Grunwald Juan E, Pistilli Maxwell, Daniel Ebenezer, Ying Gui-Shuang, Pan Wei, Jaffe Glenn J, Toth Cynthia A, Hagstrom Stephanie A, Maguire Maureen G, Martin Daniel F
Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
Ophthalmology. 2017 Jan;124(1):97-104. doi: 10.1016/j.ophtha.2016.09.012. Epub 2016 Oct 27.
To estimate the incidence, size, and growth rate of geographic atrophy (GA) during 5 years of follow-up among participants in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT).
Cohort within a clinical trial.
Participants included in CATT.
A total of 1185 CATT participants were randomly assigned to ranibizumab or bevacizumab treatment and to 3 treatment regimens. Participants were released from protocol treatment at 2 years and examined at approximately 5 years (N = 647). Two masked graders assessed the presence and size of GA in digital color photographs (CPs) and fluorescein angiograms (FAs) taken at baseline and years 1, 2, and 5. Cox proportional hazard models were used to identify risk factors for incidence of GA. Annual change in the square root of the total area of GA was the measure of growth. Multivariate linear mixed models including baseline demographic, treatment, and ocular characteristics on CP/FA and optical coherence tomography (OCT) as candidate risk factors were used to estimate adjusted growth rates, standard errors (SEs), and 95% confidence intervals (CIs).
Geographic atrophy incidence and growth rate.
Among the 1011 participants who did not have GA at baseline and had follow-up images gradable for GA, the cumulative incidence was 12% at 1 year, 17% at 2 years, and 38% at 5 years. At baseline, older age, hypercholesterolemia, worse visual acuity, larger choroidal neovascularization (CNV) area, retinal angiomatous proliferation (RAP) lesion, GA in the fellow eye, and intraretinal fluid were associated with a higher risk of incident GA. Thicker subretinal tissue complex and presence of subretinal fluid were associated with less GA development. The overall GA growth rate was 0.33 mm/year (SE, 0.02 mm/year). Eyes treated with ranibizumab in the first 2 years of the clinical trial had a higher growth rate than eyes treated with bevacizumab (adjusted growth rate, 0.38 vs. 0.28 mm/year; P = 0.009). Geographic atrophy in the fellow eye, hemorrhage, and absence of sub-retinal pigment epithelium fluid at baseline were associated with a higher growth rate.
Development of GA is common 5 years after initiating therapy. Several risk factors identified at 2 years of follow-up persist at 5 years of follow-up.
评估年龄相关性黄斑变性治疗试验（CATT）参与者在5年随访期间地理萎缩（GA）的发病率、大小及生长速率。
临床试验中的队列研究。
CATT纳入的参与者。
1185名CATT参与者被随机分配接受雷珠单抗或贝伐单抗治疗，并分为3种治疗方案。参与者在2年时结束方案治疗，并在大约5年时接受检查（N = 647）。两名经过盲法训练的分级人员评估了在基线、第1年、第2年和第5年拍摄的数字彩色照片（CP）和荧光素血管造影（FA）中GA的存在情况和大小。使用Cox比例风险模型确定GA发病的危险因素。GA总面积平方根的年变化作为生长的测量指标。使用多变量线性混合模型，将CP/FA和光学相干断层扫描（OCT）上的基线人口统计学、治疗和眼部特征作为候选危险因素，以估计调整后的生长速率、标准误（SE）和95%置信区间（CI）。
地理萎缩发病率和生长速率。
在基线时没有GA且有可用于GA分级的随访图像的1011名参与者中，1年时的累积发病率为12%，2年时为17%，5年时为38%。在基线时，年龄较大、高胆固醇血症、视力较差、脉络膜新生血管（CNV）面积较大、视网膜血管瘤样增生（RAP）病变、对侧眼有GA以及视网膜内液与GA发病风险较高相关。视网膜下组织复合体较厚和存在视网膜下液与GA进展较少相关。GA的总体生长速率为0.33 mm/年（SE，0.02 mm/年）。在临床试验的前2年接受雷珠单抗治疗的眼睛比接受贝伐单抗治疗的眼睛生长速率更高（调整后的生长速率，0.38对0.28 mm/年；P = 0.009）。对侧眼有GA、出血以及基线时不存在视网膜色素上皮下液与较高的生长速率相关。
开始治疗5年后GA的发生很常见。在随访2年时确定的几个危险因素在随访5年时仍然存在。
