Abstract

To evaluate the visual and anatomical outcomes following switching therapy from bevacizumab to aflibercept in patients with persistent diabetic macular edema (DME). Patients with DME and central macular thickness (CMT) >300μm on spectral domain optical coherence tomography (SD-OCT) despite at least 4 intravitreal bevacizumab injections in the prior 6months were recruited for this prospective, single-armed, single centre, open-label clinical trial. Five loading doses of intravitreal aflibercept were administered every 4weeks until week 16, at which point the treatment interval was extended to 8weeks. All participants were reviewed every 4weeks. At each visit, examination included best-corrected visual acuity (BCVA) measured with an Early Treatment of Diabetic Retinopathy Study chart and CMT measured with SD-OCT. Primary outcome measures were change in CMT and BCVA at week 24 compared with baseline. A total of 43 eyes from 43 patients were recruited for the study. At enrolment, study eyes had a mean ± standard deviation of 16.6 ± 11.5 previous intravitreal anti-VEGF injections over a period of 26.9 ± 23.8months. Mean CMT reduced from 417 ± 91μm at baseline to 380 ± 102μm at 24weeks (mean reduction 37μm, p < 0.01). Mean BCVA improved from 67.8 ± 10.3 letters at baseline to 71.0 ± 10.1 letters at 24weeks (mean 3.2 letter gain, p < 0.01). Eyes improving by ≥5 letters at 4weeks following the first injection had improved vision outcomes at 24weeks (6.8 ± 7.1 letters vs. 1.0 ± 4.7 letters, p < 0.01). Intravitreal aflibercept was effective in improving anatomical and visual outcomes among patients with incomplete response to intravitreal bevacizumab with 24weeks of follow up. ACTRN12614001307695.

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