Chakraborty Debdulal, Sharma Ashish, Mondal Soumen, Sheth Jay, Sinha Tushar Kanti, Boral Subhendu, Mukherjee Angshuman, Bhattacharya Ranabir, Maitra Ritobroto
Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.
Dept of Retina Services, Lotus Eye Hospital and Institute, Coimbatore, TN, India.
Am J Ophthalmol Case Rep. 2024 Aug 23;36:102152. doi: 10.1016/j.ajoc.2024.102152. eCollection 2024 Dec.
To compare the safety and efficacy of aflibercept with brolucizumab for recalcitrant diabetic macular edema (DME).
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.
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.
比较阿柏西普与布罗卢单抗治疗顽固性糖尿病性黄斑水肿（DME）的安全性和有效性。
在第52周时，接受布罗卢单抗治疗的眼睛（P = 0.527）和接受阿柏西普治疗的眼睛（P = 0.393）均未观察到显著的视力改善。布罗卢单抗治疗后52周时，中心凹视网膜厚度（CMT）显著降低（P = 0.012），而阿柏西普治疗组则未降低（P = 0.284）。两组患者视网膜内液（IRF）和视网膜下液（SRF）的比例均显著降低。在52周的时间里，布罗卢单抗的平均注射次数（3.93[±1.28]）显著低于阿柏西普（4.75[±1.62]）（P = 0.037）。在第52周时，接受布罗卢单抗治疗的眼睛中有76.67%达到黄斑完全干燥（CMT<300μm且无SRF和IRF），而接受阿柏西普治疗的眼睛这一比例为50%（P = 0.036）。结膜下出血是该研究中观察到的唯一不良事件（P = 0.701）；未报告其他全身或眼部不良事件，如眼内炎症。
BRADIR研究表明，在治疗顽固性DME时，布罗卢单抗在视力和解剖学结局方面可能优于阿柏西普，且在52周的观察期内注射频率更低。
