PMID- 35301822
OWN - NLM
STAT- MEDLINE
DCOM- 20220420
LR  - 20220420
IS  - 2052-1707 (Electronic)
IS  - 2052-1707 (Linking)
VI  - 10
IP  - 2
DP  - 2022 Apr
TI  - Evaluation of cardiac parameters and other safety outcomes of brolucizumab 
      treatment in patients with neovascular age-related macular degeneration.
PG  - e00897
LID - 10.1002/prp2.897 [doi]
LID - e00897
AB  - This was a prospective, single-dose, single-arm, open-label, non-randomized, 
      multicenter clinical study to determine cardiovascular safety after a single 
      brolucizumab 6 mg intravitreal injection in neovascular age-related macular 
      degeneration patients (N = 14). Electrocardiogram (ECG) data were collected at 
      different time points using 12-lead Holter and standard ECG, and patients were 
      followed up to 8 days (end of study) for any signs of ocular and non-ocular 
      adverse events (AEs). No clinically meaningful changes were observed in cardiac 
      parameters. No patient had a >/=30 msec change from baseline in heart 
      rate-corrected QT using Fridericia's formula (QTcF), and no patient had a new 
      QTcF value of >/=450 msec between 20 and 24 h after treatment. No deaths or serious 
      AEs were reported during the study period. These results are in line with the 
      absence of new cardiovascular safety signal based on the ECG recordings collected 
      over the first year of the pivotal studies performed with brolucizumab in DME. 
      Trial Registration: ClinicalTrials.gov identifier: NCT03954626.
CI  - (c) 2022 The Authors. Pharmacology Research & Perspectives published by British 
      Pharmacological Society and American Society for Pharmacology and Experimental 
      Therapeutics and John Wiley & Sons Ltd.
FAU - Zakaria, Nadia
AU  - Zakaria N
AUID- ORCID: 0000-0003-4862-5491
AD  - Novartis Institutes for BioMedical Research, Translational Medicine, Cambridge, 
      Massachusetts, USA.
FAU - Guerard, Nicolas
AU  - Guerard N
AD  - Global Drug Development, Novartis Pharma AG, Basel, Switzerland.
FAU - Emanuelli, Andres
AU  - Emanuelli A
AD  - Emanuelli Research and Development Center, Arecibo, Puerto Rico, USA.
FAU - Dugel, Pravin
AU  - Dugel P
AD  - IVERIC bio, New York, New York, USA.
FAU - Watts, Jen
AU  - Watts J
AD  - Novartis Pharmaceuticals Corporation, East Hannover, New Jersey, USA.
FAU - Liew, Melissa
AU  - Liew M
AD  - Novartis Institutes for BioMedical Research, Translational Medicine, Cambridge, 
      Massachusetts, USA.
FAU - Gekkieva, Margarita
AU  - Gekkieva M
AD  - Global Drug Development, Novartis Pharma AG, Basel, Switzerland.
FAU - Hinder, Markus
AU  - Hinder M
AUID- ORCID: 0000-0003-2293-8342
AD  - Novartis Institutes for BioMedical Research, Translational Medicine, Basel, 
      Switzerland.
LA  - eng
SI  - ClinicalTrials.gov/NCT03954626
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pharmacol Res Perspect
JT  - Pharmacology research & perspectives
JID - 101626369
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - XSZ53G39H5 (brolucizumab)
SB  - IM
MH  - *Angiogenesis Inhibitors/adverse effects
MH  - Antibodies, Monoclonal, Humanized/adverse effects
MH  - Humans
MH  - *Macular Degeneration/drug therapy
MH  - Prospective Studies
PMC - PMC8931501
OTO - NOTNLM
OT  - anti-VEGF
OT  - brolucizumab
OT  - cardiovascular
OT  - intravitreal
OT  - nAMD
EDAT- 2022/03/19 06:00
MHDA- 2022/04/21 06:00
PMCR- 2022/03/18
CRDT- 2022/03/18 05:45
PHST- 2021/03/23 00:00 [received]
PHST- 2021/10/23 00:00 [accepted]
PHST- 2022/03/18 05:45 [entrez]
PHST- 2022/03/19 06:00 [pubmed]
PHST- 2022/04/21 06:00 [medline]
PHST- 2022/03/18 00:00 [pmc-release]
AID - PRP2897 [pii]
AID - 10.1002/prp2.897 [doi]
PST - ppublish
SO  - Pharmacol Res Perspect. 2022 Apr;10(2):e00897. doi: 10.1002/prp2.897.