ArticleOphthalmology and therapy2023
Trends in the Cumulative Post-Marketing Reporting Rates of Retinal Vasculitis and/or Retinal Vascular Occlusion and Associated Vision Loss with Brolucizumab.
Article in Ophthalmology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 11 citations in OpenAlex.
- Aflibercept and Brolucizumab in Diabetic Macular Edema: A Focused Review of Efficacy, Safety, and Clinical Considerations.Biomedicines · 2026Review
- Inflammation and Vasculitis Related to Brolucizumab.Journal of clinical medicine · 2024Article
- Real-World Safety Outcomes with Brolucizumab in Neovascular Age-Related Macular Degeneration: Findings from the IRIS® Registry.Ophthalmology and therapy · 2024Article
- Functional Outcomes of Brolucizumab-Induced Intraocular Inflammation Involving the Posterior Segment-A Meta-Analysis and Systematic Review.Journal of clinical medicine · 2023Review
- Efficacy and Safety of Brolucizumab, Aflibercept, and Ranibizumab for the Treatment of Patients with Visual Impairment Due to Diabetic Macular Oedema: A Systematic Review and Network Meta-Analysis.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023Article
- Pharmacokinetic and Pharmacodynamic Rationale for Extending VEGF Inhibition Increasing Intravitreal Aflibercept Dose.Pharmaceutics · 2023Article
Corrections and comments
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Authors and funding
3 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionBrolucizumab, a low-molecular weight anti-vascular endothelial growth factor, was approved in the USA in October 2019 for the treatment of neovascular age-related macular degeneration. Following post-marketing reports of vasculitis, including retinal occlusive vasculitis, a safety signal of retinal vasculitis (RV) and/or retinal vascular occlusion (RO) that may result in severe vision loss was confirmed. This brief communication reviews the trends in the cumulative reporting rates of RV and/or RO and associated vision loss from May 2020 to September 2022.
methodsThis is a descriptive analysis of the cumulative post-marketing reporting rates of RV and/or RO cases, and associated vision loss included in the Novartis safety database between May 2020 and September 2022, utilizing an enhanced pharmacovigilance program.
resultsThe RV-alone rates demonstrated an upward trend, rising to 5.1 events per 10,000 injections by October 2020 and subsequently remained stable until July 2021. Thereafter, the rate for RV-alone events increased modestly until October 2021 and then remained stable until September 2022. The RO-alone rates increased to 3.4 events per 10,000 injections by January 2021 and subsequently remained stable until September 2022. The combined reports of RV and RO showed an upward trend until December 2020 (7.5 events per 10,000 injections), followed by a plateau until September 2021 and then a downward trend until September 2022. Vision loss associated with RV and/or RO progressively increased until December 2020 (5.9 events per 10,000 injections) followed by a declining trend until September 2022 to the most recent reporting rate of 4.1 events per 10,000 injections.
conclusionThe cumulative post-marketing reporting rates of vision loss associated with RV and/or RO, following brolucizumab treatment, have shown a declining trend after an initial rise in the reporting rates immediately after identification of the safety signal.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.