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Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere®) in patients with neovascular age‑related macular degeneration

  • Authors:
    • Daniel A. Benisek
    • Julio Manzitti
    • Daniel Scorsetti
    • Andres M. Rousselot Ascarza
    • Amalia A. Ascarza
    • Diego Gomez Rancaño
    • Romina Quercia
    • Matias Ramirez Gismondi
    • Mateo A. Carpio Total
    • María L. Scorsetti
    • Eduardo Spitzer
    • Carola Lombas
    • Matías Deprati
    • María Ines Penna
    • Francisco Fernández
    • Marcelo A. Tinelli
  • View Affiliations / Copyright

    Affiliations: Consultorios Oftalmológicos Benisek‑Ascarza, Ciudad Autónoma de Buenos Aires, C1115ABB Buenos Aires, Argentina, Consultorio Oftalmológico Julio Manzitti, Ciudad Autonóma de Buenos Aires, C1124AAG Buenos Aires, Argentina, Instituto Scorsetti, Ciudad Autónoma de Buenos Aires, C1120AAC Buenos Aires, Argentina, Clinical Research Department, Laboratorio Elea‑Phoenix S.A., Los Polvorines, B1613AUE Buenos Aires, Argentina, Health Department, Laboratorio Elea‑Phoenix S.A., Los Polvorines, B1613AUE Buenos Aires, Argentina, Pharmacovigilance Department Laboratorio Elea‑Phoenix S.A., Los Polvorines, B1613AUE Buenos Aires, Argentina
    Copyright: © Benisek et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
  • Article Number: 162
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    Published online on: October 9, 2020
       https://doi.org/10.3892/etm.2020.9291
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Abstract

The present study was an open‑label, prospective, uncontrolled and multicenter clinical trial to investigate the safety and effectiveness of bevacizumab (Lumiere®) administered by the intravitreal route for the treatment of neovascular age‑related macular degeneration (nAMD). A total of 22 patients without previous treatment with anti‑vascular endothelial growth factor were recruited. Monthly therapy with 1.25 mg intravitreal bevacizumab was applied. Adverse events (AE), visual acuity (VA) and central retinal thickness (CRT) were assessed at baseline, day 1 and day 28 after each injection. A total of 87 AEs were reported; most of them were not serious (96.6%), expected (65.5%) and occurred after the third injection (56.3%). The most frequent AE was ‘conjunctival hemorrhage’ (29.9% of AEs), attributed to the injection procedure. Treatment was not suspended due to safety reasons in any case. After six months, a statistically significant gain of +8.2 (SD±8.8) letters and a CRT reduction of ‑75.50 µm (SD±120.3) were achieved with unilateral therapy. VA improvement and CRT reduction ​​were also achieved with bilateral therapy, although to a lesser extent. The results of the present study suggested that therapy with a minimum of 3 doses of bevacizumab over a 6‑month period was well tolerated and resulted in a sustained response regarding VA improvement and CRT reduction from the beginning of therapy compared with the baseline value. The study protocol was registered at clinicaltrials.gov (ref. no. NCT03668054).
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Benisek DA, Manzitti J, Scorsetti D, Rousselot Ascarza AM, Ascarza AA, Gomez Rancaño D, Quercia R, Ramirez Gismondi M, Carpio Total MA, Scorsetti ML, Scorsetti ML, et al: Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>&reg;</sup>) in patients with neovascular age‑related macular degeneration. Exp Ther Med 20: 162, 2020.
APA
Benisek, D.A., Manzitti, J., Scorsetti, D., Rousselot Ascarza, A.M., Ascarza, A.A., Gomez Rancaño, D. ... Tinelli, M.A. (2020). Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>&reg;</sup>) in patients with neovascular age‑related macular degeneration. Experimental and Therapeutic Medicine, 20, 162. https://doi.org/10.3892/etm.2020.9291
MLA
Benisek, D. A., Manzitti, J., Scorsetti, D., Rousselot Ascarza, A. M., Ascarza, A. A., Gomez Rancaño, D., Quercia, R., Ramirez Gismondi, M., Carpio Total, M. A., Scorsetti, M. L., Spitzer, E., Lombas, C., Deprati, M., Penna, M. I., Fernández, F., Tinelli, M. A."Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>&reg;</sup>) in patients with neovascular age‑related macular degeneration". Experimental and Therapeutic Medicine 20.6 (2020): 162.
Chicago
Benisek, D. A., Manzitti, J., Scorsetti, D., Rousselot Ascarza, A. M., Ascarza, A. A., Gomez Rancaño, D., Quercia, R., Ramirez Gismondi, M., Carpio Total, M. A., Scorsetti, M. L., Spitzer, E., Lombas, C., Deprati, M., Penna, M. I., Fernández, F., Tinelli, M. A."Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>&reg;</sup>) in patients with neovascular age‑related macular degeneration". Experimental and Therapeutic Medicine 20, no. 6 (2020): 162. https://doi.org/10.3892/etm.2020.9291
Copy and paste a formatted citation
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Spandidos Publications style
Benisek DA, Manzitti J, Scorsetti D, Rousselot Ascarza AM, Ascarza AA, Gomez Rancaño D, Quercia R, Ramirez Gismondi M, Carpio Total MA, Scorsetti ML, Scorsetti ML, et al: Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>&reg;</sup>) in patients with neovascular age‑related macular degeneration. Exp Ther Med 20: 162, 2020.
APA
Benisek, D.A., Manzitti, J., Scorsetti, D., Rousselot Ascarza, A.M., Ascarza, A.A., Gomez Rancaño, D. ... Tinelli, M.A. (2020). Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>&reg;</sup>) in patients with neovascular age‑related macular degeneration. Experimental and Therapeutic Medicine, 20, 162. https://doi.org/10.3892/etm.2020.9291
MLA
Benisek, D. A., Manzitti, J., Scorsetti, D., Rousselot Ascarza, A. M., Ascarza, A. A., Gomez Rancaño, D., Quercia, R., Ramirez Gismondi, M., Carpio Total, M. A., Scorsetti, M. L., Spitzer, E., Lombas, C., Deprati, M., Penna, M. I., Fernández, F., Tinelli, M. A."Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>&reg;</sup>) in patients with neovascular age‑related macular degeneration". Experimental and Therapeutic Medicine 20.6 (2020): 162.
Chicago
Benisek, D. A., Manzitti, J., Scorsetti, D., Rousselot Ascarza, A. M., Ascarza, A. A., Gomez Rancaño, D., Quercia, R., Ramirez Gismondi, M., Carpio Total, M. A., Scorsetti, M. L., Spitzer, E., Lombas, C., Deprati, M., Penna, M. I., Fernández, F., Tinelli, M. A."Safety and clinical effectiveness of intravitreal administration of bevacizumab (Lumiere<sup>&reg;</sup>) in patients with neovascular age‑related macular degeneration". Experimental and Therapeutic Medicine 20, no. 6 (2020): 162. https://doi.org/10.3892/etm.2020.9291
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