Brolucizumab versus aflibercept for recalcitrant diabetic macular edema in Indian real-world scenario - The BRADIR study.

PURPOSE

To compare the safety and efficacy of aflibercept with brolucizumab for recalcitrant diabetic macular edema (DME).

OBSERVATIONS

At week 52, no significant visual improvement was noted in the eyes treated with either brolucizumab ( = 0.527) or aflibercept ( = 0.393). The CMT decreased significantly after brolucizumab therapy ( = 0.012), but not with aflibercept ( = 0.284) at 52 weeks. The proportion of patients with IRF and SRF reduced significantly in both arms. The mean number of brolucizumab injections was significantly lower (3.93[±1.28]) than aflibercept (4.75[±1.62]) ( = 0.037) over the 52 weeks. At 52 weeks, 76.67 % of eyes treated with brolucizumab attained full macular dryness (CMT<300 μm with absence of SRF and IRF) compared to 50 % of eyes treated with aflibercept ( = 0.036). Subconjunctival hemorrhage was the only adverse event observed in the study ( = 0.701); no other systemic or ocular adverse events, such as intraocular inflammation, were reported.

CONCLUSION AND IMPORTANCE

The BRADIR study suggests that brolucizumab might have an edge over aflibercept in visual and anatomical outcomes that lasted 52 weeks with reduced injection frequency in case of recalcitrant DME.