五年期年龄相关性黄斑变性治疗试验比较的黄斑形态和视力。
Macular Morphology and Visual Acuity in Year Five of the Comparison of Age-related Macular Degeneration Treatments Trials.
机构信息
Department of Ophthalmology, Duke University, Durham, North Carolina.
Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.
出版信息
Ophthalmology. 2019 Feb;126(2):252-260. doi: 10.1016/j.ophtha.2018.08.035. Epub 2018 Sep 3.
PURPOSE
To evaluate associations of morphologic features with 5-year visual acuity (VA) in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT).
DESIGN
Cohort study within a randomized clinical trial.
PARTICIPANTS
Participants in CATT.
METHODS
Eyes with age-related macular degeneration-associated choroidal neovascularization (CNV) and VA between 20/25 and 20/320 were eligible. Treatment was assigned randomly to ranibizumab or bevacizumab and to 3 dosing regimens for 2 years and was at the ophthalmologists' discretion thereafter.
MAIN OUTCOME MEASURES
Visual acuity, thickness and morphologic features on OCT, and lesion size and foveal composition on fundus photography (FP) and fluorescein angiography (FA).
RESULTS
Visual acuity and image gradings were available for 523 of 914 participants (57%) alive at 5 years. At 5 years, 60% of eyes had intraretinal fluid (IRF), 38% had subretinal fluid (SRF), 36% had subretinal pigment epithelium (RPE) fluid, and 66% had subretinal hyper-reflective material (SHRM). Mean (standard deviation) foveal center thickness was 148 μm (99) for retina, 5 μm (21) for SRF, 125 μm (107) for subretinal tissue complex, 11 μm (33) for SHRM, and 103 μm (95) for RPE + RPE elevation. The SHRM, thinner retina, greater CNV lesion area, and foveal center pathology (all P < 0.001) and IRF (P < 0.05) were independently associated with worse VA. Adjusted mean VA letters were 62 for no pathology in the foveal center; 61 for CNV, fluid, or hemorrhage; 65 for non-geographic atrophy (GA); 64 for nonfibrotic scar; 53 for GA; and 56 for fibrotic scar. Incidence or worsening of 8 pathologic features (foveal GA, foveal scar, foveal CNV, SHRM, foveal IRF, retinal thinning, CNV lesion area, and GA area) between years 2 and 5 was independently associated with greater loss of VA from years 2 to 5 and VA loss from baseline to year 5.
CONCLUSIONS
Associations between VA and morphologic features previously identified through year 1 were maintained or strengthened at year 5. New foveal scar, CNV, intraretinal fluid, SHRM and retinal thinning, development or worsening of foveal GA, and increased lesion size are important contributors to the VA decline from years 2 to 5. A significant need to develop therapies to address these adverse pathologic features remains.
目的
评估形态特征与 5 年视力（VA）的相关性在年龄相关性黄斑变性治疗试验比较（CATT）中。
设计
在一项随机临床试验中进行的队列研究。
参与者
CATT 的参与者。
方法
患有年龄相关性黄斑变性相关脉络膜新生血管（CNV）和 VA 在 20/25 至 20/320 之间的眼睛符合条件。治疗随机分配给雷珠单抗或贝伐单抗，并在 2 年内分配 3 种剂量方案，此后由眼科医生决定。
主要观察指标
VA、OCT 上的厚度和形态特征，眼底照相（FP）和荧光素血管造影（FA）上的病变大小和中心凹组成。
结果
在 5 年内存活的 914 名参与者中有 523 名（57%）有视力和图像分级。5 年后，60%的眼睛有视网膜内液（IRF），38%的眼睛有视网膜下液（SRF），36%的眼睛有视网膜下色素上皮（RPE）液，66%的眼睛有视网膜下高反射物质（SHRM）。中心凹厚度的平均值（标准差）为视网膜 148μm（99），SRF 5μm（21），视网膜下组织复合体 125μm（107），SHRM 11μm（33），RPE+RPE 隆起 103μm（95）。SHRM、较薄的视网膜、更大的 CNV 病变面积以及中心凹病理学（均 P<0.001）和 IRF（P<0.05）与较差的 VA 独立相关。调整后的平均 VA 字母分别为：中心凹无病理学 62；CNV、液体积聚或出血 61；非地理性萎缩（GA）65；非纤维化瘢痕 64；GA 64；纤维化瘢痕 56。2 至 5 年内出现或加重 8 种病理学特征（中心凹 GA、中心凹瘢痕、中心凹 CNV、SHRM、中心凹 IRF、视网膜变薄、CNV 病变面积和 GA 面积）与 2 至 5 年内 VA 损失增加以及从基线到第 5 年的 VA 损失独立相关。
结论
第 1 年通过 VA 和形态特征之间的关联在第 5 年得到维持或加强。新的中心凹瘢痕、CNV、视网膜内液、SHRM 和视网膜变薄、中心凹 GA 的发展或恶化以及病变大小的增加是 2 至 5 年内 VA 下降的重要原因。仍然需要开发针对这些不良病理学特征的治疗方法。
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