Navegando por Palavras-chave "Ziv-Aflibercepte"

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    Injeções intravítreas de Ziv-aflibercepte: segurança in vitro e in vivo
    (Universidade Federal de São Paulo (UNIFESP), 2019-04-25) Andrade, Gabriel Costa De [UNIFESP]; Rodrigues, Eduardo Buchele [UNIFESP]; http://lattes.cnpq.br/4226917385383502; http://lattes.cnpq.br/6358895255996576; Universidade Federal de São Paulo (UNIFESP)
    Objective: To access the cytotoxicity of two fusion proteins with vascular endothelial growth anti-factor action (ziv-aflibercept and aflibercept) on retinal pigment epithelium (RPE) cells and Muller-Glia cells in culture by assessing cell viability post drug exposure. To study the safety of intravitreal injections of ziv-aflibercept in patients with diabetic macular edema (DME). To review the literature on the different fusion proteins used for the treatment of retinal diseases. Methods: In the first study, primary human RPE cells (pRPE) and Muller-Glia cells (MIO-M1) were exposed to the clinical standardized concentrations of ziv-aflibercept (25 mg/mL) and aflibercept (40 mg/mL). The study was applied to measure pRPE and MIO-M1 viability by a tetrazolium dyereduction assay (XTT). In the second study, seven patients with diabetic macular edema (DME) underwent intravitreal injections of 0.05 mL of ziv-aflibercept (25 mg/ mL) with a four-week interval. The safety of intravitreous ziv-aflibercept was assessed by the results of full-field ERG, and the efficacy was determined by the best corrected visual acuity (BCVA) measurements and central retinal thickness (CRT) in the OCT. The safety and efficacy parameters were evaluated at 24 and 48 weeks after initiation of ziv-aflibercept treatment. In addition to commercially available aflibercept, two other drugs, ziv-aflibercept and conbercept, have been studied in antiangiogenic treatment of ocular diseases. In this scenario, a critical review of the currently available data regarding fusion proteins in ophthalmic diseases resulted in the third study. Results: Cell viability of both pRPE and MIO-M1 presented no significant changes after exposure of ziv-aflibercept (25 mg/mL) and aflibercept (40 mg/mL). In the second study, the seven patients completed the 48 weeks follow-up. Intravitreous injections of ziv-aflibercept significantly improved the visual acuity and decreased the CRT in OCT throughout the treatment. No signs of retinal toxicity were seen in full-field ERGs and no systemic adverse events were reported. One case of epiretinal membrane, one case of subconjunctival hemorrhage and three cases of ocular pain were reported after intravitreal injection of ziv-aflibercept. In the third study, the molecular characteristics and mechanism of action of aflibercept, ziv-aflibercept and conbercept were listed. Structurally these fusion proteins are very similar with binding to all isoforms of VEGF-A, VEGF-B and PIGF. Conbercept also has VEGF-C binding. Conclusions: At clinical doses, both ziv-aflibercept and aflibercept did not cause any significant reduction in cell viability in vitro. In the study performed in patients with DME, there were improvement of BCVA and decrease of CRT 24 and 48 weeks after treatment with intravitreal ziv-aflibercept, with no findings of retinal toxicity on full-field ERG after 24 and 48 weeks. According to the third study, there is evidence of safety and efficacy of aflibercept, ziv-aflibercept and conbercept in the treatment of retinal diseases such as exudative AMD, DME and macular edema secondary to venous occlusions.