Altaweel Michael M, Daniel Ebenezer, Martin Daniel F, Mittra Robert A, Grunwald Juan E, Lai Michael M, Melamud Alexander, Morse Lawrence S, Huang Jiayan, Ferris Frederick L, Fine Stuart L, Maguire Maureen G
Department of Ophthalmology and Visual Sciences, University of Wisconsin, Madison, Wisconsin.
Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.
Ophthalmology. 2015 Feb;122(2):391-398.e5. doi: 10.1016/j.ophtha.2014.08.020. Epub 2014 Oct 11.
To compare baseline characteristics, treatment frequency, visual acuity (VA), and morphologic outcomes of eyes with >50% of the lesion composed of blood (B50 group) versus all other eyes (Other group) enrolled in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT).
Prospective cohort study within a multicenter randomized clinical trial.
CATT patients with neovascular age-related macular degeneration (AMD).
Treatment for the study eye was assigned randomly to either ranibizumab or bevacizumab and to 3 different dosing regimens over a 2-year period. Reading center graders evaluated baseline and follow-up morphology in color fundus photographs, fluorescein angiography (FA), and optical coherence tomography (OCT). Masked examiners tested VA.
Morphologic features and VA at 1 and 2 years.
The B50 group consisted of 84 of 1185 (7.1%) patients enrolled in CATT. Baseline lesion characteristics differed between groups. In the B50 group, choroidal neovascularization size was smaller (0.73 vs 1.83 disc areas [DA]; P < 0.001), total lesion size was greater (4.55 vs 2.31 DA; P <0.001), total retinal thickness was greater (524 vs 455 μm; P = 0.02), and mean VA was worse (56.0 vs 60.9 letters; P = 0.002). Increases in mean VA were similar in the B50 and Other groups at 1 year (+9.3 vs +7.2 letters; P = 0.22) and at 2 years (9.0 vs 6.1 letters; P = 0.17). Eyes treated PRN received a similar number of injections in the 2 groups (12.2 vs 13.4; P = 0.27). Mean lesion size in the B50 group decreased by 1.2 DA at both 1 and 2 years (primarily owing to resolution of hemorrhage) and increased in the Other group by 0.33 DA at 1 year and 0.91 DA at 2 years (P < 0.001). Leakage on FA and fluid on OCT were similar between groups at 1 and 2 years.
In CATT, the B50 group had a visual prognosis similar to the Other group. Lesion size decreased markedly through 2 years. Eyes like those enrolled in CATT with neovascular AMD lesions composed of >50% blood can be managed similarly to those with less or no blood.
比较年龄相关性黄斑变性治疗试验(CATT)中病变50%以上由血液构成的眼睛(B50组)与所有其他眼睛(其他组)的基线特征、治疗频率、视力(VA)和形态学结果。
多中心随机临床试验中的前瞻性队列研究。
CATT中患有新生血管性年龄相关性黄斑变性(AMD)的患者。
在2年期间,将研究眼的治疗随机分配至雷珠单抗或贝伐单抗,并采用3种不同的给药方案。阅读中心分级人员评估彩色眼底照片、荧光素血管造影(FA)和光学相干断层扫描(OCT)中的基线和随访形态。遮蔽检查人员测试视力。
1年和2年时的形态学特征和视力。
B50组由CATT纳入的1185例患者中的84例(7.1%)组成。两组间基线病变特征不同。在B50组中,脉络膜新生血管大小较小(0.73对1.83视盘面积[DA];P<0.001),总病变大小较大(4.55对2.31 DA;P<0.001),视网膜总厚度较大(524对455μm;P=0.02),平均视力较差(56.0对60.9字母;P=0.002)。B50组和其他组在1年时平均视力增加相似(+9.3对+7.2字母;P=0.22),在2年时也相似(9.0对6.1字母;P=0.17)。按需治疗(PRN)的眼睛在两组中接受的注射次数相似(12.2对13.4;P=0.27)。B50组的平均病变大小在1年和2年时均减少1.2 DA(主要由于出血消退), 其他组在1年时增加0.33 DA,在2年时增加0.91 DA(P<0.001)。两组在1年和2年时FA上的渗漏和OCT上的液体积聚相似。
在CATT中,B50组的视觉预后与其他组相似。病变大小在2年内显著减小。CATT中纳入的新生血管性AMD病变50%以上由血液构成的眼睛,其治疗方式可与血液较少或无血液的眼睛类似。