Assessing intravitreal anti-VEGF drug safety using real-world data: methodological challenges in observational research

Scondotto, G; Crisafulli, Salvatore; Antonazzo, Ippazio Cosimo; Virgili, Gianni; Trifirò, Gianluca; Sultana, Janet

doi:10.1080/14740338.2021.1957829

Cited by 5 publications

(3 citation statements)

References 35 publications

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“…17,18 In the current clinical studies, it is controversial whether the anti-VEGF treatment of ocular diseases increases cardio-cerebrovascular events and presents a different risk in different anti-VEGF drugs. 19 Despite the conflicting results of the current studies, 20 many of them have demonstrated the need for vigilance against cardio-cerebrovascular adverse events associated with anti-VEGF therapy for ocular disease. This study further described the cardio-cerebrovascular risk of ranibizumab, bevacizumab, and aflibercept based on FAERS for providing a valuable complement evidence of drug safety.…”

Section: Discussionmentioning

confidence: 96%

“…Still, their pharmacokinetic and pharmacological properties suggest that the anti‐VEGF effect in the systemic circulation may carry a potential risk of serious cardio‐cerebrovascular–related adverse events 17,18 . In the current clinical studies, it is controversial whether the anti‐VEGF treatment of ocular diseases increases cardio‐cerebrovascular events and presents a different risk in different anti‐VEGF drugs 19 . Despite the conflicting results of the current studies, 20 many of them have demonstrated the need for vigilance against cardio‐cerebrovascular adverse events associated with anti‐VEGF therapy for ocular disease.…”

Section: Discussionmentioning

confidence: 99%

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Cardiovascular and Cerebrovascular Safety of Ranibizumab, Bevacizumab, and Aflibercept in Ocular Diseases: An Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Zeng

Xiao

et al. 2023

The Journal of Clinical Pharma

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The cardiovascular and cerebrovascular safety of ranibizumab, bevacizumab, and aflibercept for ocular diseases is unclear. This study aimed to evaluate and compare the cardiovascular and cerebrovascular safety in patients receiving ranibizumab, bevacizumab, and aflibercept for ocular disease. A crosssectional study was conducted from 2017 (Q1) to 2021 (Q4) in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. The outcomes of interest were central nervous system vascular disorders, ischemic heart disease, hypertension, pulmonary hypertension, torsade de pointes/QT prolongation, embolic and thrombotic events, cardiac arrhythmias, cardiac failure, and cardiomyopathy. Data mining was performed by a disproportional method with a compression, using compressed reporting odds ratios (sRORs) with 95% confidence intervals (CIs) to measure signals. The results showed 1462 cardiovascular and cerebrovascular events associated with aflibercept, 834 with ranibizumab, and 150 with bevacizumab. Ranibizumab, bevacizumab, and aflibercept were linked to central nervous system vascular disorders (

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Section: Discussionmentioning

confidence: 96%

Section: Discussionmentioning

confidence: 99%

Cardiovascular and Cerebrovascular Safety of Ranibizumab, Bevacizumab, and Aflibercept in Ocular Diseases: An Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Zeng

Xiao

et al. 2023

The Journal of Clinical Pharma

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“…15 In addition, CBC, a recombinant fusion protein with high affinity to all VEGF isoforms and placental growth factor (PIGF), was developed and approved in China in 2013 for the treatment of wet AMD, with definite clinical efficacy. 16 Although many studies [17][18][19] have emphasized that intravitreal injection of anti-VEGF drugs has a good effect on the treatment of CNV, it is an invasive procedure that suffers from some injection-related complications, such as intraocular infection, retinal detachment, and cataracts, which could lead to severe visual impairment. [20][21][22] In addition, the therapy requires multiple repeated injections, and the drugs are expensive, placing a financial strain on patients.…”

Section: Introductionmentioning

confidence: 99%

Topical Application of Cell-Penetrating Peptide Modified Anti-VEGF Drug Alleviated Choroidal Neovascularization in Mice

Hu,

Cai,

et al. 2024

IJN

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Background Age-related macular degeneration (AMD) stands as the foremost cause of irreversible central vision impairment, marked by choroidal neovascularization (CNV). The prevailing clinical approach to AMD treatment relies on intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs. However, this method is encumbered by diverse complications, prompting exploration of non-invasive alternatives such as ocular administration via eye drops for anti-VEGF therapy. Methods Two complexes, 5-FITC-CPP-Ranibizumab (5-FCR) and 5-FITC-CPP-Conbercept (5-FCC), were synthesized by incorporating the anti-VEGF drugs Ranibizumab (RBZ) or Conbercept (CBC) with cell-penetrating peptide (CPP). Circular dichroism spectrum (CD) facilitated complexes characterization. Eye drops was utilized to address laser-induced CNV in mice. Fluorescein fundus angiography (FFA) observe the CNV lesion, while FITC-dextran and IB4 dual fluorescent staining, along with hematoxylin-eosin (HE) staining, assessed in lesion size. Tissue immunofluorescence examined CD31 and VEGF expression in choroidal/retinal pigment epithelial (RPE) tissues. Biocompatibility and biosafety of 5-FCR and 5-FCC was evaluated through histological examination of various organs or cell experiments. Results Both 5-FCR and 5-FCC exhibited favorable biocompatibility and safety profiles. VEGF-induced migration of Human umbilical vein endothelial cells (HUVECs) significantly decreased post-5-FCR/5-FCC treatment. Additionally, both complexes suppressed VEGF-induced tube formation in HUVECs. FFA results revealed a significant improvement in retinal exudation in mice. Histological examination unveiled the lesion areas in the 5-FCR and 5-FCC groups showed a significant reduction compared to the control group. Similar outcomes were observed in histological sections of the RPE-choroid-sclera flat mounts. Conclusion In this study, utilizing the properties of CPP and two anti-VEGF drugs, we successfully synthesized two complexes, 5-FCR and 5-FCC, through a straightforward approach. Effectively delivering the anti-VEGF drugs to the target area in a non-invasive manner, suppressing the progression of laser-induced CNV. This offers a novel approach for the treatment of wet AMD.

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Effect Modification by Indication to the Risks of Major Thromboembolic Adverse Events in Patients Receiving Intravitreal Anti-Vascular Endothelial Growth Factor Treatment: A Population-Based Retrospective Cohort Study

et al. 2022

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Assessing intravitreal anti-VEGF drug safety using real-world data: methodological challenges in observational research

Cited by 5 publications

References 35 publications

Cardiovascular and Cerebrovascular Safety of Ranibizumab, Bevacizumab, and Aflibercept in Ocular Diseases: An Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Cardiovascular and Cerebrovascular Safety of Ranibizumab, Bevacizumab, and Aflibercept in Ocular Diseases: An Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Topical Application of Cell-Penetrating Peptide Modified Anti-VEGF Drug Alleviated Choroidal Neovascularization in Mice

Effect Modification by Indication to the Risks of Major Thromboembolic Adverse Events in Patients Receiving Intravitreal Anti-Vascular Endothelial Growth Factor Treatment: A Population-Based Retrospective Cohort Study

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