Safety of 5914 intravitreal ziv-aflibercept injections

Br J Ophthalmol. 2019 Jun;103(6):805-810. doi: 10.1136/bjophthalmol-2018-312453. Epub 2018 Aug 11.

Abstract

Purpose: To analyse the pooled safety data of intravitreal ziv-aflibercept (IVZ) therapy for various retinal conditions.

Methods: This was a retrospective, observational study which included patients from 14 participating centres who received IVZ. The medical records of patients who received IVZ from March 2015 through October 2017 were evaluated. Patient demographics and ocular details were compiled. Ocular and systemic adverse events that occurred within 1 month of IVZ injections were recorded and defined as either procedure-related or drug-related.

Results: A total of 1704 eyes of 1562 patients received 5914 IVZ injections (mean±SD: 3.73±3.94) during a period of 2.5 years. The age of patients was 60.6±12.8 years (mean±SD) and included diverse chorioretinal pathologies. Both ocular (one case of endophthalmitis, three cases of intraocular inflammation, and one case each of conjunctival thinning/necrosis and scleral nodule) and systemic adverse events (two cases of myocardial infarction, one case of stroke and two deaths) were infrequent.

Conclusion: This constitutes the largest pooled safety report on IVZ use and includes patients from 14 centres distributed across the globe. It shows that IVZ has an acceptable ocular and systemic safety profile with incidences of adverse events similar to those of other vascular endothelial growth factor inhibitory drugs. The analysis supports the continued use of IVZ in various retinal disorders.

Keywords: diabetic macular edema (DME); intravitreal ziv-aflibercept (IVZ); neovascular age related macular degeneration (n-AMD); retinal venous occlusion (RVO); ziv-aflibercept.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Humans
  • Intravitreal Injections / statistics & numerical data
  • Male
  • Middle Aged
  • Receptors, Vascular Endothelial Growth Factor / administration & dosage*
  • Receptors, Vascular Endothelial Growth Factor / antagonists & inhibitors
  • Recombinant Fusion Proteins / administration & dosage*
  • Retina / pathology*
  • Retinal Diseases / diagnosis
  • Retinal Diseases / drug therapy*
  • Retrospective Studies
  • Time Factors
  • Tomography, Optical Coherence
  • Treatment Outcome
  • Visual Acuity*

Substances

  • Recombinant Fusion Proteins
  • aflibercept
  • Receptors, Vascular Endothelial Growth Factor