TY - JOUR
T1 - Imaging Features of Retinal Vasculitis and/or Retinal Vascular Occlusion after Brolucizumab Treatment in the Postmarketing Setting
AU - Grewal, Dilraj S.
AU - Wykoff, Charles C.
AU - D'Souza, Divya
AU - Jehl, Valentine
AU - Alecu, Iulian
AU - Jaffe, Glenn J.
N1 - Funding Information:
The authors thank Samriddhi Buxy Sinha, PhD and Helene Karcher, PhD (both Novartis Pharma AG, Basel, Switzerland) for the visual acuity data analysis. Medical writing support, under the guidance of the authors, was provided by Susan Simpson, PhD ( Novartis Ireland Ltd.), in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ). Medical writing support was funded by Novartis Pharma AG.
Funding Information:
Financial support was provided by Novartis Pharma AG (Basel, Switzerland). The sponsor or funding organization participated in the design of the study; management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript.The authors thank Samriddhi Buxy Sinha, PhD and Helene Karcher, PhD (both Novartis Pharma AG, Basel, Switzerland) for the visual acuity data analysis. Medical writing support, under the guidance of the authors, was provided by Susan Simpson, PhD (Novartis Ireland Ltd.), in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). Medical writing support was funded by Novartis Pharma AG. HUMAN SUBJECTS: This study complied with the tenets of the Declaration of Helsinki and is based on a retrospective analysis of deidentified data obtained as part of routine clinical practice. As the patient data was spontaneously reported to the pharmacovigilance data system, consent was considered implicit and specific institutional review board (IRB) approval was not required. Duke Reading Centre has IRB approval to conduct research on all deidentified ocular images submitted to the reading center (Duke IRB Pro00046442). Additional consent was obtained from the reporting physicians for the utilization of images for publication purposes. Only those images for which both the patients and reporting physicians granted consent have been included in this publication. Obtained funding: Grewal, Jaffe
Publisher Copyright:
© 2023 American Academy of Ophthalmology
PY - 2024/1/1
Y1 - 2024/1/1
N2 - Purpose: The aim of this analysis was to characterize the spectrum of inflammatory changes arising from brolucizumab use in routine clinical practice. Design: Retrospective analysis of fluorescein angiography (FA), fundus photography (FP) and OCT images taken at the time of adverse event. Subjects: Brolucizumab-treated patients with neovascular age-related macular degeneration with retinal vasculitis (RV) and/or retinal vascular occlusion (RO) reported to Novartis Patient Safety between February 2020 and January 2021. Methods: Ocular images were reviewed by an external reading center using predefined grading lists for FA, FP, and OCT. Main Outcome Measures: Classification of images, the most common imaging features of RV and/or RO by each imaging modality, and the anatomical location of the adverse event in relation to the macula. Results: Gradable images (N = 475; 222 eyes; 198 patients) were classified as RV only (n = 72); RO only (n = 9), RV + RO (n = 63); posterior segment intraocular inflammation (n = 31); or none by imaging (n = 47). Of the 144 eyes with RV and/or RO, the most common imaging features were vascular leakage on FA, perivascular sheathing on FP, and hyperreflective dots in the vitreous humor on OCT. Retinal vascular occlusion was mainly branched and arterial, affecting multiple vessels. Conclusions: Although no distinct inflammatory phenotype pathognomonic to brolucizumab-related inflammation was identified, this study increases our understanding of the spectrum of posterior segment inflammatory changes that may occur in brolucizumab-treated neovascular age-related macular degeneration patients, highlighting the potential value of widefield retinal imaging and angiography to detect these inflammatory adverse events. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
AB - Purpose: The aim of this analysis was to characterize the spectrum of inflammatory changes arising from brolucizumab use in routine clinical practice. Design: Retrospective analysis of fluorescein angiography (FA), fundus photography (FP) and OCT images taken at the time of adverse event. Subjects: Brolucizumab-treated patients with neovascular age-related macular degeneration with retinal vasculitis (RV) and/or retinal vascular occlusion (RO) reported to Novartis Patient Safety between February 2020 and January 2021. Methods: Ocular images were reviewed by an external reading center using predefined grading lists for FA, FP, and OCT. Main Outcome Measures: Classification of images, the most common imaging features of RV and/or RO by each imaging modality, and the anatomical location of the adverse event in relation to the macula. Results: Gradable images (N = 475; 222 eyes; 198 patients) were classified as RV only (n = 72); RO only (n = 9), RV + RO (n = 63); posterior segment intraocular inflammation (n = 31); or none by imaging (n = 47). Of the 144 eyes with RV and/or RO, the most common imaging features were vascular leakage on FA, perivascular sheathing on FP, and hyperreflective dots in the vitreous humor on OCT. Retinal vascular occlusion was mainly branched and arterial, affecting multiple vessels. Conclusions: Although no distinct inflammatory phenotype pathognomonic to brolucizumab-related inflammation was identified, this study increases our understanding of the spectrum of posterior segment inflammatory changes that may occur in brolucizumab-treated neovascular age-related macular degeneration patients, highlighting the potential value of widefield retinal imaging and angiography to detect these inflammatory adverse events. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
KW - Brolucizumab
KW - Imaging
KW - Intraocular inflammation
KW - Retinal vascular occlusion
KW - Retinal vasculitis
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U2 - 10.1016/j.xops.2023.100361
DO - 10.1016/j.xops.2023.100361
M3 - Article
C2 - 37869023
AN - SCOPUS:85174031958
SN - 2666-9145
VL - 4
SP - 100361
JO - Ophthalmology Science
JF - Ophthalmology Science
IS - 1
M1 - 100361
ER -