Clinical and Electrophysiological Evaluation After Intravitreal Ziv-Aflibercept for Exudative Age-Related Macular Degeneration

Dias, João Rafael de Oliveira; Andrade, Gabriel Costa de; Kniggendorf, Vinícius; Novais, Eduardo Amorim; Maia, André; Meyer, Carsten H.; Watanabe, Sung Eun Song; Farah, Michel Eid; Rodrigues, Eduardo B

doi:10.1097/iae.0000000000001385

Cited by 20 publications

(16 citation statements)

References 27 publications

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“…The cost of these anti-VEGF therapeutics varies, limiting their use [ 25 ]. Ziv-aflibercept is a recombinant fusion protein that is reported to improve visual acuity in patients with neovascular AMD and to be a cheaper alternative to the same molecule aflibercept [ 26 , 27 ]. The frequent need for repeated intravitreal anti-VEGF injections is an important factor affecting treatment costs.…”

Section: Resultsmentioning

confidence: 99%

Retinal and choroidal angiogenesis: a review of new targets

et al. 2017

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Retinal and choroidal neovascularization are a major cause of significant visual impairment, worldwide. Understanding the various factors involved in the accompanying physiopathology is vital for development of novel treatments, and most important, for preserving patient vision. The intraocular use of anti-vascular endothelial growth factor therapeutics has improved management of the retinal and choroidal neovascularization but some patients do not respond, suggesting other vascular mediators may also contribute to ocular angiogenesis. Several recent studies examined possible new targets for future anti-angiogenic therapies. Potential targets of retinal and choroidal neovascularization therapy include members of the platelet-derived growth factor family, vascular endothelial growth factor sub-family, epidermal growth factor family, fibroblast growth factor family, transforming growth factor-β superfamily (TGF-β1, activins, follistatin and bone morphogenetic proteins), angiopoietin-like family, galectins family, integrin superfamily, as well as pigment epithelium derived factor, hepatocyte growth factor, angiopoietins, endothelins, hypoxia-inducible factors, insulin-like growth factors, cytokines, matrix metalloproteinases and their inhibitors and glycosylation proteins. This review highlights current antiangiogenic therapies under development, and discusses future retinal and choroidal pro- and anti-angiogenic targets as wells as the importance of developing of new drugs.Electronic supplementary materialThe online version of this article (doi:10.1186/s40942-017-0084-9) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

Retinal and choroidal angiogenesis: a review of new targets

et al. 2017

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“…En concentraciones terapéuticas se observó una disminución del potencial de membrana mitocondrial en ZA y bevacizumab 10 . Siendo este último ampliamente usado y probado su eficacia y seguridad clínica en ensayos clínicos aleatorizados [11][12][13] . Además, De Oliveira Dias, et al 13 realizaron un estudio a 6 meses donde no encontraron cambios en el electrorretinograma (ERG) multifocal basal comparado con los realizados a las semanas 4, 13 y 26 en pacientes con DMREh a dosis de 1.25 mg 14 .…”

Section: Discussionunclassified

“…Siendo este último ampliamente usado y probado su eficacia y seguridad clínica en ensayos clínicos aleatorizados [11][12][13] . Además, De Oliveira Dias, et al 13 realizaron un estudio a 6 meses donde no encontraron cambios en el electrorretinograma (ERG) multifocal basal comparado con los realizados a las semanas 4, 13 y 26 en pacientes con DMREh a dosis de 1.25 mg 14 . A su vez, Chhablani, et al 16 realizaron estudios donde usaron ZA a dosis de 1.25 mg y 2 mg, donde no encontraron efectos adversos ni datos de toxicidad en el ERG a 30 días de la aplicación comparado con el ERG basal [15][16][17] .…”

Section: Discussionunclassified

“…En nuestro estudio a corto plazo, la mayor debilidad es la falta de estudios de electrofisiología para evaluar la posible toxicidad a corto plazo de ZA, aunque los estudios publicados no encontraron cambios en el ERG [13][14][15][16] . El ZA parece ser un medicamento seguro y eficiente para el manejo del edema macular, independientemente de la causa, además de su costo accesible.…”

Section: Conclusionesunclassified

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Seguridad del uso intravítreo de 2 mg de ziv-aflibercept a corto plazo en diferentes patologías retinianas

