Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration
Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration
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DOI：
10.1016/j.ophtha.2016.12.002
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发表时间：
2017-04-01
期刊：
影响因子：
13.7
通讯作者：
Schmitz-Valckenberg, Steffen
中科院分区：
文献类型：
--
作者：
Holz, Frank G.;Sadda, SriniVas R.;Schmitz-Valckenberg, Steffen
目的：总结关于用于检测和量化晚期非新生血管性和新生血管性年龄相关性黄斑变性（AMD）引起的萎缩的常规和先进成像方式的两次共识会议（萎缩分类会议[CAM]）的结果，并就这些方式在自然史研究和介入临床试验中的使用提供建议。设计：关于不同成像的相关性的系统辩论 参加者：视网膜专家小组。方法：在 CAM 期间，国际专家组成的联盟在对大量临床病例进行集体分析的基础上评估了各种成像方式的优缺点。对每种模式在非新生血管性和新生血管性 AMD 未来研究中的作用进行了系统讨论。主要结果指标：当前视网膜成像技术的优点和缺点以及在高级 AMD 试验中使用这些技术的建议。结果：检测、量化和监测萎缩进展的成像方案应包括彩色眼底照相 (CFP)、共焦眼底自发荧光 (FAF)、共焦近红外反射 (NIR) 和高分辨率光学相干断层扫描体积扫描。在整个研究过程中应定期采集这些图像。在非新生血管性 AMD 的研究中（基线时没有明显的活动性或消退性新生血管形成 [NV] 迹象），在基线和研究结束访视时 CFP 可能就足够了。在研究期间的任何访视中，可能需要进行荧光素血管造影 (FA) 来评估 NV。在某些情况下，可以考虑在基线时进行吲哚菁绿血管造影（ICG-A）。对于新生血管性 AMD 患者的研究，必须考虑到对脉管系统可视化的需求增加。因此，这些研究应包括某些条件下的 FA（建议在基线和选定的随访中进行）和 ICG-A。结论：在临床研究中建议采用多模态成像方法，以最佳地检测和测量萎缩及其相关特征。需要进行具体的验证研究来确定成像方式的最佳组合，并且随着未来新成像技术的出现，这些建议也需要更新。 (C) 2017 年美国眼科学会
Purpose: To summarize the results of 2 consensus meetings (Classification of Atrophy Meeting [ CAM]) on conventional and advanced imaging modalities used to detect and quantify atrophy due to late-stage non-neovascular and neovascular age-related macular degeneration (AMD) and to provide recommendations on the use of these modalities in natural history studies and interventional clinical trials.Design: Systematic debate on the relevance of distinct imaging modalities held in 2 consensus meetings.Participants: A panel of retina specialists.Methods: During the CAM, a consortium of international experts evaluated the advantages and disadvantages of various imaging modalities on the basis of the collective analysis of a large series of clinical cases. A systematic discussion on the role of each modality in future studies in non-neovascular and neovascular AMD was held.Main Outcome Measures: Advantages and disadvantages of current retinal imaging technologies and recommendations for their use in advanced AMD trials.Results: Imaging protocols to detect, quantify, and monitor progression of atrophy should include color fundus photography (CFP), confocal fundus autofluorescence (FAF), confocal near-infrared reflectance (NIR), and high-resolution optical coherence tomography volume scans. These images should be acquired at regular intervals throughout the study. In studies of non-neovascular AMD (without evident signs of active or regressed neo-vascularization [NV] at baseline), CFP may be sufficient at baseline and end-of-study visit. Fluorescein angiography (FA) may become necessary to evaluate for NV at any visit during the study. Indocyanine-green angiography (ICG-A) may be considered at baseline under certain conditions. For studies in patients with neovascular AMD, increased need for visualization of the vasculature must be taken into account. Accordingly, these studies should include FA (recommended at baseline and selected follow-up visits) and ICG-A under certain conditions.Conclusions: A multimodal imaging approach is recommended in clinical studies for the optimal detection and measurement of atrophy and its associated features. Specific validation studies will be necessary to determine the best combination of imaging modalities, and these recommendations will need to be updated as new imaging technologies become available in the future. (C) 2017 by the American Academy of Ophthalmology