Comparison between intravitreal brolucizumab and aflibercept in the treatment-naive central involved diabetic macular edema: One-year real-life case series

Abstract

Purpose

To evaluate the effectiveness and safety of intravitreal brolucizumab (IVB) and intravitreal aflibercept (IVA) injections in the management of naive central involved diabetic macular edema (CIDME).

Methods

This study included 45 treatment-naive eyes with CIDME. A complete ophthalmic examination, including BCVA and SD-OCT was performed. Patients were randomized to (IVB) or (IVA) groups. All participants received a loading phase of three consecutive intravitreal injections, then followed by a personalized treat and extend (T&E) regimen.

Results

At 12-month follow-up, the mean numbers of injections in IVA and IVB groups were 7.25  ±  0.53 and 6.3  ±  0.45, respectively (P < 0.0001). The IVA group showed a significant increase of the mean BCVA from 0.66  ±  0.15 logMAR (50.9  ±  7.7 letters) to 0.41  ±  0.19 logMAR (63.7  ±  10.8 letters). Mean CFT decreased significantly from 441.2  ±  35.7 μm to 281.3  ±  18.4 μm. The IVB group showed a significant increase of mean BCVA from 0.65  ±  0.16 logMAR (52.1  ±  7.9 letters) to 0.39  ±  0.17 logMAR (65.3  ±  8.7 letters). Mean CFT decreased significantly from 437.2  ±  41.9 μm to 275.5  ±  21.7 μm.

No significant difference between both groups in terms of the vision improvement and the reduction of CFT was reported, whereas a statistical difference was observed in terms of intravitreal injections (IVI) numbers. No ocular complications were reported.

Conclusions

This case series highlights the effectiveness of both brolucizumab and aflibercept in the treatment of CIDME with a lower frequency of injection in brolucizumab group lowering the burden of IVI in this cohort.