玻璃体黄斑界面在年龄相关性黄斑变性治疗试验比较中对治疗结果的影响。
Influence of the Vitreomacular Interface on Treatment Outcomes in the Comparison of Age-Related Macular Degeneration Treatments Trials.
作者信息
Ciulla Thomas A, Ying Gui-Shuang, Maguire Maureen G, Martin Daniel F, Jaffe Glenn J, Grunwald Juan E, Daniel Ebenezer, Toth Cynthia A
机构信息
Midwest Eye Institute, Indianapolis, Indiana.
Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.
出版信息
Ophthalmology. 2015 Jun;122(6):1203-11. doi: 10.1016/j.ophtha.2015.02.031. Epub 2015 Mar 29.
OBJECTIVE
To assess the association of the vitreomacular interface with outcomes of eyes treated with anti-vascular endothelial growth factor drugs for neovascular age-related macular degeneration (AMD).
DESIGN
Prospective cohort study within a multicenter, randomized clinical trial.
PARTICIPANTS
Patients enrolled in the Comparison of AMD Treatments Trials (CATT).
METHODS
Treatment was assigned randomly as either ranibizumab or bevacizumab and as 3 different regimens for dosing over a 2-year period. Masked readers at a reading center assessed optical coherence tomography (OCT) scans at baseline and follow-up for vitreomacular traction (VMT) and vitreomacular adhesion (VMA), fluid, and central thickness. Visual acuity (VA) was measured by masked, certified examiners.
MAIN OUTCOME MEASURES
Anatomic features and VA at baseline and 1 and 2 years and number of treatments.
RESULTS
At baseline, 143 patient eyes (12.8%) had VMT or VMA. Compared with those with neither (n = 972), patients with VMT or VMA were younger (mean ± standard error, 75.5 ± 0.6 vs. 79.7 ± 0.24 years; P < 0.0001) and more likely to be male (52.4% vs. 36.2%; P = 0.0003), to be cigarette smokers (68.5% vs. 55.3%; P = 0.003), and to have subretinal fluid on OCT (86.7% vs. 81.0%; P = 0.047). Vitreomacular interface status was not associated with VA at baseline or follow-up. Among eyes treated as needed (n = 598) and followed up for 2 years (n = 516), the mean number of injections was 15.4 ± 0.9 for eyes having VMT at baseline or during follow-up (n = 60), 13.8 ± 0.7 for eyes with VMA at baseline or follow-up (n = 79), and 12.9 ± 0.4 (P = 0.02) for eyes without VMT or VMA (n = 377). In addition, the mean number of injections in eyes treated as needed increased from 13.0 ± 0.3 when VMT was not observed to 13.6 ± 1.3 when observed once and to 17 ± 1.2 when observed more than once during follow-up. At 2 years, geographic atrophy developed in a lower percentage of eyes with VMT or VMA at baseline (11.7%) than with neither condition (22.5%; P = 0.005).
CONCLUSIONS
In eyes in the CATT, VMT and VMA were infrequent. At baseline and follow-up, VMT or VMA were not associated with VA. Eyes with VMT or VMA treated as needed required on average 2 more injections over 2 years.
目的
评估玻璃体黄斑界面与接受抗血管内皮生长因子药物治疗的新生血管性年龄相关性黄斑变性（AMD）患眼预后的相关性。
设计
一项多中心随机临床试验中的前瞻性队列研究。
参与者
年龄相关性黄斑变性治疗试验（CATT）的入组患者。
方法
随机分配治疗方案，分为雷珠单抗或贝伐单抗，并在2年期间采用3种不同的给药方案。阅读中心的盲法阅片者在基线和随访时评估光学相干断层扫描（OCT）图像，以观察玻璃体黄斑牵拉（VMT）、玻璃体黄斑粘连（VMA）、积液和中心厚度。视力（VA）由盲法认证检查者测量。
主要观察指标
基线、1年和2年时的解剖学特征和视力以及治疗次数。
结果
基线时，143只患眼（12.8%）存在VMT或VMA。与两者均无的患眼（n = 972）相比，存在VMT或VMA的患者更年轻（平均±标准误，75.5±0.6岁对79.7±0.24岁；P < 0.0001），男性比例更高（52.4%对36.2%；P = 0.0003），吸烟比例更高（68.5%对55.3%；P = 0.003），且OCT显示视网膜下积液的比例更高（86.7%对81.0%；P = 0.047）。玻璃体黄斑界面状态与基线或随访时的视力无关。在按需治疗（n = 598）并随访2年（n = 516）的患眼中，基线或随访期间存在VMT的患眼（n = 60）平均注射次数为15.4±0.9次，基线或随访期间存在VMA的患眼（n = 79）平均注射次数为13.8±0.7次，无VMT或VMA的患眼（n = 377）平均注射次数为12.9±0.4次（P = 0.02）。此外，按需治疗的患眼在随访期间未观察到VMT时平均注射次数为13.0±0.3次，观察到1次时为13.6±1.3次，观察到不止1次时为17±1.2次。2年时，基线时存在VMT或VMA的患眼中发生地图样萎缩的比例（11.7%）低于两者均无的患眼（22.5%；P = 0.005）。
结论
在CATT研究的患眼中，VMT和VMA并不常见。在基线和随访时，VMT或VMA与视力无关。按需治疗的存在VMT或VMA的患眼在2年期间平均多需要2次注射。
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