April 2014
Volume 55, Issue 13
Free
ARVO Annual Meeting Abstract  |   April 2014
Pre-clinical safety of intravitreal ziv-aflibercept
Author Affiliations & Notes
  • João Rafael de Oliveira Dias
    Ophthalmology, Federal University of São Paulo - UNIFESP / EPM, São Paulo, Brazil
  • Emmerson Badaró
    Ophthalmology, Federal University of São Paulo - UNIFESP / EPM, São Paulo, Brazil
  • Eduardo Novais
    Ophthalmology, Federal University of São Paulo - UNIFESP / EPM, São Paulo, Brazil
  • Daniel Colicchio
    Ophthalmology, Federal University of São Paulo - UNIFESP / EPM, São Paulo, Brazil
  • Mariana Matioli
    Ophthalmology, Suel Abujamra Institute, São Paulo, Brazil
  • Flavio E Hirai
    Ophthalmology, Federal University of São Paulo - UNIFESP / EPM, São Paulo, Brazil
  • Carsten Meyer
    Ophthalmology, Philipps-University Marburg, Marburg, Germany
  • Michel Farah
    Ophthalmology, Federal University of São Paulo - UNIFESP / EPM, São Paulo, Brazil
  • Eduardo Rodrigues
    Ophthalmology, Federal University of São Paulo - UNIFESP / EPM, São Paulo, Brazil
  • Footnotes
    Commercial Relationships João Dias, None; Emmerson Badaró, None; Eduardo Novais, None; Daniel Colicchio, None; Mariana Matioli, None; Flavio Hirai, None; Carsten Meyer, None; Michel Farah, None; Eduardo Rodrigues, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science April 2014, Vol.55, 1948. doi:
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      João Rafael de Oliveira Dias, Emmerson Badaró, Eduardo Novais, Daniel Colicchio, Mariana Matioli, Flavio E Hirai, Carsten Meyer, Michel Farah, Eduardo Rodrigues; Pre-clinical safety of intravitreal ziv-aflibercept. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1948.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: To describe the retinal toxicity of intravitreal ziv-aflibercept (Zaltrap®) in rabbits and to compare it with intravitreal aflibercept (Eylea®).

Methods: A total of 18 rabbits were enrolled in the study. Nine pigmented rabbits (chinchilla breed) were given intravitreal injection of 0.05 ml ziv-aflibercept (Zaltrap®, aflibercept 25 mg/ml) in the right eye and 9 pigmented rabbits were given 0.05 ml of aflibercept (Eylea®, aflibercept 40 mg/ml) in the right eye. In both groups, balanced salt solution served as control. Twelve rabbits were examined by fundoscopy and electroretinography at baseline and after 24 hours (3 animals of each group) or 7 days (3 animals of each group). Spectral domain optical coherence tomography was performed in both eyes of 6 rabbits (3 of each group) 7 days after the procedure. Serum and aqueous humor were collected before the injection and 24 hours or 7 days after, in order to analyze the osmolarity and pH of those fluids. Vitreous fluid was sampled from 4 rabbits, two of each group, at baseline and one week after the injection, for osmolarity and pH analysis.The animals were then killed and the eyes were assessed by light microscopy. Transmission electron microscopy was performed in 2 rabbits eyes (one of each group) one week after the injection.

Results: All eyes were negative for cataract, hemorrhage, retinal detachment, and intraocular opacities 24 hours or 7 days after Ziv-Aflibercept or Aflibercept injection, and OCT was negative for retinal atrophy or edema. At a volume of 0.05 ml of ziv-aflibercept, aflibercept or BSS, no statistically significant differences were recorded in ERG 24 hours or one week after the procedure. There were no statistical differences in blood osmolarity and aqueous pH and osmolarity at baseline and in follow-up. The histology of both experimental and control eyes showed no major anatomic signs of toxicity.

Conclusions: Ziv-aflibercept may be safe for the retina at a concentration of 25 mg/ml after intravitreal injection, and may be studied as an anti-VEGF alternative in human retinal diseases.

Keywords: 508 electrophysiology: non-clinical • 748 vascular endothelial growth factor • 763 vitreous  
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