Retina Consultants of Austin and Austin Research Center for Retina, Austin, Texas.
Jaeb Center for Health Research, Tampa, Florida.
Ophthalmology. 2024 Aug;131(8):967-974. doi: 10.1016/j.ophtha.2024.01.037. Epub 2024 Feb 8.
To identify factors for meeting prespecified criteria for switching from bevacizumab to aflibercept in eyes with center-involved diabetic macular edema (CI-DME) and moderate vision loss initially treated with bevacizumab in DRCR Retina Network protocol AC.
Post hoc analysis of data from a randomized clinical trial.
Two hundred seventy participants with one or both eyes harboring CI-DME with visual acuity (VA) letter score of 69 to 24 (Snellen equivalent, 20/50-20/320).
Eligible eyes were assigned to receive intravitreal aflibercept monotherapy (n = 158) or bevacizumab followed by aflibercept if prespecified criteria for switching were met between 12 weeks and 2 years (n = 154).
Meeting switching criteria: (1) at any time, (2) at 12 weeks, and (3) after 12 weeks. Associations between meeting the criteria for switching and factors measured at baseline and 12 weeks were evaluated in univariable analyses. Stepwise procedures were used to select variables for multivariable models.
In the group receiving bevacizumab first, older participants showed a higher risk of meeting the switching criteria at any time, with a hazard ratio (HR) for a 10-year increase in age of 1.32 (95% confidence interval [CI], 1.11-1.58). Male participants or eyes with worse baseline VA were more likely to switch at 12 weeks (for male vs. female: odds ratio [OR], 4.84 [95% CI, 1.32-17.81]; 5-letter lower baseline VA: OR, 1.30 [95% CI, 1.03-1.63]). Worse 12-week central subfield thickness (CST; 10-μm greater: HR, 1.06 [95% CI, 1.04-1.07]) was associated with increased risk of switching after 12 weeks. The mean ± standard deviation improvement in visual acuity after completing the switch to aflibercept was 3.7 ± 4.9 letters compared with the day of switching.
The identified factors can be used to refine expectations regarding the likelihood that an eye will meet protocol criteria to switch to aflibercept when treatment is initiated with bevacizumab. Older patients are more likely to be switched. At 12 weeks, thicker CST was predictive of eyes most likely to be switched in the future.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
确定符合预设标准从贝伐单抗转换为阿柏西普的因素，这些标准用于治疗 DRCR 视网膜网络协议 AC 中初始接受贝伐单抗治疗的中心性糖尿病黄斑水肿（CI-DME）和中度视力丧失的眼。
随机临床试验的事后分析。
270 名参与者的一只或两只眼患有 CI-DME，视力（VA）字母评分在 69 到 24 之间（Snellen 等价物，20/50-20/320）。
符合条件的眼睛被分配接受玻璃体内阿柏西普单药治疗（n=158）或贝伐单抗治疗，如果在 12 周至 2 年内符合转换标准，则接受贝伐单抗联合阿柏西普治疗（n=154）。
符合转换标准：（1）任何时间，（2）12 周时，（3）12 周后。在单变量分析中评估了符合转换标准与基线和 12 周时测量的因素之间的关系。使用逐步程序为多变量模型选择变量。
在接受贝伐单抗治疗的组中，年龄较大的患者在任何时候都有更高的符合转换标准的风险，年龄每增加 10 岁，风险比（HR）为 1.32（95%置信区间 [CI]，1.11-1.58）。男性参与者或基线 VA 较差的眼在 12 周时更有可能转换（与女性相比：比值比 [OR]，4.84 [95% CI，1.32-17.81]；基线 VA 低 5 个字母：OR，1.30 [95% CI，1.03-1.63]）。12 周时中央视网膜神经纤维层厚度（CST）恶化（增加 10μm：HR，1.06 [95% CI，1.04-1.07]）与 12 周后转换风险增加相关。完成从贝伐单抗转换为阿柏西普后的视力平均改善为 3.7±4.9 个字母，与转换日相比。
所确定的因素可用于改进对开始接受贝伐单抗治疗时符合协议标准转换为阿柏西普的眼的可能性的预期。年龄较大的患者更有可能被转换。在 12 周时，较厚的 CST 预示着未来最有可能被转换的眼睛。
本文末尾的脚注和披露中可能包含专有或商业披露。
