Bhisitkul Robert B, Mendes Thais S, Rofagha Soraya, Enanoria Wayne, Boyer David S, Sadda SriniVas R, Zhang Kang
Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
Department of Ophthalmology, University of California, San Francisco, San Francisco, California.
Am J Ophthalmol. 2015 May;159(5):915-24.e2. doi: 10.1016/j.ajo.2015.01.032. Epub 2015 Jan 30.
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.
Follow-up analysis of long-term outcomes in a multicenter treatment cohort.
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.
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.
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.
评估雷珠单抗治疗的渗出性年龄相关性黄斑变性患者早期队列中,7至8年期间黄斑萎缩及其他关键解剖学结果的发生率和进展情况。
多中心治疗队列长期结果的随访分析。
14个研究地点从ANCHOR、MARINA和HORIZON试验的雷珠单抗治疗组中纳入了65名既往受试者。在一次更新访视中,进行了临床评估和视网膜成像研究,并与每个受试者之前在先前试验中的结果进行比较。早期糖尿病性视网膜病变研究视力是主要结局。分析包括黄斑萎缩面积和选定解剖学因素在内的次要结局与长期视力结局的相关性。
在ANCHOR或MARINA入组后的平均7.3年时,平均视力为54个字母,自HORIZON研究以来,研究眼平均每年接受1.6次注射。98%的研究眼存在黄斑萎缩,平均面积从ANCHOR或MARINA研究第2年结束时的0.83±0.96平方毫米增加到SEVEN-UP访视时的2.22±1.6平方毫米,增长率为每年0.28平方毫米。在这5年期间,黄斑萎缩的进展与视力下降显著相关(P<.001),最终黄斑萎缩病变大小与最终视力显著相关(P<.001)。其他关键解剖学结果(黄斑增厚、变薄、积液和黄斑下纤维化)对视力结局没有显著影响。
在开始对渗出性年龄相关性黄斑变性进行强化雷珠单抗治疗7年后,黄斑萎缩的进展和严重程度是视力结局的主要解剖学决定因素。