Mishra Sanjay Kumar, Kumar Pradeep, Joshi Amrita, Saraf Aman, Awasthi Abhijeet, Dhar Supriya, M Khaleel, Kumar Atul, Rana Vipin, D Ravi
Army Hospital Research & Referral, Delhi Cantt, New Delhi, Delhi, 110010, India.
Command Hospital Eastern Command, Kolkata, India.
Int J Retina Vitreous. 2025 Jan 13;11(1):6. doi: 10.1186/s40942-025-00628-x.
Management of Diabetic Macular edema (DME) requires repeated injections. Therefore newer Anti-VEGFs like Brolucizumab with longer durability have been introduced. We compared two different dosages of Brolucizumab, 6.0 mg and 3.6 mg, for their safety & efficacy in treatment of DME, in treatment naïve patients over 52 weeks.
A prospective, pilot randomised controlled, single centre, double blinded, two arm comparative study was conducted between Dec 2022 to Apr 2024. The study recruited 82 patients of DME who were randomised into two groups of 41 patients each, one group to be treated with Brolucizumab 6.0 mg in 50 μL and the other to receive 3.6 mg in 30 μL. All patients received the first dose of Brolucizumab at 0 week and were then followed up at every 4 weeks for detailed ophthalmic and OCT macula examination. Those who met the pre-defined re-treatment criteria were re-injected with Brolucizumab, the dose being fixed for each group throughout the study. All patient receiving an injection were further followed up on Day 1, Day 7 and Day 28 to look for any adverse reactions. The efficacy parameters included change in best corrected visusal acuity (BCVA), contrast and central macular thickness (CMT) on Optical Coherence Tomography. The average number of injections recd in each group were also calculated.
The change in BCVA from baseline in 6.0 mg group was 0.54 LogMAR units and 3.6 mg group was 0.59 LogMAR units, which was not statistically significant. The reduction in CMT from baseline in 6.0 mg group was 133.2 µm (μ) and 3.6 mg group was 110.6 μ, which was not statistically significant. The improvement in contrast from baseline in 6.0 mg group was 0.74 and 3.6 mg group was 0.95, with p value of 0.0002. The re-injection interval was 14.21 weeks in 6.0 mg group and 15.56 weeks for 3.6 mg subgroup. The total number of adverse events in both groups were similar at 70 in 6.0 mg group and 47 in 3.6 mg group with only one grade 4 adverse event occurring in each group.
The results of present study show that the safety and efficacy of both doses of Brolucizumab, i.e. 6.0 mg and 3.6 mg, for treating diabetic macular edema is similar. Trial registration Study was registered with Clinical trials registry of India (CTRI ref no. CTRI/2023/06/054105), registered on 14 Nov 2022.
糖尿病性黄斑水肿（DME）的治疗需要反复注射。因此，已引入了耐久性更强的新型抗血管内皮生长因子（Anti-VEGFs），如布罗利尤单抗。我们比较了两种不同剂量的布罗利尤单抗，即6.0毫克和3.6毫克，在初治DME患者中治疗52周的安全性和有效性。
于2022年12月至2024年4月进行了一项前瞻性、试点随机对照、单中心、双盲、双臂比较研究。该研究招募了82例DME患者，随机分为两组，每组41例，一组接受50微升含6.0毫克布罗利尤单抗的治疗，另一组接受30微升含3.6毫克布罗利尤单抗的治疗。所有患者在第0周接受第一剂布罗利尤单抗，然后每4周进行随访，以进行详细的眼科和黄斑光学相干断层扫描（OCT）检查。符合预定义再治疗标准的患者接受布罗利尤单抗再次注射，整个研究期间每组的剂量固定。所有接受注射的患者在第1天、第7天和第28天进一步随访，以寻找任何不良反应。疗效参数包括最佳矫正视力（BCVA）的变化、对比度以及光学相干断层扫描上的中心黄斑厚度（CMT）。还计算了每组接受注射的平均次数。
6.0毫克组BCVA相对于基线的变化为0.54 LogMAR单位，3.6毫克组为0.59 LogMAR单位，差异无统计学意义。6.0毫克组CMT相对于基线的降低为133.2微米（μm），3.6毫克组为110.6μm，差异无统计学意义。6.0毫克组对比度相对于基线的改善为0.74，3.6毫克组为0.95，p值为0.0002。6.0毫克组的再次注射间隔为14.21周，3.6毫克亚组为15.56周。两组不良事件总数相似，6.0毫克组为70例，3.6毫克组为47例，每组仅发生1例4级不良事件。
本研究结果表明，两种剂量的布罗利尤单抗，即6.0毫克和
