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临床研究中高龄相关性黄斑变性的影像学方案:来自萎缩共识会议分类的建议。

Imaging Protocols in Clinical Studies in Advanced Age-Related Macular Degeneration: Recommendations from Classification of Atrophy Consensus Meetings.

机构信息

Department of Ophthalmology, University of Bonn, Bonn, Germany.

Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.

出版信息

Ophthalmology. 2017 Apr;124(4):464-478. doi: 10.1016/j.ophtha.2016.12.002. Epub 2017 Jan 18.

DOI:10.1016/j.ophtha.2016.12.002
PMID:28109563
Abstract

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 neovascularization [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.

摘要

目的

总结 2 次共识会议(萎缩分类会议[CAM])的结果,这些会议涉及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)所致萎缩的常规和先进成像方式,并就这些方式在自然史研究和干预性临床试验中的应用提供建议。

设计

在 2 次共识会议上就不同成像方式的相关性进行系统辩论。

参与者

一组视网膜专家。

方法

在 CAM 会议期间,一个国际专家联盟根据对大量临床病例的综合分析,评估了各种成像方式的优缺点。就每种方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。

主要观察指标

当前视网膜成像技术的优缺点,以及在晚期 AMD 试验中应用这些技术的建议。

结果

用于检测、量化和监测萎缩进展的成像方案应包括彩色眼底照相术(CFP)、共焦眼底荧光素血管造影(FAF)、共焦近红外反射(NIR)和高分辨率光相干断层扫描容积扫描。这些图像应在整个研究过程中定期采集。在非新生血管性 AMD 研究中(基线时无明显活跃或消退性新生血管[NV]迹象),基线和研究结束时的 CFP 可能就足够了。在研究过程中的任何一次就诊时,可能都需要进行荧光素血管造影(FA)以评估 NV。在某些情况下,可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,必须考虑到对血管可视化的需求增加。因此,这些研究应包括 FA(推荐在基线和特定随访时进行)和 ICG-A(在某些情况下进行)。

结论

建议在临床研究中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。需要进行特定的验证研究,以确定最佳的成像方式组合,并且随着未来新的成像技术的出现,这些建议需要不断更新。

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