Outcomes similar for aflibercept alone vs. bevacizumab first in center-involved DME
NEW YORK — There was no significant difference in visual outcomes at 2 years in eyes treated with aflibercept monotherapy compared with eyes treated with bevacizumab first before switching to aflibercept, according to a study.
At the American Society of Retina Specialists annual meeting, Chirag D. Jhaveri, MD, FASRS, presented the results of a randomized multicenter clinical trial that aimed to assess the efficacy of aflibercept monotherapy in eyes with center-involved diabetic macular edema compared with bevacizumab followed by aflibercept, if needed.
“Insurance companies, due to cost differences, are increasingly requiring us to use step therapy, where we are required to use bevacizumab off label first before having the opportunity to use other on-label medications such as aflibercept,” Jhaveri said. “We, however, do not know if this step therapy regimen has any long-term compromises to visual acuity in patients with DME and 20/50 vision or worse. Therefore, [DRCR Retina Network] Protocol AC was designed to help answer this question.”
Jhaveri and colleagues assessed 312 eyes of adults aged 18 years or older with center-involved DME, visual acuity ranging from 20/50 to 20/320, and no history of anti-VEGF treatment within 12 months prior or any other DME treatment within 4 months. The mean change in visual acuity over 2 years for both treatment options was assessed as well as changes to retinal thickness, diabetic retinopathy severity and presence of center-involved DME.
Eyes assigned to bevacizumab were switched to aflibercept at 12 weeks if prespecified criteria for suboptimal response were met, including persistent center-involved DME, no improvement in visual acuity letter score and central subfield thickness not improved by 10% or more over the previous two visits.
Seventy percent of eyes in the bevacizumab group were switched to aflibercept by 2 years. At this time, 73% of eyes treated with aflibercept monotherapy had a visual acuity of 20/40 or better compared with 74% of eyes treated with bevacizumab first. Additionally, 60% of eyes treated with aflibercept monotherapy and 55% treated with bevacizumab first experienced resolution of center-involved DME at 2 years.
Jhaveri said that these results reinforce the efficacy of initiating therapy with bevacizumab and switching to aflibercept.
“There is no overall difference in the mean change in vision over a 2-year period, whether administering aflibercept monotherapy or giving bevacizumab at first and switching to aflibercept based on prespecified criteria, and there was no difference in retinal thickness,” he said. “Rescue treatment with aflibercept mitigated the average visual anatomical differences that arose by initiating bevacizumab compared to aflibercept. These results, however, can only be generalized in patients who were receiving this specific therapy and regimen and switch criteria. Initiating treatment may have significant cost reductions for the health care system.”
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Jhaveri C, et al. Aflibercept monotherapy vs initial bevacizumab followed by aflibercept if needed for treatment of center-involved diabetic macular edema. Presented at: American Society of Retina Specialists annual meeting; July 13-16, 2022; New York.
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