糖尿病黄斑水肿的长期治疗模式：IRIS® 登记处长达 6 年的随访。

IF 4.4 Q1 OPHTHALMOLOGY

Ophthalmology. Retina Pub Date : 2024-11-01 DOI:10.1016/j.oret.2024.05.017

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引用次数: 0

摘要

目的描述美国常规临床实践中糖尿病黄斑水肿（DME）患者的抗血管内皮生长因子（VEGF）玻璃体内治疗（IVT）模式和长期视觉疗效：设计：美国眼科学会视力智能研究（IRIS®）注册中心的回顾性分析；参与者：未经治疗的DME患者：2015年1月1日至2021年3月31日期间开始接受抗VEGF IVT治疗的DME患者（过去12个月内未接受过IVT治疗）：主要结果指标：结果包括年化注射次数、VA变化和抗VEGF药物：共有 190,345 只眼睛符合纳入标准。开始抗血管内皮生长因子静脉滴注 1 年后，眼睛平均接受了 3.9 次（±2.8）注射，视力增加了 +3.2 (±16.4) 个字母。在获得第 6 年数据的 1236 只眼睛中，第 6 年平均接受了 2.9 (±2.1) 次注射，视力比基线提高了 +0.5 (±19.7) 个字母。注射次数逐年减少，注射间隔逐年延长，直至 6 年，与基线 VA 初始值无关。第 1 年的平均注射间隔为 10 周，第 2 年扩大到 13.2 周，第 3-6 年趋于平稳（分别为 12.6、12.3、12.2 和 12.3 周）。与基线相比，每年接受 5 次或更多次注射的眼睛的视力改善幅度最大。随访结束时，基线视力良好（> 20/25）的眼睛视力下降，而基线视力较差（< 20/25）的眼睛视力上升。虽然 51.7% 的 DME 患者在平均 6 个月后停止了 IVT，但 32.8% 的患者重新开始了抗 VEGF IVT。西班牙裔（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（每增加一年，-0.06 [-0.07, -0.05]）患者的 VA 结果较差：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，也少于 FDA 批准的抗血管内皮生长因子 IVT 标签推荐的次数。

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Long-term Treatment Patterns for Diabetic Macular Edema

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.

Design

Retrospective analysis of the American Academy of Ophthalmology’s IRIS® (Intelligent Research in Sight) Registry.

Participants

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.

Main Outcome Measures

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.