Macular Atrophy Progression and 7-Year Vision Outcomes in Subjects From the ANCHOR, MARINA, and HORIZON Studies: the SEVEN-UP Study
Macular Atrophy Progression and 7-Year Vision Outcomes in Subjects From the ANCHOR, MARINA, and HORIZON Studies: the SEVEN-UP Study
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DOI：
10.1016/j.ajo.2015.01.032
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发表时间：
2015-05-01
影响因子：
4.2
通讯作者：
Zhang, Kang
中科院分区：
文献类型：
--
作者：
Bhisitkul, Robert B.;Mendes, Thais S.;Zhang, Kang
目的：评估接受雷珠单抗治疗的渗出性年龄相关性黄斑变性患者的早期队列中 7 至 8 年内黄斑萎缩和其他关键解剖结果的发生率和进展。设计：对多中心治疗队列中的长期结果进行随访分析。方法：14 个研究中心招募了来自 ANCHOR、MARINA 和 HORIZON 试验的雷珠单抗治疗组的 65 名既往受试者。在单次更新访问中，进行了临床评估和视网膜成像研究，并与每个受试者之前试验的结果进行比较。早期治疗糖尿病视网膜病变研究的主要结果是视力。分析了次要结果，包括黄斑萎缩面积和选定的解剖因素与长期视力结果的关联。 结果：ANCHOR 或 MARINA 入组后平均 7.3 年，平均视力为 54 个字母，自 HORIZON 研究以来，研究眼睛每年平均接受 1.6 次注射。 98% 的研究眼睛存在黄斑萎缩，平均面积从第 2 年 ANCHOR 或 MARINA 出口处的 0.83 +/- 0.96 mm(2) 增加到 SEVEN-UP 就诊时的 2.22 +/- 1.6 mm(2)，增长率为 0.28 mm(2)/年。黄斑萎缩的进展与这 5 年期间的视力下降显着相关 (P < .001)，并且最终黄斑萎缩病变大小与最终视力显着相关 (P < .001)。其他关键的解剖学结果（黄斑增厚、变薄或积液和黄斑下纤维化）对视力结果没有显着影响。结论：在开始针对渗出性年龄相关性黄斑变性的雷珠单抗强化治疗七年后，黄斑萎缩进展和严重程度是视力结果的主要解剖学决定因素。 (C) 2015 年，Elsevier Inc. 保留所有权利。
PURPOSE: To assess the incidence and progression of macular atrophy and other key anatomic outcomes over 7 to 8 years in an early cohort of ranibizumab-treated exudative age-related macular degeneration patients.DESIGN: Follow-up analysis of long-term outcomes in a multicenter treatment cohort.METHODS: Fourteen study sites enrolled 65 previous subjects from the ranibizumab treatment arms of the ANCHOR, MARINA, and HORIZON trials. In a single update visit, clinical assessment and retinal imaging studies were performed, with comparison with each subject's prior results from the previous trials. Early Treatment Diabetic Retinopathy Study visual acuity was the primary outcome. Secondary outcomes, including area of macular atrophy and selected anatomic factors, were analyzed for associations with long-term vision outcomes.RESULTS: At a mean 7.3 years after ANCHOR or MARINA enrollment, mean visual acuity was 54 letters, study eyes having received a mean 1.6 injections per year since the HORIZON study. Macular atrophy was present in 98% of study eyes, the mean area increasing from 0.83 +/- 0.96 mm(2) at the ANCHOR or MARINA year 2 exit to 2.22 +/- 1.6 mm(2) at the SEVEN-UP visit, a growth rate of 0.28 mm(2)/year. Progression of macular atrophy was associated significantly with visual decline over this 5-year period (P < .001), and final macular atrophy lesion size was related significantly to final vision (P < .001). Other key anatomic outcomes (macular thickening, thinning, or fluid and submacular fibrosis) did not have significant effects on vision outcomes.CONCLUSIONS: Seven years after initiation of intensive ranibizumab therapy for exudative age-related macular degeneration, macular atrophy progression and severity were the primary anatomic determinants of visual outcomes. (C) 2015 by Elsevier Inc. All rights reserved.