Case Western Reserve University School of Medicine, Cleveland, Ohio; Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Genentech, Inc., South San Francisco, California.
Ophthalmol Retina. 2024 Nov;8(11):1074-1082. doi: 10.1016/j.oret.2024.05.017. Epub 2024 Jun 1.
To characterize anti-VEGF intravitreal therapy (IVT) patterns and long-term visual outcomes among patients with diabetic macular edema (DME) in routine clinical practice in the United States.
Retrospective analysis of the American Academy of Ophthalmology's IRIS® (Intelligent Research in Sight) Registry.
Treatment-naïve patients with DME (no previous IVT in the past 12 months) initiating anti-VEGF IVT from January 1, 2015, to March 31, 2021.
Baseline characteristics, treatment patterns, and long-term visual acuity (VA) outcomes were reported for up to 6 years of follow-up.
Outcomes included the annualized number of injections, change in VA, and anti-VEGF agents.
A total of 190 345 eyes met the inclusion criteria. After 1 year of anti-VEGF IVT initiation, eyes received a mean of 3.9 (±2.8) injections and gained +3.2 (±16.4) letters of vision. Of the 1236 eyes with year 6 data, eyes received a mean of 2.9 (±2.1) injections in year 6 and gained +0.5 (±19.7) letters from baseline. The number of injections decreased, and injection intervals increased year over year up to 6 years regardless of baseline VA initiation. The average injection interval was 10 weeks in year 1 and increased to 13.2 weeks in year 2 before plateauing in years 3 to 6 (12.6, 12.3, 12.2, and 12.3 weeks, respectively). Improvements in VA from baseline were greatest in eyes that received 5 or more injections each year. At the end of follow-up, eyes with good baseline vision (>20/25) lost vision, whereas those with worse baseline vision (<20/25) gained vision. Although 51.7% of patients with DME discontinued IVT after a mean of 6 months, 32.8% reinitiated anti-VEGF IVT. Worse VA outcomes were associated with patients of Hispanic ethnicity (-1.08; 95% confidence interval: -1.34, -0.83] compared with non-Hispanic), Medicaid insurance (-1.15; 95% confidence interval: -1.48, -0.81 compared with commercial), and older age (-0.06; 95% confidence interval: -0.07, -0.05] each additional year).
Patients with DME in routine clinical settings receive fewer injections than those in clinical trials and fewer than recommended per the label of US Food and Drug Administration-approved anti-VEGF IVT.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.
描述美国常规临床实践中患有糖尿病黄斑水肿（DME）患者的抗血管内皮生长因子玻璃体内治疗（IVT）模式和长期视力结局。
美国眼科学会的 IRIS®（智能研究中的视力）注册研究的回顾性分析。
2015 年 1 月 1 日至 2021 年 3 月 31 日期间，开始接受抗 VEGF IVT 的未经治疗的 DME（过去 12 个月内无先前 IVT）患者。
报告了长达 6 年的随访期间的基线特征、治疗模式和长期视力结局。
结局包括每年注射次数、视力变化和抗 VEGF 药物。
共纳入 190345 只眼。抗 VEGF IVT 起始后 1 年，平均每只眼接受 3.9（±2.8）次注射，视力提高了+3.2（±16.4）个字母。在有 6 年数据的 1236 只眼中，6 年时每只眼平均接受 2.9（±2.1）次注射，与基线相比视力提高了+0.5（±19.7）个字母。每年的注射次数减少，注射间隔逐年增加，最长可达 6 年，无论基线 VA 起始如何。第 1 年的平均注射间隔为 10 周，第 2 年增加到 13.2 周，然后在第 3 年至第 6 年稳定在 12.6、12.3、12.2 和 12.3 周（分别）。每年接受 5 次或更多注射的眼视力改善最大。在随访结束时，基线视力较好（>20/25）的眼视力下降，而基线视力较差（<20/25）的眼视力提高。尽管 DME 患者中有 51.7%在平均 6 个月后停止了 IVT，但 32.8%重新开始了抗 VEGF IVT。较差的 VA 结局与西班牙裔患者（-1.08；95%置信区间：-1.34，-0.83）相比，非西班牙裔患者（-1.15；95%置信区间：-1.48，-0.81）、医疗补助保险（-1.15；95%置信区间：-1.48，-0.81）和年龄较大（-0.06；95%置信区间：-0.07，-0.05）每增加 1 年相关。
在常规临床环境中接受治疗的 DME 患者接受的注射次数少于临床试验中的患者，也少于美国食品和药物管理局批准的抗 VEGF IVT 标签上推荐的注射次数。
在文章末尾的脚注和披露中可以找到专有或商业披露。
