Leng Theodore, Schwartz Jason, Nimke David, Gallivan Mark, Fevrier Helene, Rozario Nigel, Schultz Neil M
Byers Eye Institute at Stanford, Stanford University School of Medicine, Palo Alto, CA, USA.
Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.
Ophthalmol Ther. 2023 Feb;12(1):325-340. doi: 10.1007/s40123-022-00583-y. Epub 2022 Nov 11.
Understanding the progression to geographic atrophy (GA) in late dry age-related macular degeneration (dAMD) can support development opportunities for dAMD treatments. We characterized dAMD by distribution of visual acuity (VA) categories and evaluated VA progression risk by disease stage.
This retrospective observational study used data from the American Academy of Ophthalmology IRIS Registry (Intelligent Research in Sight) to identify patients diagnosed with dAMD in ≥ 1 eye from January 2016 through December 2019 (index date) with ≥ 1 visit and ≥ 1 VA measurement recorded post-index date. Patients were followed until the date of last visit, last contribution for diagnosing provider, or diagnosis of neovascular AMD post-index. Models were utilized to describe the distribution of VA categories and progression to worsening VA.
Data from 593,277 patients were analyzed. At baseline, 64.4% had mild disease, 29.4% intermediate, and 2.9%/3.3% had GA with/without subfoveal involvement. Most patients with mild (88.4%) and intermediate (79.7%) disease and GA without subfoveal involvement (57.1%) had baseline VA ≥ 20/63 in the study eye; 72.0% of patients with GA with subfoveal involvement had VA < 20/63. Modeled results showed lower VA with more progressive stage at baseline. Annual probability of stable dAMD based on baseline stage ranged from 82.1% (GA without) to 92.3% (GA with subfoveal involvement). Annual progression probability to GA without/with subfoveal involvement was 0.4% for mild and 5.5% for intermediate disease and from dry to neovascular AMD, 0.5% for mild and 8.0% for intermediate disease.
Results from this analysis of a large database of electronic health records complement those from randomized trials and show that patients with more advanced dAMD have lower VA at baseline and that VA progression is generally faster with each progressive stage. Together these findings highlight the disease burden and trajectory of dAMD as well as opportunities for addressing unmet needs.
了解晚期干性年龄相关性黄斑变性(dAMD)向地图样萎缩(GA)的进展情况有助于为dAMD治疗创造发展机会。我们通过视力(VA)类别分布对dAMD进行了特征描述,并按疾病阶段评估了VA进展风险。
这项回顾性观察性研究使用了美国眼科学会IRIS注册中心(视力智能研究)的数据,以识别2016年1月至2019年12月期间(索引日期)至少一只眼睛被诊断为dAMD且索引日期后有至少一次就诊记录和至少一次VA测量值的患者。对患者进行随访,直至最后一次就诊日期、诊断医生的最后一次诊断贡献日期或索引日期后新生血管性AMD的诊断日期。利用模型描述VA类别的分布以及VA恶化的进展情况。
分析了593,277名患者的数据。基线时,64.4%为轻度疾病,29.4%为中度疾病,2.9%/3.3%有GA伴/不伴黄斑中心凹受累。大多数轻度(88.4%)和中度(79.7%)疾病以及无黄斑中心凹受累的GA患者(57.1%)研究眼的基线VA≥20/63;72.0%有黄斑中心凹受累的GA患者VA<20/63。模型结果显示,基线时病情进展越严重,VA越低。基于基线阶段的dAMD病情稳定的年概率范围为82.1%(无GA)至92.3%(有黄斑中心凹受累的GA)。轻度疾病向无/有黄斑中心凹受累的GA进展的年概率分别为0.4%和5.5%,从干性向新生血管性AMD进展的年概率,轻度疾病为0.5%,中度疾病为8.0%。
对一个大型电子健康记录数据库的分析结果补充了随机试验的结果,表明dAMD病情越严重的患者基线时VA越低,且随着病情进展,VA进展通常越快。这些发现共同凸显了dAMD的疾病负担和发展轨迹以及满足未满足需求的机会。