Incidence of Choroidal Neovascularization in the Fellow Eye in the Comparison of Age-related Macular Degeneration Treatments Trials
Incidence of Choroidal Neovascularization in the Fellow Eye in the Comparison of Age-related Macular Degeneration Treatments Trials
复制标题
DOI：
10.1016/j.ophtha.2013.03.017
复制
发表时间：
2013-10-01
期刊：
影响因子：
13.7
通讯作者：
Martin, Daniel F.
中科院分区：
文献类型：
--
作者：
Maguire, Maureen G.;Daniel, Ebenezer;Martin, Daniel F.
目的：评估药物、给药方案、传统、非传统和遗传风险因素对接受雷珠单抗或贝伐单抗治疗的脉络膜新生血管（CNV）患者对侧眼CNV发生率的影响。设计：多中心随机临床试验患者队列研究。参与者：在入选视网膜相关黄斑变性治疗比较试验（CATT）时，对侧眼无CNV的患者。临床试验的合格标准要求研究眼具有继发于年龄相关性黄斑变性（AMD）的CNV的荧光素血管造影和光学相干断层扫描的证据，并且视力在20/25和20/320之间。研究眼的治疗随机分配为雷珠单抗或贝伐单抗，并在2年内分配为3种不同的给药方案。确定与AMD风险相关的4个单核苷酸多态性（SNPs）基因型。只有基线时对侧眼无CNV的患者才被视为有风险。CATT眼科医生检查患者每4周通过2 years和记录治疗CNV在fellow eye.Main结果措施：发展CNV在fellow eye.Results：在1185 CATT参与者，727（61%）有没有CNV在对侧眼在登记。在2年时，365例接受雷珠单抗治疗的患者中有75例（20.6%）发生CNV，362例接受贝伐单抗治疗的患者中有60例（16.6%）发生CNV（绝对差异，4.0%; 95%置信区间[CI]，-1.7%至9.6%; P = 0.17）。产前给药相对于每月给药的风险比为1.1（95% CI，0.8-1.6）。研究眼中央凹中心视网膜色素上皮和液体的高度升高与对侧眼CNV的发生率增加相关。rs 1061170（CFH）、rs 10490924（ARMS 2）、rs 11200638（HTRA 1）和rs 2230199（C3; P>0.35）基因型与CNV的发生率无关。结论：2年来，雷珠单抗和贝伐单抗在对侧眼CNV的发生率方面无统计学显著差异。先前发现与AMD相关的4个SNP的基因型不影响CATT患者对侧眼CNV的风险。
Objective: To assess the influence of drug; dosing regimen; and traditional, nontraditional, and genetic risk factors on the incidence of choroidal neovascularization (CNV) in the fellow eye of patients treated for CNV with ranibizumab or bevacizumab.Design: Cohort study of patients enrolled in a multicenter, randomized clinical trial.Participants: Patients with no CNV in the fellow eye at the time of enrollment in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT).Methods: Eligibility criteria for the clinical trial required that study eyes have evidence on fluorescein angiography and optical coherence tomography of CNV secondary to age-related macular degeneration (AMD) and visual acuity between 20/25 and 20/320. Treatment for the study eye was assigned randomly to either ranibizumab or bevacizumab and to 3 different regimens for dosing over a 2-year period. The genotypes for 4 single nucleotide polymorphisms (SNPs) associated with risk of AMD were determined. Only patients without CNV in the fellow eye at baseline were considered at risk. The CATT ophthalmologists examined patients every 4 weeks through 2 years and recorded treatment for CNV in the fellow eye.Main Outcome Measures: Development of CNV in the fellow eye.Results: Among 1185 CATT participants, 727 (61%) had no CNV in the fellow eye at enrollment. At 2 years, CNV had developed in 75 (20.6%) of 365 patients treated with ranibizumab and in 60 (16.6%) of 362 patients treated with bevacizumab (absolute difference, 4.0%; 95% confidence interval [CI], -1.7% to 9.6%; P = 0.17). The risk ratio for pro re nata dosing relative to monthly dosing was 1.1 (95% CI, 0.8-1.6). Greater elevation of the retinal pigment epithelium and fluid in the foveal center of the study eye were associated with increased incidence of CNV in the fellow eye. Incidence was not associated with genotype on rs1061170 (CFH), rs10490924 (ARMS2), rs11200638 (HTRA1), and rs2230199 (C3; P>0.35).Conclusions: Through 2 years, there was no statistically significant difference between ranibizumab and bevacizumab in incidence of CNV in the fellow eye. Genotype on 4 SNPs previously found to be associated with AMD did not affect the risk of CNV in the fellow eye among CATT patients.