抗血管内皮生长因子治疗新生血管性年龄相关性黄斑变性后的视力结果：年龄相关性眼病研究2报告编号19
Visual Acuity Outcomes after Anti-Vascular Endothelial Growth Factor Treatment for Neovascular Age-Related Macular Degeneration: Age-Related Eye Disease Study 2 Report Number 19.
作者信息
Keenan Tiarnan D, Vitale Susan, Agrón Elvira, Domalpally Amitha, Antoszyk Andrew N, Elman Michael J, Clemons Traci E, Chew Emily Y
机构信息
Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.
Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.
出版信息
Ophthalmol Retina. 2020 Jan;4(1):3-12. doi: 10.1016/j.oret.2019.06.001. Epub 2019 Jun 11.
PURPOSE
To analyze best-corrected visual acuity (BCVA) outcomes after anti-vascular endothelial growth factor (VEGF) treatment for neovascular age-related macular degeneration (AMD).
DESIGN
Prospective cohort study of participants enrolled in a clinical trial of oral supplements and receiving anti-VEGF therapy in routine clinical practice.
PARTICIPANTS
Age-Related Eye Disease Study 2 (AREDS2) participants (50-85 years of age) whose eyes met AREDS2 inclusion criteria at baseline (no late AMD, BCVA ≥20/100, no previous anti-VEGF injections) but received at least 1 anti-VEGF injection for incident neovascular AMD during follow-up.
METHODS
Participants underwent refracted BCVA testing, ophthalmoscopic examination, and stereoscopic color fundus photography at baseline and annual study visits over 5 years. Self-reports of anti-VEGF injections (numbers, dates, and names of drug) were collected at baseline and annual study visits and during telephone calls every 6 months.
MAIN OUTCOME MEASURES
Primary outcome measures were mean refracted BCVA and proportions of eyes with BCVA of 20/40 or better and 20/200 or worse. An exploratory outcome measure was the mean number of self-reported anti-VEGF injections.
RESULTS
One thousand one hundred five eyes of 986 AREDS2 participants met the inclusion criteria; of these, 977 participants (99.1%) underwent at least 1 posttreatment visit. At the first and subsequent annual examinations after the first injection, mean refracted BCVAs were 68.0 letters (Snellen equivalent, 20/40), 66.1 letters, 64.7 letters, 63.2 letters, and 61.5 letters (Snellen equivalent, 20/60). Proportions of eyes with BCVA of 20/40 or better were 59.3%, 55.1%, 53.5%, 50.6%, and 49.7%, and those with BCVA of 20/200 or worse were 5.5%, 8.6%, 9.4%, 12.4%, and 14.4%. Mean annual numbers of self-reported anti-VEGF injections per eye were 2.9, 3.9, 3.3, 3.1, and 3.0.
CONCLUSIONS
Refracted BCVA data were obtained in a clinical trial environment but were related to anti-VEGF treatment administered in normal clinical practice. Visual outcomes declined slowly with increased follow-up time: mean BCVA decreased by approximately 1.5 to 2 letters per year. At 5 years, half of eyes achieved BCVA of 20/40 or better, but approximately one sixth showed BCVA of 20/200 or worse. These data may be useful in assessing the long-term effects of anti-VEGF therapy.
目的
分析抗血管内皮生长因子（VEGF）治疗新生血管性年龄相关性黄斑变性（AMD）后的最佳矫正视力（BCVA）结果。
设计
对参加口服补充剂临床试验并在常规临床实践中接受抗VEGF治疗的参与者进行前瞻性队列研究。
参与者
年龄相关性眼病研究2（AREDS2）参与者（50 - 85岁），其眼睛在基线时符合AREDS2纳入标准（无晚期AMD，BCVA≥20/100，既往未接受抗VEGF注射），但在随访期间因新生血管性AMD接受了至少1次抗VEGF注射。
方法
参与者在基线以及5年的年度研究访视时接受验光BCVA测试、检眼镜检查和立体彩色眼底摄影。在基线和年度研究访视时以及每6个月的电话随访中收集抗VEGF注射的自我报告（注射次数、日期和药物名称）。
主要观察指标
主要观察指标为平均验光BCVA以及BCVA为20/40或更好和20/200或更差的眼睛比例。一个探索性观察指标是自我报告的抗VEGF注射平均次数。
结果
986名AREDS2参与者的1105只眼睛符合纳入标准；其中，977名参与者（99.1%）接受了至少1次治疗后访视。在首次注射后的首次及随后年度检查中，平均验光BCVA分别为68.0字母（Snellen等效值，20/40）、66.1字母、64.7字母、63.2字母和61.5字母（Snellen等效值，20/60）。BCVA为20/40或更好的眼睛比例分别为59.3%、55.1%、53.5%、50.6%和49.7%，BCVA为20/200或更差的眼睛比例分别为5.5%、8.6%、9.4%、12.4%和14.4%。每只眼睛自我报告的抗VEGF注射平均年度次数分别为2.9、3.9、3.3、3.1和3.0。
结论
验光BCVA数据是在临床试验环境中获得的，但与正常临床实践中给予的抗VEGF治疗相关。随着随访时间延长，视力结果缓慢下降：平均BCVA每年下降约1.5至2个字母。5年后，一半的眼睛BCVA达到20/40或更好，但约六分之一的眼睛BCVA为20/200或更差。这些数据可能有助于评估抗VEGF治疗的长期效果。
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