Department of Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania.
Department of Ophthalmology, Duke University, Durham, North Carolina.
Ophthalmology. 2014 Mar;121(3):656-66. doi: 10.1016/j.ophtha.2013.10.019. Epub 2013 Dec 4.
To describe risk factors for scar in eyes treated with ranibizumab or bevacizumab for neovascular age-related macular degeneration (AMD).
Prospective cohort study within a randomized clinical trial.
Patients with no scar on color fundus photography (CFP) or fluorescein angiography (FA) at enrollment in the Comparison of Age-related Macular Degeneration Treatments Trials (CATT).
Eyes were assigned to ranibizumab or bevacizumab treatment and to 1 of 3 dosing regimens for 2 years. Masked readers assessed CFP and FA. Baseline demographic characteristics, visual acuity, morphologic features on photography and optical coherence tomography (OCT), and genotypes associated with AMD risk were evaluated as risk factors using adjusted hazard ratios (aHRs) and associated 95% confidence intervals (CIs). Scars were classified as fibrotic with well-demarcated elevated mounds of yellowish white tissue or nonfibrotic with discrete flat areas of hyperpigmentation with varying amounts of central depigmentation.
Scar formation.
Scar developed in 480 of 1059 eyes (45.3%) by 2 years. Baseline characteristics associated with greater risk of scarring were predominantly classic choroidal neovascularization (CNV) (aHR, 3.1; CI, 2.4-3.9) versus occult CNV, blocked fluorescence (aHR, 1.4; CI, 1.1-1.8), foveal retinal thickness >212 μm (aHR, 2.4; CI, 1.7-3.6) versus <120 μm, foveal subretinal tissue complex thickness >275 μm (aHR, 2.4; CI, 1.7-3.6) versus ≤75 μm, foveal subretinal fluid (aHR, 1.5; CI, 1.1-2.0) versus no subretinal fluid, and subretinal hyperreflective material (SHRM) (aHR, 1.7; CI, 1.3-2.3) versus no SHRM. Eyes with elevation of the retinal pigment epithelium had lower risk (aHR, 0.6; CI, 0.5-0.8) versus no elevation. Drug, dosing regimen, and genotype had no statistically significant association with scarring. Fibrotic scars developed in 24.7% of eyes, and nonfibrotic scars developed in 20.6% of eyes. Baseline risk factors for the scar types were similar except that eyes with larger lesion size or visual acuity <20/40 were more likely to develop fibrotic scars.
Approximately half of eyes enrolled in CATT developed scar by 2 years. Eyes with classic neovascularization, a thicker retina, and more fluid or material under the foveal center of the retina are more likely to develop scar.
描述接受雷珠单抗或贝伐单抗治疗的新生血管性年龄相关性黄斑变性（AMD）患者出现瘢痕的风险因素。
一项在随机临床试验中进行的前瞻性队列研究。
无眼底彩色照相术（CFP）或荧光素血管造影术（FA）瘢痕的比较年龄相关性黄斑变性治疗试验（CATT）入组患者。
将眼分为雷珠单抗或贝伐单抗治疗组，并在 2 年内采用 3 种剂量方案中的 1 种进行治疗。有经验的读片者评估 CFP 和 FA。使用调整后的危害比（aHR）和相关的 95%置信区间（CI）评估基线人口统计学特征、视力、摄影和光学相干断层扫描（OCT）形态特征以及与 AMD 风险相关的基因型等作为风险因素。瘢痕分为纤维化，表现为边界清晰的黄色白色组织隆起的瘤状突起，或非纤维化，表现为边界不清晰的离散扁平色素沉着区，伴有不同程度的中心脱色素。
瘢痕形成。
2 年内，1059 只眼中有 480 只（45.3%）出现瘢痕。与瘢痕形成风险增加相关的基线特征主要为典型脉络膜新生血管（CNV）（aHR，3.1；CI，2.4-3.9）而非隐匿性 CNV、荧光阻滞（aHR，1.4；CI，1.1-1.8）、视网膜厚度＞212μm（aHR，2.4；CI，1.7-3.6）而非＜120μm、中心凹下视网膜组织复合体厚度＞275μm（aHR，2.4；CI，1.7-3.6）而非≤75μm、中心凹下视网膜下液（aHR，1.5；CI，1.1-2.0）而非无视网膜下液、以及视网膜下高反射物质（SHRM）（aHR，1.7；CI，1.3-2.3）而非无 SHRM。视网膜色素上皮抬高的眼发生瘢痕的风险较低（aHR，0.6；CI，0.5-0.8）。药物、剂量方案和基因型与瘢痕形成无统计学显著关联。24.7%的眼发生纤维化瘢痕，20.6%的眼发生非纤维化瘢痕。两种瘢痕类型的基线风险因素相似，但病变较大或视力＜20/40的眼更可能发生纤维化瘢痕。
大约一半的 CATT 入组眼在 2 年内出现瘢痕。具有典型新生血管、更厚的视网膜以及更多的中心凹下视网膜下液或物质的眼更易发生瘢痕。
