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) >300 μm on spectral domain optical coherence tomography (SD-OCT) despite at least 4 intravitreal bevacizumab injections in the prior 6 months were recruited for this prospective, single-armed, single centre, open-label clinical trial. Five loading doses of intravitreal aflibercept were administered every 4 weeks until week 16, at which point the treatment interval was extended to 8 weeks. All participants were reviewed every 4 weeks. 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 ± 23.8 months. Mean CMT reduced from 417 ± 91 μm at baseline to 380 ± 102 μm at 24 weeks (mean reduction 37 μm, p < 0.01). Mean BCVA improved from 67.8 ± 10.3 letters at baseline to 71.0 ± 10.1 letters at 24 weeks (mean 3.2 letter gain, p < 0.01). Eyes improving by ≥5 letters at 4 weeks following the first injection had improved vision outcomes at 24 weeks (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 24 weeks of follow up.
Clinical trial registration