - 2045-2322 (Linking)
VI  - 13
IP  - 1
DP  - 2023 Jun 30
TI  - Long-term surveillance provides real-world evidences of safety and effectiveness 
      in intravitreal aflibercept treatment for age-related macular degeneration.
PG  - 10597
LID - 10.1038/s41598-023-37584-1 [doi]
LID - 10597
AB  - This prospective, multicentre, postmarketing surveillance were conducted to 
      report on the long-term safety and effectiveness of intravitreal aflibercept 
      (IVT-AFL) treatment in clinical practice of Japanese patients with neovascular 
      age-related macular degeneration (nAMD) who newly initiated IVT-AFL treatment. 
      The primary outcomes were the incidence of adverse events (AEs) and of adverse 
      drug reactions (ADRs) over 36 months. Number of injections, timing of ADR 
      occurrence, and some effectiveness index were also summarised. A total of 3,872 
      patients received 7.2 +/- 5.8 (mean +/- standard deviation) injections, and AEs 
      occurred in 5.73% of patients. ADRs were reported in 2.76% of patients, with 
      ocular and nonocular ADRs in 2.07% and 0.72% of patients, respectively. Most 
      vitreo-retinal events developed within 6 months of initial IVT-AFL treatment, and 
      most instances of increased intraocular pressure and cerebral infarction 
      developed after 6 months of follow-up. Mean best-corrected visual acuity and 
      central retinal thickness were numerically better throughout the follow-up period 
      compared with baseline. These results indicated acceptable tolerability and 
      effectiveness of IVT-AFL treatment in patients with nAMD in clinical practice in 
      Japan. Information regarding the risk and the timing of ADRs is valuable for safe 
      and effective long-term treatment of patients with nAMD.Trial registration 
      number: NCT01756248.
CI  - (c) 2023. The Author(s).
FAU - Ozawa, Yoko
AU  - Ozawa Y
AUID- ORCID: 0000-0003-4797-5705
AD  - Department of Clinical Regenerative Medicine Eye Center, Fujita Medical 
      Innovation Center Tokyo, Fujita Health University School of Medicine, Tokyo, 
      Japan. ozawa@a5.keio.jp.
AD  - Department of Ophthalmology, St. Luke's International Hospital, Tokyo, Japan. 
      ozawa@a5.keio.jp.
AD  - Department of Ophthalmology, St. Luke's International University, Tokyo, Japan. 
      ozawa@a5.keio.jp.
AD  - Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan. 
      ozawa@a5.keio.jp.
FAU - Ohgami, Kazuhiro
AU  - Ohgami K
AD  - Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan.
FAU - Sasaki, Koji
AU  - Sasaki K
AD  - Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan.
FAU - Hirano, Kazufumi
AU  - Hirano K
AD  - Medical Affairs and Pharmacovigilance, Bayer Yakuhin, Ltd., Osaka, Japan.
FAU - Sunaya, Toshiyuki
AU  - Sunaya T
AD  - Research and Development Japan, Bayer Yakuhin, Ltd., Osaka, Japan.
LA  - eng
SI  - ClinicalTrials.gov/NCT01756248
PT  - Clinical Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230630
PL  - England
TA  - Sci Rep
JT  - Scientific reports
JID - 101563288
RN  - 15C2VL427D (aflibercept)
RN  - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor)
SB  - IM
MH  - Humans
MH  - *Drug-Related Side Effects and Adverse Reactions
MH  - *Macular Degeneration/drug therapy
MH  - Prospective Studies
MH  - Receptors, Vascular Endothelial Growth Factor
MH  - Retina
PMC - PMC10313657
COIS- This study was funded by Bayer Yakuhin, Ltd., Japan. YO has no conflict of 
      interest regarding this study. KO, KS, KH, and TS are employees of Bayer Yakuhin, 
      Ltd., Japan.
EDAT- 2023/07/01 11:41
MHDA- 2023/07/03 06:42
PMCR- 2023/06/30
CRDT- 2023/06/30 23:26
PHST- 2023/01/24 00:00 [received]
PHST- 2023/06/23 00:00 [accepted]
PHST- 2023/07/03 06:42 [medline]
PHST- 2023/07/01 11:41 [pubmed]
PHST- 2023/06/30 23:26 [entrez]
PHST- 2023/06/30 00:00 [pmc-release]
AID - 10.1038/s41598-023-37584-1 [pii]
AID - 37584 [pii]
AID - 10.1038/s41598-023-37584-1 [doi]
PST - epublish
SO  - Sci Rep. 2023 Jun 30;13(1):10597. doi: 10.1038/s41598-023-37584-1.