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新生血管性年龄相关性黄斑变性中黄斑新生血管病变类型与视力结局:HARBOR 的事后分析。

Macular neovascularization lesion type and vision outcomes in neovascular age-related macular degeneration: post hoc analysis of HARBOR.

机构信息

Vitreous Retina Macula Consultants of New York, New York, NY, USA.

Department of Ophthalmology, NYU Grossman School of Medicine, New York, NY, USA.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2022 Aug;260(8):2437-2447. doi: 10.1007/s00417-022-05586-w. Epub 2022 Mar 3.

Abstract

PURPOSE

To characterize relationships between Consensus on Neovascular Age-Related Macular Degeneration Nomenclature (CONAN) Study Group classifications of macular neovascularization (MNV) and visual responses to ranibizumab in patients with neovascular age-related macular degeneration (nAMD).

METHODS

This was a post hoc analysis of the phase 3 HARBOR trial of ranibizumab in nAMD. Analyses included ranibizumab-treated eyes with baseline multimodal imaging data; baseline MNV; subretinal and/or intraretinal fluid at screening, baseline, or week 1; and spectral-domain optical coherence tomography images through month 24 (n = 700). Mean best-corrected visual acuity (BCVA) over time and mean BCVA change at months 12 and 24 were compared between eyes with type 1, type 2/mixed type 1 and 2 (type 2/M), and any type 3 MNV at baseline.

RESULTS

At baseline, 263 (37.6%), 287 (41.0%), and 150 (21.4%) eyes had type 1, type 2/M, and any type 3 lesions, respectively. Type 1 eyes had the best mean BCVA at baseline (59.0 [95% CI: 57.7-60.3] letters) and month 24 (67.7 [65.8-69.6] letters), whereas type 2/M eyes had the worst (50.0 [48.6-51.4] letters and 60.8 [58.7-62.9] letters, respectively). Mean BCVA gains at month 24 were most pronounced for type 2/M eyes (10.8 [8.9-12.7] letters) and similar for type 1 (8.7 [6.9-10.5] letters) and any type 3 eyes (8.3 [6.3-10.3] letters).

CONCLUSION

Differences in BCVA outcomes between CONAN lesion type subgroups support the use of an anatomic classification system to characterize MNV and prognosticate visual responses to anti-vascular endothelial growth factor therapy for nAMD.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT00891735. Date of registration: April 29, 2009.

摘要

目的

描述共识性新生血管年龄相关性黄斑变性命名(CONAN)研究组对黄斑新生血管(MNV)的分类与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(nAMD)患者视力反应之间的关系。

方法

这是雷珠单抗治疗 nAMD 的 3 期 HARBOR 试验的事后分析。分析包括基线多模态成像数据、基线 MNV、筛查时、基线或第 1 周时的视网膜下和/或视网膜内液、以及通过第 24 个月的频域光学相干断层扫描图像的接受雷珠单抗治疗的眼(n=700)。比较基线时存在 1 型、2 型/1 型和 2 型混合(2 型/M)和任何 3 型 MNV 的眼之间的平均最佳矫正视力(BCVA)随时间的变化和第 12 个月和第 24 个月的平均 BCVA 变化。

结果

基线时,263(37.6%)、287(41.0%)和 150(21.4%)只眼分别具有 1 型、2 型/M 和任何 3 型病变。1 型眼的基线时最佳平均 BCVA(59.0[95%置信区间:57.7-60.3]个字母)和第 24 个月(67.7[65.8-69.6]个字母),而 2 型/M 眼最差(50.0[48.6-51.4]个字母和 60.8[58.7-62.9]个字母,分别)。第 24 个月时,2 型/M 眼的平均 BCVA 增益最显著(10.8[8.9-12.7]个字母),而 1 型和任何 3 型眼相似(8.7[6.9-10.5]个字母和 8.3[6.3-10.3]个字母)。

结论

CONAN 病变亚组之间 BCVA 结果的差异支持使用解剖学分类系统来描述 MNV,并预测抗血管内皮生长因子治疗 nAMD 的视力反应。

临床试验注册

ClinicalTrials.gov 标识符:NCT00891735。注册日期:2009 年 4 月 29 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48fc/8891431/4c386a024265/417_2022_5586_Fig1_HTML.jpg

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