雷珠单抗治疗新生血管性年龄相关性黄斑变性患者中地理萎缩的演变
Evolution of Geographic Atrophy in Participants Treated with Ranibizumab for Neovascular Age-related Macular Degeneration.
作者信息
Thavikulwat Alisa T, Jacobs-El Naima, Kim Jane S, Agrón Elvira, Hasan Jesia, Meyerle Catherine B, Valent David, Cukras Catherine A, Wiley Henry E, Wong Wai T, Chew Emily Y
机构信息
Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD.
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD.
出版信息
Ophthalmol Retina. 2017 Jan-Feb;1(1):34-41. doi: 10.1016/j.oret.2016.09.005.
PURPOSE
To evaluate the risk factors, incidence, and rate of progression of geographic atrophy (GA) in eyes with neovascular age-related macular degeneration (nAMD) treated with ranibizumab.
DESIGN
Post-hoc analysis of a prospective clinical study.
PARTICIPANTS
69 participants with nAMD in at least one eye.
METHODS
Participants were prospectively treated in the study eye with 0.5 mg intravitreal ranibizumab. Study eyes received 4 monthly injections followed by pro re nata injections until a fluid-free macula was achieved on optical coherence tomography. Risk factors assessed included baseline demographics, treatment, and ocular characteristics on imaging. Eyes were evaluated on fundus autofluorescence (FAF) for GA. The rate of GA area growth in study and fellow eyes was analyzed by linear regression of square-root transformed areas.
MAIN OUTCOME MEASURES
Development of new-onset GA and rate of GA area growth measured on ocular imaging, including FAF images of the study eyes.
RESULTS
Sixty-nine participants (mean age 78.8±7.8 years) with an average of 40.0±13.6 months of follow-up were analyzed. Twenty-two of 69 study eyes (32%) were treatment naïve. During their first year of the study, participants received an average of 9.2±3.3 injections in the study eye. Of 63 study eyes with quality baseline images, 22 (35%) had pre-existing GA. Of the remaining 41 eyes, 7 (17%) developed new-onset GA during study follow-up. Those who developed new GA were older (all ≥79 years old) and had received fewer study injections on average (6.9 vs. 10.4 injections at 1 year) compared to those who did not develop new GA. Of the 12 treatment naïve study eyes without GA at baseline, 1 (8.3%) developed new GA during the study. In 21 study eyes with quantifiable GA area, eyes with GA present at baseline (16/21) enlarged by 0.34±0.26 mm/year, compared to 0.19±0.12 mm/year in eyes developing new-onset GA (5/21).
CONCLUSIONS
While 17% of study eyes without GA present at baseline receiving ranibizumab developed new GA, the role of ranibizumab in the development of GA is unclear. Further prospective longitudinal studies are required to determine the eyes most at risk of developing GA in the setting of anti-VEGF treatment.
目的
评估接受雷珠单抗治疗的新生血管性年龄相关性黄斑变性（nAMD）患眼中地图样萎缩（GA）的危险因素、发病率及进展速率。
设计
一项前瞻性临床研究的事后分析。
参与者
69名至少一只眼患有nAMD的参与者。
方法
对研究眼进行前瞻性治疗，玻璃体内注射0.5mg雷珠单抗。研究眼每月注射4次，之后根据需要注射，直至光学相干断层扫描显示黄斑区无液性暗区。评估的危险因素包括基线人口统计学特征、治疗情况及影像学检查的眼部特征。通过眼底自发荧光（FAF）对眼睛进行GA评估。通过对平方根转换后的面积进行线性回归分析研究眼和对侧眼中GA面积的增长速率。
主要观察指标
通过眼部影像学检查，包括研究眼的FAF图像，测量新发GA的发生情况及GA面积的增长速率。
结果
分析了69名参与者（平均年龄78.8±7.8岁），平均随访时间为40.0±13.6个月。69只研究眼中有22只（32%）为初治眼。在研究的第一年，参与者的研究眼平均接受了9.2±3.3次注射。在63只具有高质量基线图像的研究眼中，22只（35%）存在既往GA。在其余41只眼中，7只（17%）在研究随访期间出现了新发GA。与未出现新发GA的患者相比，出现新发GA的患者年龄更大（均≥79岁），且平均接受的研究注射次数更少（1年时分别为6.9次和10.4次）。在12只基线时无GA的初治研究眼中，1只（8.3%）在研究期间出现了新发GA。在21只GA面积可量化的研究眼中，基线时存在GA的眼（16/21）每年扩大0.34±0.26mm，而出现新发GA的眼（5/21）每年扩大0.19±0.12mm。
结论
虽然基线时无GA的接受雷珠单抗治疗的研究眼中有17%出现了新发GA，但雷珠单抗在GA发生中的作用尚不清楚。需要进一步进行前瞻性纵向研究，以确定在抗VEGF治疗背景下最易发生GA的眼。
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