Department of Ophthalmology and Optometry, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.
Prog Retin Eye Res. 2024 Nov;103:101305. doi: 10.1016/j.preteyeres.2024.101305. Epub 2024 Sep 27.
Regulatory approval of the first two therapeutic substances for the management of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) is a major breakthrough following failure of numerous previous trials. However, in the absence of therapeutic standards, diagnostic tools are a key challenge as functional parameters in GA are hard to provide. The majority of anatomical biomarkers are subclinical, necessitating advanced and sensitive image analyses. In contrast to fundus autofluorescence (FAF), optical coherence tomography (OCT) provides high-resolution visualization of neurosensory layers, including photoreceptors, and other features that are beyond the scope of human expert assessment. Artificial intelligence (AI)-based methodology strongly enhances identification and quantification of clinically relevant GA-related sub-phenotypes. Introduction of OCT-based biomarker analysis provides novel insight into the pathomechanisms of disease progression and therapeutic, moving beyond the limitations of conventional descriptive assessment. Accordingly, the Food and Drug Administration (FDA) has provided a paradigm-shift in recognizing ellipsoid zone (EZ) attenuation as a primary outcome measure in GA clinical trials. In this review, the transition from previous to future GA classification and management is described. With the advent of AI tools, diagnostic and therapeutic concepts have changed substantially in monitoring and screening of GA disease. Novel technology combined with pathophysiological knowledge and understanding of the therapeutic response to GA treatments, is currently opening the path for an automated, efficient and individualized patient care with great potential to improve access to timely treatment and reduce health disparities.
监管部门批准了前两种治疗物质,用于治疗与年龄相关的黄斑变性(AMD)相关的地理萎缩(GA),这是在多次失败的试验之后的重大突破。然而,由于缺乏治疗标准,诊断工具是一个关键挑战,因为 GA 的功能参数难以提供。大多数解剖学生物标志物是亚临床的,需要先进和敏感的图像分析。与眼底自发荧光(FAF)相比,光学相干断层扫描(OCT)提供了神经感觉层的高分辨率可视化,包括感光器,以及超出人类专家评估范围的其他特征。基于人工智能(AI)的方法强烈增强了对临床相关 GA 相关亚表型的识别和量化。基于 OCT 的生物标志物分析的引入为疾病进展和治疗的病理机制提供了新的见解,超越了传统描述性评估的局限性。因此,美国食品和药物管理局(FDA)在 GA 临床试验中,将椭圆体带(EZ)衰减作为主要的疗效指标,实现了范式转变。在这篇综述中,描述了从以前到未来 GA 分类和管理的转变。随着 AI 工具的出现,诊断和治疗概念在 GA 疾病的监测和筛查方面发生了重大变化。新技术与病理生理学知识相结合,以及对 GA 治疗反应的理解,目前正在为自动化、高效和个体化的患者护理开辟道路,具有极大的潜力改善及时治疗的机会,并减少健康差异。