Meza-Anguiano¹,

Romo-García²,

Gutiérrez-Ruiz³

et al. 2019

Revista Mexicana De Oftalmología

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Evaluar la seguridad y efectividad del uso de ziv-aflibercept (ZA) en diferentes enfermedades retinianas a dosis de 2 mg. Métodos: Estudio de un único grupo, abierto, prospectivo; se administró una dosis de 2 mg (0,08 ml) de ZA siguiendo los protocolos de la unidad hospitalaria con anestesia tópica. Se consideraron efectos adversos: aumento de presión intraocular >3 mmHg de la basal, desprendimiento de retina, hemorragia vítrea, endoftalmitis, vasculitis o necrosis retiniana, progresión de la catarata, uveitis anterior y posterior. Resultados: Se incluyeron 91 ojos de 55 pacientes, 50% hombres, edad media 64.26 ± 11.86 años, una media de 1.68 ± 0.91 inyecciones, grosor foveal central inicial (GFC) 390.91 ± 162.01 micras comparado con un GFC final de 319.02 ± 104.67 micras (p = 0.000), y una agudeza visual mejor corregida (AVMC) en logMAR de la 0.86 ± 0.49 comparada con una AVMC final de 0.75 ± 0.48 (p = 0.000). No se reportaron efectos adversos en ninguna de las 149 administraciones de ZA. Conclusiones: ZA es un medicamento seguro y eficiente para el tratamiento del edema macular, independientemente de la causa, además de su costo accesible. Se necesitan estudios a largo plazo para evaluar la efectividad de este medicamento en comparación con los fármacos ya aprobados para el uso intravítreo.

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“…2) over 4 years and maintained a visual acuity of 20/25. Electroretinographic (ERG) abnormalities (changes in implicit times, awave and b-wave amplitudes, or b/a ratios) have not been noted 1 month after single IVZ injections in most patients with nAMD (Chhablani et al 2016;de Oliveira Dias et al 2017) but increased rod and cone amplitudes were measured at 1 month in an 89year-old man with nAMD (de Oliveira Dias et al 2014). Significant changes in the b/a ratio were not found in 21 eyes of 20 patients with nAMD ( 14), polypoidal choroidal vasculopathy (3), myopia (2) and idiopathic juxtafoveal telangiectasia (2) 1 month after single injections of 2 mg IVZ (Chhablani et al 2017).…”

Section: Human Retinal Toxicity Assessmentmentioning

confidence: 99%

Ziv‐aflibercept: A cost‐effective, off‐label, highly potent antagonist of vascular endothelial growth factor

Mansour

Stewart

Farah

et al. 2019

Acta Ophthalmologica

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Ziv-aflibercept (Zaltrap â ), a recombinant fusion protein that binds diffusible vascular endothelial growth factor (VEGF), is approved for the treatment of metastatic colorectal carcinoma. Its molecular structure is the same as aflibercept (Eylea â ), thus making it an attractive option for the off-label treatment of chorioretinal vascular conditions. Ziv-aflibercept is distributed in 4 and 8 ml vials for intravenous use, and its cost after compounding is similar to bevacizumab. Studies with retinal pigment epithelium cytotoxicity, animal histologic sections and electroretinography have demonstrated its safety, and mathematical modelling combined with over four dozen clinical publications from different ophthalmic centres throughout the world attest to its efficacy. No appreciable differences in visual or anatomic outcomes between 1.25 mg (0.05 ml) and 2.5 mg (1.0 ml) doses have been noted. The long duration of action combined with the low cost make ziv-aflibercept an attractive anti-VEGF treatment option, especially in low-and middle-income countries where its popularity is increasing.

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Clinical and Electrophysiological Evaluation After Intravitreal Ziv-Aflibercept for Exudative Age-Related Macular Degeneration

Cited by 20 publications

References 27 publications

Retinal and choroidal angiogenesis: a review of new targets

Retinal and choroidal angiogenesis: a review of new targets

Seguridad del uso intravítreo de 2 mg de ziv-aflibercept a corto plazo en diferentes patologías retinianas

Ziv‐aflibercept: A cost‐effective, off‐label, highly potent antagonist of vascular endothelial growth factor

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