Rübsam Anne, Hössl Leopold, Rau Saskia, Böker Alexander, Zeitz Oliver, Joussen Antonia M
Department of Ophthalmology, Charité-Universitätsmedizin Berlin, 13353 Berlin, Germany.
Berlin Institute of Health at Charité-Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany.
J Clin Med. 2024 Mar 21;13(6):1819. doi: 10.3390/jcm13061819.
: To report on the outcome of intravitreal brolucizumab compared to aflibercept in patients with diabetic macular edema (DME). : Prospective, observational, study in 35 eyes of 24 patients with a loading dose of five injections of 6 mg brolucizumab every 6 weeks (q6w, treatment-naïve eyes) or a minimum of two injections of brolucizumab q6w after the switch (recalcitrant DME eyes), followed by a treat and extend (T&E) regimen. The results were compared with 40 eyes of 31 DME patients who were treated with aflibercept. The data were obtained from the Berlin Macula Registry. The primary outcome measure was the change in best-corrected visual acuity (BCVA) at week 36. Secondary outcome measures were the change in central retinal thickness (CRT) and the treatment intervals until week 36. : BCVA increased significantly in treatment-naïve DME eyes treated with either brolucizumab (+0.12 logMAR, +6.4 letters, = 0.03) or aflibercept (+0.19 logMAR, +9.5 letters, = 0.001). In recalcitrant DME eyes, BCVA also increased significantly after switching to brolucizumab (+0.1 logMAR, +5 letters, = 0.006) or aflibercept (+0.11 logMAR, +5.5 letters, = 0.02). All treatment-naïve and recalcitrant DME eyes had a significant decrease in CRT after treatment with brolucizumab ( = 0.001 and < 0.001) or aflibercept ( = 0.0002 and = 0.03). At week 36, the mean treatment interval for brolucizumab was 11.3 weeks, while for aflibercept, it was 6.5 weeks for treatment-naïve eyes and 9.3 weeks vs. 5.3 weeks for pretreated eyes. : In routine clinical practice, patients with treatment-naïve and recalcitrant DME showed a favorable response to brolucizumab and aflibercept therapy, with a reduced injection frequency after brolucizumab treatment.
报告玻璃体内注射布罗芦izumab与阿柏西普治疗糖尿病性黄斑水肿(DME)患者的疗效。:对24例患者的35只眼进行前瞻性观察研究,初治眼每6周注射5次6mg布罗芦izumab作为负荷剂量,或转换治疗后每6周至少注射2次布罗芦izumab(难治性DME眼),随后采用治疗并延长(T&E)方案。将结果与31例接受阿柏西普治疗的DME患者的40只眼进行比较。数据来自柏林黄斑登记处。主要结局指标是36周时最佳矫正视力(BCVA)的变化。次要结局指标是中心视网膜厚度(CRT)的变化以及至36周的治疗间隔。:初治DME眼接受布罗芦izumab(+0.12 logMAR,+6.4字母,P = 0.03)或阿柏西普(+0.19 logMAR,+9.5字母,P = 0.001)治疗后BCVA显著提高。在难治性DME眼中,转换为布罗芦izumab(+0.1 logMAR,+5字母,P = 0.006)或阿柏西普(+0.11 logMAR,+5.5字母,P = 0.02)治疗后BCVA也显著提高。所有初治和难治性DME眼在接受布罗芦izumab(P = 0.001和P < 0.001)或阿柏西普(P = 0.0002和P = 0.03)治疗后CRT均显著降低。在36周时,布罗芦izumab的平均治疗间隔为11.3周,而阿柏西普在初治眼中为6.5周,在预处理眼中为9.3周对5.