Department of Experimental Medicine, Retina Unit, University of Rome Tor Vergata, Viale Oxford, Rome, Italy.
Laboratory of Biometry, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
Transl Vis Sci Technol. 2024 Jul 1;13(7):17. doi: 10.1167/tvst.13.7.17.
The purpose of this study was to evaluate the efficacy and safety of bevacizumab-awwb in the off-label treatment of neovascular age-related macular degeneration (n-AMD) and diabetic macular edema (DME).
All patients with n-AMD and DME treated in the maintenance phase according to the "treat and extend" strategy, who underwent forced drug substitution from bevacizumab to bevacizumab-awwb from October 2022 to April 2023 at the Tor Vergata Polyclinic in Rome, were evaluated in a retrospective study. The primary outcome was changes in central retinal thickness (CRT) over time following drug substitution. The secondary outcomes were variations in drug durability, best corrected visual acuity (BCVA) and retinal fluid, and the incidence of drug-related local and systemic serious adverse events.
Of 80 eyes of 76 patients with n-AMD and 55 eyes of 44 patients with DME included, before and after drug substitution, the average CRT did not statistically differ; the proportion of patients within time intervals of q8, q12, and q16 was not different; and the mean BCVA remained constant. Of a cumulative 3496 bevacizumab-awwb treatments (2154 for patients with n-AMD and 1342 for patients with DME), no local severe complications were detected. Out of a total of 544 patients (342 affected by n-AMD and 202 affected by DME), no serious adverse events were reported.
In our cohort of patients with n-AMD and DME in the maintenance phase, bevacizumab-awwb seems to represent a viable and cost-effective intravitreal therapy with comparable efficacy and safety to the originator.
This study provides a preliminary assessment of the efficacy and safety of intravitreal bevacizumab-awwb, which is widely used off-label in retinal vascular diseases.
本研究旨在评估贝伐单抗-awwb 在未经批准的治疗新生血管性年龄相关性黄斑变性（nAMD）和糖尿病黄斑水肿（DME）中的疗效和安全性。
在罗马 Tor Vergata 综合医院，对 2022 年 10 月至 2023 年 4 月期间，根据“治疗和扩展”策略在维持阶段接受治疗的所有 nAMD 和 DME 患者进行回顾性研究，这些患者接受了强制药物替换，从贝伐单抗替换为贝伐单抗-awwb。主要结局是药物替换后中央视网膜厚度（CRT）随时间的变化。次要结局是药物耐久性、最佳矫正视力（BCVA）和视网膜液的变化，以及药物相关局部和全身严重不良事件的发生率。
纳入的 76 例 nAMD 患者的 80 只眼和 44 例 DME 患者的 55 只眼中，药物替换前后平均 CRT 无统计学差异；处于 q8、q12 和 q16 时间间隔内的患者比例无差异；平均 BCVA 保持不变。在总计 3496 次贝伐单抗-awwb 治疗（2154 次用于 nAMD 患者，1342 次用于 DME 患者）中，未发现局部严重并发症。在总共 544 例患者（342 例患有 nAMD，202 例患有 DME）中，未报告严重不良事件。
在我们的 nAMD 和 DME 维持阶段患者队列中，贝伐单抗-awwb 似乎是一种可行且具有成本效益的玻璃体内治疗方法，其疗效和安全性与原研药物相当。
“Purpose: The purpose of this study was to evaluate the efficacy and safety of bevacizumab-awwb in the off-label treatment of neovascular age-related macular degeneration (n-AMD) and diabetic macular edema (DME).”翻译为“目的：本研究旨在评估贝伐单抗-awwb 在未经批准的治疗新生血管性年龄相关性黄斑变性（nAMD）和糖尿病黄斑水肿（DME）中的疗效和安全性。”
“METHODS: All patients with n-AMD and DME treated in the maintenance phase according to the “treat and extend” strategy, who underwent forced drug substitution from bevacizumab to bevacizumab-awwb from October 2022 to April 2023 at the Tor Vergata Polyclinic in Rome, were evaluated in a retrospective study.”翻译为“方法：在罗马 Tor Vergata 综合医院，对 2022 年 10 月至 2023 年 4 月期间，根据“治疗和扩展”策略在维持阶段接受治疗的所有 nAMD 和 DME 患者进行回顾性研究，这些患者接受了强制药物替换，从贝伐单抗替换为贝伐单抗-awwb。”
“CONCLUSIONS: In our cohort of patients with n-AMD and DME in the maintenance phase, bevacizumab-awwb seems to represent a viable and cost-effective intravitreal therapy with comparable efficacy and safety to the originator.”翻译为“结论：在我们的 nAMD 和 DME 维持阶段患者队列中，贝伐单抗-awwb 似乎是一种可行且具有成本效益的玻璃体内治疗方法，其疗效和安全性与原研药物相当。”
