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

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, 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

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).

Keywords: bevacizumab; central retinal thickness; intravitreal anti-VEGF therapy; neovascular age-related macular degeneration; visual acuity.

Copyright: © Benisek et al.

Figures

Figure 1
Figure 1
Flow chart of the movement of the patient in the present study. Visits 1 to 6 were performed at 1-month intervals.
Figure 2
Figure 2
Evolution of the total number of letters read (y-axis) as a measure of VA from baseline through to 6 months in patients who received (A) unilateral therapy (B) bilateral therapy (eye that was initially treated), (C) bilateral therapy (eye treated contralaterally) and (D) unilateral therapy (according to the total number of injections received). Results of baseline and follow-up assessments (visits 1 to 6) are presented and all visits are 1 month apart. A significant improvement in VA was observed for unilateral therapy (P**P<0.01; ***P<0.001 VA, visual acuity; V, visit.
Figure 3
Figure 3
Evolution of CRT measured by optical coherence tomography (y-axis) from baseline through to 6 months in patients who received (A) unilateral therapy, (B) bilateral therapy (eye that was initially treated), (C) bilateral therapy (eye treated contralaterally) and (D) unilateral therapy (according to the total number of injections received). Results of baseline and follow-up assessments (visits 1 to 6) are presented and all visits are 1 month apart. Pairwise comparisons for unilateral therapy showed significant differences from baseline at V3 (P=0.007) and V6 (P=0.027). The interpolation line connects the median value of CRT between the visits and the data points (small circles/plus symbols) correspond to outliers. *P<0.05; **P<0.01 CRT, central retinal thickness; V, visit; n.s., not significant.

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