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Five-Year Follow-up of Nonfibrotic Scars in the Comparison of Age-Related Macular Degeneration Treatments Trials.
Ophthalmology ( IF 13.1 ) Pub Date : 2018-11-23 , DOI: 10.1016/j.ophtha.2018.11.020
Ebenezer Daniel 1 , Gui-Shuang Ying 1 , Benjamin J Kim 1 , Cynthia A Toth 2 , Frederick Ferris 3 , Daniel F Martin 4 , Juan E Grunwald 1 , Glenn J Jaffe 2 , Joshua L Dunaief 1 , Wei Pan 1 , Maureen G Maguire 1 ,
Affiliation  

PURPOSE To describe changes in visual acuity (VA) and macular morphologic features at 5 years in eyes with nonfibrotic scar (NFS) identified at 1 year in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). DESIGN Prospective cohort study within a randomized clinical trial. PARTICIPANTS Participants in CATT. METHODS Participants assigned to ranibizumab or bevacizumab and to 1 of 3 dosing regimens were released from the clinical trial protocol after 2 years and recalled at 5 years. Nonfibrotic scar was identified on color images at year 1 as flat, small, well-circumscribed areas of pigmentation with varying degrees of central hypopigmentation without exposure of underlying choroidal vessels at the site of baseline choroidal neovascularization. Follow-up images were assessed for changes in and around NFS. MAIN OUTCOME MEASURES Pigmentation changes, VA, development of fibrotic scar (FS), nongeographic atrophy (NGA), geographic atrophy (GA), retinal fluid on OCT, and fluorescein leakage. RESULTS Among 474 eyes with images obtained at 1, 2, and 5 years, 39 (8.2%) showed NFS at 1 year with a mean VA of 80 letters (Snellen equivalent, 20/25). Among these eyes, FS developed in 5% at 2 years and 28% at 5 years. Nongeographic atrophy was observed in 34%, 47%, and 65% of eyes at 1, 2, and 5 years, respectively. Geographic atrophy developed in 5% of eyes at 2 years and 21% at 5 years. Among eyes with NFS, FS, or no scar at 1 year, mean VA at 5 years was 73 letters (20/32), 48 letters (20/100), and 62 letters (20/63), respectively. At 5 years, NFS eyes demonstrated less GA, less intraretinal fluid, more subretinal fluid, and less subretinal pigment epithelium fluid (all P < 0.01). Among NFS eyes, mean thickness of the retina, subretinal tissue complex, and total retina did not change across years 1 to 5 (P > 0.50). The proportion of eyes with fluid on OCT also did not change (P = 0.36). Subretinal hyperreflective material disappeared by 5 years in 40% of eyes with NFS. CONCLUSIONS These results indicate that, on average, eyes with NFS after anti-VEGF treatment have good VA not only at 1 and 2 years, but also through 5 years.

中文翻译:

年龄相关性黄斑变性治疗试验比较中非纤维化疤痕的五年随访。

目的 描述年龄相关性黄斑变性治疗试验 (CATT) 比较中 1 岁时发现的非纤维化疤痕 (NFS) 眼睛在 5 岁时的视力 (VA) 和黄斑形态特征的变化。设计随机临床试验中的前瞻性队列研究。参与者 CATT 参与者。方法 被分配接受雷珠单抗或贝伐单抗以及 3 种给药方案中的 1 种的参与者在 2 年后从临床试验方案中退出,并在 5 年后被召回。在第一年的彩色图像上,非纤维化疤痕被识别为平坦、小、界限清楚的色素沉着区域,具有不同程度的中央色素沉着不足,在基线脉络膜新生血管形成部位没有暴露下面的脉络膜血管。评估后续图像中 NFS 及其周围的变化。主要观察指标:色素沉着变化、VA、纤维化疤痕(FS)的发展、非地理性萎缩(NGA)、地理性萎缩(GA)、OCT 上的视网膜液体和荧光素渗漏。结果 在 1、2 和 5 年获得图像的 474 只眼睛中,39 只 (8.2%) 在 1 年时显示 NFS,平均 VA 为 80 个字母(Snellen 等效值,20/25)。这些眼睛中,2 岁时 FS 发生率为 5%,5 岁时发生 28%。在 1 年、2 年和 5 年时,分别有 34%、47% 和 65% 的眼睛出现非地理性萎缩。5% 的眼睛在 2 岁时出现地理萎缩,21% 的眼睛在 5 岁时出现地理萎缩。在 1 年时患有 NFS、FS 或无疤痕的眼睛中,5 年时的平均 VA 分别为 73 个字母 (20/32)、48 个字母 (20/100) 和 62 个字母 (20/63)。5 年时,NFS 眼表现出 GA 较少、视网膜内液较少、视网膜下液较多、视网膜下色素上皮液较少(所有 P < 0.01)。在 NFS 眼中,视网膜、视网膜下组织复合体和总视网膜的平均厚度在 1 至 5 年内没有变化(P > 0.50)。OCT 上有液体的眼睛比例也没有变化 (P = 0.36)。40% 的 NFS 眼睛的视网膜下高反射物质在 5 年内消失。结论 这些结果表明,平均而言,抗 VEGF 治疗后患有 NFS 的眼睛不仅在 1 年和 2 年,而且在整个 5 年都具有良好的 VA。
更新日期:2018-11-23
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