目的:研究美国常规临床实践中糖尿病性黄斑水肿(DME)患者的抗血管内皮生长因子(VEGF)玻璃体腔治疗(IVT)模式和长期视力结果。
方法:回顾性分析美国眼科学会的视力智能研究(IRIS®)注册。;参与者:从2015年1月1日至2021年3月31日开始抗VEGFIVT的DME初治患者(过去12个月无IVT)。
方法:基线特征,治疗模式,报告了长达6年的长期视力(VA)结局.
方法:结果包括年度注射次数,VA的变化,和抗VEGF药物。
结果:共有190,345只眼符合纳入标准。抗VEGFIVT启动1年后,眼睛平均注射3.9(±2.8)次,视力增加3.2(±16.4)个字母。在6年数据的1236只眼睛中,在第6年,眼睛平均接受2.9(±2.1)次注射,从基线增加+0.5(±19.7)个字母.注射次数减少,和注射间隔逐年增加,直到6年,无论基线VA开始。第1年的平均注射间隔为10周,然后在第2年扩大到13.2,然后在第3-6年达到稳定(分别为12.6、12.3、12.2和12.3周)。在每年接受5次或更多次注射的眼睛中,VA从基线的改善最大。在后续行动结束时,基线视力良好(>20/25)的眼睛失去视力,而那些基线视力较差(<20/25)的人获得了视力。尽管51.7%的DME患者在平均6个月后停止IVT,32.8%重新开始抗VEGFIVT。更糟糕的VA结果与西班牙裔患者相关(与非西班牙裔相比,-1.08[-1.34,-0.83]),医疗补助保险(与商业保险相比,-1.15[-1.48,-0.81]),和年龄较大(-0.06[-0.07,-0.05]每增加一年)结论:常规临床环境中的DME患者接受的注射次数少于临床试验中的患者,并且少于FDA批准的抗VEGFIVT标签的推荐注射次数。
OBJECTIVE: 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.
METHODS: Retrospective analysis of the American Academy of Ophthalmology\'s IRIS® (Intelligent Research in Sight) Registry.
METHODS: 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.
METHODS: Baseline characteristics, treatment patterns, and long-term visual acuity (VA) outcomes were reported for up to 6 years of follow-up.
METHODS: Outcomes included the annualized number of injections, change in VA, and anti-VEGF agents.
RESULTS: 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).
CONCLUSIONS: 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.
BACKGROUND: Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.