Intravitreal Ziv-Aflibercept for Neovascular Age-Related Macular Degeneration

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

doi:10.1097/iae.0000000000002001

Cited by 14 publications

(16 citation statements)

References 22 publications

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“…Lens changes, intraocular inflammation and retinal abnormalities have not been observed on slit lamp biomicroscopy and spectral domain-optical coherence tomography after single zivaflibercept injections (Mansour et al 2015;de Oliveira Dias et al 2015;Chhablani et al 2016), after three injections (Baghi et al 2017;Mansour et al 2017a,b), after 1 year of therapy (de Andrade et al 2018;de Oliveira Dias et al 2019;Jabbarpoor Bonyadi et al 2018;Mansour et al 2017a,b) and after 3 years of therapy (Mansour et al 2018(Mansour et al , 2019a in patients with nAMD and DME. In the longest reported follow-up, a patient received 48 monthly IVZ injections (Fig.…”

Section: Human Retinal Toxicity Assessmentmentioning

confidence: 99%

“…The first reported human use of intravitreal ziv-aflibercept resulted in successful treatment of a patient with refractory neovascular age-related macular degeneration (nAMD) (de Oliveira Dias et al 2015) and this was soon followed by a pilot study of four patients with nAMD and two patients with diabetic macular oedema (DME) (Mansour et al 2015). Based on the encouraging results of this pilot study, several prospective short-term and long-term studies (Figs 2-5) with monthly injections (de Andrade et al 2018), treat-and-extend (Mansour et al 2019a) or pro re nata (Eldeeb et al 2017;de Oliveira Dias et al 2019) regimens have been performed in the following countries: Brazil (Andrade et al 2016;de Oliveira Dias et al 2016;de Oliveira Dias et al 2019); Egypt (Ashraf et al 2017a); India (Videkar et al 2015;Chhablani et al 2016Chhablani et al , 2017Yogi et al 2017); Iran (Baghi et al 2017, Jabbarpoor Bonyadi et al 2018HodjatJalali et al 2017); Lebanon (Mansour et al 2015); Mexico (Hernandez-Da Mota et al 2019); Switzerland (Doepfner et al 2018), Syria (Marashi 2016); and the United States (Aleman et al 2019…”

Section: Early Clinical Usementioning

confidence: 99%

“…Fourteen eyes of 14 patients with nAMD received three monthly IVZ injections followed by monthly pro re nata treatment for 1 year (de Oliveira Dias et al 2019). The mean visual acuity improved from 0.95 LogMAR (20/200) to 0.75 LogMar (20/125) and the mean CMT decreased from 478 to 304 lm.…”

Section: Clinical Studies In Namd Prospective Studiesmentioning

confidence: 99%

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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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Section: Human Retinal Toxicity Assessmentmentioning

confidence: 99%

Section: Early Clinical Usementioning

confidence: 99%

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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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“…However, vascular endothelial growth factor A (VEGF-A), a cytokine that promotes angiogenesis and vascular permeability, is one of the most important factors that promotes neovascularization (6). Active forms of VEGF-A have been identified in CNV (7)(8)(9). Anti-VEGF therapies are now becoming the focus of AMD treatment (7).…”

Section: Introductionmentioning

confidence: 99%

“…Anti-VEGF therapies are now becoming the focus of AMD treatment (7). Aflibercept and ranibizumab, two recombinant humanized monoclonal antibodies that inactivate VEGF-A, are novel therapies that help numerous AMD patients gain a sustainable vision (8). They were respectively approved in 2006 and 2011 by the US Food and Drug Administration for use in treating wet AMD (9,10).…”

Section: Introductionmentioning

confidence: 99%

Role of inflammatory factors in the effects of aflibercept or ranibizumab treatment for alleviating wet age‑associated macular degeneration

Yuan

2019

Exp Ther Med

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Aflibercept and ranibizumab are novel drugs for effectively treating wet age-associated macular degeneration (AMD). In the present study, the effect of aflibercept and ranibizumab on wet AMD was compared. A total of 80 AMD patients were intravitreously treated with aflibercept (2.0 mg/dose, 40 participants) or ranibizumab (0.3 mg/dose, 40 participants). The mean visual acuity and central subfield thickness (CTS) were determined at baseline and each follow-up visit (every 4 weeks). ELISA was used to detect the expression of transforming growth factor-β1 (TGF-β1), monocyte chemoattractant protein 1 (MCP-1) and interleukin 6 (IL-6). The primary outcome was the mean change in visual acuity letter score (VAS) and CTS at 1 year. The VAS was markedly improved by 13.1 in the aflibercept group and by 11.0 in the ranibizumab group. In a subgroup of patients with an initial VAS of <69, the mean improvement in the VAS was 17.7 in the aflibercept group and 13.2 in the ranibizumab group (P<0.01). The mean CTS was markedly decreased by 141 in the aflibercept group and by 134 in the ranibizumab group. In the subgroup of patients with an initial VAS of <69, the mean CTS was decreased by 171 in the aflibercept group and by 154 in the ranibizumab group (P<0.01). However, the change of VAS and CTS was similar between the ranibizumab and aflibercept groups when the initial VAS was ≥69. No significant differences in serious adverse events were identified between the aflibercept and ranibizumab groups. The levels of TGF-β1, IL-6 and MCP-1 were decreased by the aflibercept and ranibizumab treatments. The decrease in the levels of the inflammatory factors was more obvious in patients with an initial VAS of <69 in comparison with that in patients with an initial VAS of ≥69. Negative correlations between the levels of TGF-β1, MCP-1 and IL-6 and the mean change of VAS when patients were treated with aflibercept or ranibizumab were identified among all ages. Positive correlations between the levels of TGF-β1, MCP-1 and IL-6 and the mean change of CTS were observed when the initial VAS of the patients was <69. In conclusion, the efficacy of aflibercept in treating patients with AMD was better than that of ranibizumab when the initial VAS of the patients was <69. The inhibition of inflammatory factors may be a secondary effect of aflibercept and ranibizumab treatment. The present study provides a useful reference for the clinical treatment of wet AMD (Chinese Clinical Trial Registry no. ChiCTR1800017782).

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Clinical Trials Related to Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Ruamviboonsuk

Chotcomwonse

Nganthavee

et al. 2020

Choroidal Neovascularization

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Intravitreal Ziv-Aflibercept for Neovascular Age-Related Macular Degeneration

Abstract: The results suggested that intravitreal ziv-aflibercept might be safe and effective for treating neovascular age-related macular degeneration. More patients and a longer follow-up are needed to confirm the long-term outcomes of intravitreal ziv-aflibercept.

Cited by 14 publications

References 22 publications

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

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

Role of inflammatory factors in the effects of aflibercept or ranibizumab treatment for alleviating wet age‑associated macular degeneration

Clinical Trials Related to Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

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