Ying Gui-Shuang, Maguire Maureen G, Pan Wei, Grunwald Juan E, Daniel Ebenezer, Jaffe Glenn J, Toth Cynthia A, Hagstrom Stephanie A, Martin Daniel F
Department of Ophthalmology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
Duke Eye Center, Duke University, Durham, NC.
Ophthalmol Retina. 2018 Jun;2(6):525-530. doi: 10.1016/j.oret.2017.10.003.
To determine baseline predictors of visual acuity (VA) outcomes at 5 years after initiating treatment with ranibizumab or bevacizumab for neovascular age-related macular degeneration (AMD).
Secondary analysis of data from a cohort study.
Patients enrolled in the Comparison of AMD Treatments Trials (CATT) who completed a 5-year follow-up visit.
Participants were randomly assigned to ranibizumab or bevacizumab and to 1 of 3 dosing regimens. After two years, patients were released from the clinical trial protocol, and were recalled for examination at 5 years. Trained readers evaluated baseline lesion features, fluid and thickness. Baseline predictors were determined using univariate and multivariate regression analysis.
VA score and change from baseline, ≥3-line gain, and VA 20/200 or worse at 5 years.
Among 647 patients with VA measured at 5 years, mean VA score in the study eye was 58.9 letters (≈20/63), mean decrease from baseline was 3.3 letters, 17.6% eyes gained ≥3 lines, and 19.9% had VA of 20/200 or worse. In multivariate analysis, worse baseline VA was associated with worse VA, more VA gain, higher percentage with ≥3-line gain, and higher percentage with 20/200 or worse at 5 years (all p<0.001). Larger baseline CNV lesion area was associated with worse VA, greater VA loss, and higher percentage with 20/200 or worse at 5 years (all p<0.05). Absence of baseline subretinal fluid was associated with worse VA (p=0.03) and more VA loss (p=0.03). Female gender, bevacizumab treatment in the first 2 years, and absence of RPE elevation were associated with higher percentage with ≥3-line gain. Cigarette smoking was associated with a higher percentage with 20/200 or worse. None of the 21 SNPs evaluated were associated with VA outcomes.
Five years after initiating treatment with ranibizumab or bevacizumab in CATT participants, worse baseline VA, larger baseline CNV lesion area, and presence of baseline RPE elevation remained independently associated with worse VA at 5 years. In addition, male gender, cigarette smoking, absence of subretinal fluid and treatment with ranibizumab in the first 2 years were independently associated with worse vision outcomes at 5 years.
确定在使用雷珠单抗或贝伐单抗治疗新生血管性年龄相关性黄斑变性(AMD)后5年时视力(VA)结果的基线预测因素。
队列研究数据的二次分析。
参加AMD治疗试验比较(CATT)并完成5年随访的患者。
参与者被随机分配至雷珠单抗或贝伐单抗,并接受三种给药方案中的一种。两年后,患者从临床试验方案中退出,并在5年时被召回进行检查。经过培训的阅片者评估基线病变特征、积液和厚度。使用单变量和多变量回归分析确定基线预测因素。
VA评分及与基线相比的变化、视力提高≥3行、以及5年时VA为20/200或更差。
在647例5年时测量了VA的患者中,研究眼的平均VA评分为58.9个字母(约20/63),与基线相比平均下降3.3个字母,17.6%的眼视力提高≥3行,19.9%的眼VA为20/200或更差。在多变量分析中,较差的基线VA与较差的VA、更多的VA提高、视力提高≥3行的更高百分比以及5年时VA为20/200或更差的更高百分比相关(均p<0.001)。更大的基线脉络膜新生血管(CNV)病变面积与较差的VA、更大的VA损失以及5年时VA为20/200或更差的更高百分比相关(均p<0.05)。基线时无视网膜下液与较差的VA(p=0.03)和更多的VA损失(p=0.03)相关。女性、前2年使用贝伐单抗治疗以及无视网膜色素上皮(RPE)抬高与视力提高≥3行的更高百分比相关。吸烟与VA为20/200或更差的更高百分比相关。评估的21个单核苷酸多态性(SNP)均与VA结果无关。
在CATT参与者中使用雷珠单抗或贝伐单抗治疗5年后,较差的基线VA、更大的基线CNV病变面积以及基线RPE抬高仍然与5年时较差的VA独立相关。此外,男性、吸烟、无视网膜下液以及前2年使用雷珠单抗治疗与5年时较差的视力结果独立相关。