Chong Teo Kelvin Yi, Squirrell David M, Nguyen Vuong, Banerjee Gayatri, Cohn Amy, Barthelmes Daniel, Gemmy Cheung Chui Ming, Gillies Mark
Medical Retina Department, Singapore National Eye Centre, Singapore, Republic of Singapore; Singapore Eye Research Institute, Singapore, Republic of Singapore; Sydney Eye Hospital Foundation, Sydney Eye Hospital, Sydney, Australia.
Department of Ophthalmology, University of Auckland, Auckland, New Zealand.
Ophthalmol Retina. 2019 Mar;3(3):220-229. doi: 10.1016/j.oret.2018.11.003. Epub 2018 Nov 15.
To compare the 12-month real-world visual and disease activity outcomes of eyes with polypoidal choroidal vasculopathy (PCV) treated with a combination of photodynamic therapy (PDT) and anti-vascular endothelial growth factor (VEGF) injections (combination group) versus those eyes treated with anti-VEGF monotherapy alone with rescue PDT being used as required (monotherapy group).
Database comparative observational study.
Eyes with PCV as graded in the Fight Retinal Blindness! database from Australia, New Zealand, Singapore, and Switzerland.
Clinical information from a multisite, international registry of neovascular age-related macular degeneration was analyzed with an intention-to-treat approach.
Primary outcome measure was the change in visual acuity in logMAR letters over 12 months between the two groups analyzed with intention-to-treat approach.
Forty-one and 152 eyes received combination therapy and anti-VEGF monotherapy, respectively. All anti-VEGF agents were pooled, and bevacizumab represented 66.1% of injections administered. The adjusted mean change in visual acuity between the combination group and monotherapy group at 12 months was +16.9 letters (95% confidence interval [CI], 10.6-23.3 letters) and +8.2 letters (95% CI, 5.2-11.3 letters), respectively (P = 0.02). Proportion of inactive lesions and mean time to inactivity was 85.3% and 80.7 days (95% CI, 62.8-98.5 days), respectively, in the combination group compared with 76.8% and 150.4 days (95% CI, 132.8-168.0 days), respectively, in the monotherapy group (P = 0.01). The mean number of injections of anti-VEGF agent between the combination and monotherapy groups was 4.3 injections (95% CI, 3.6-5.2 injections) and 6.4 injections (95% CI, 5.9-6.9 injections), respectively (P = 0.01).
The real-world outcomes for treatment of PCV showed larger gains in vision, higher proportion of inactive lesions, quicker time to inactivity, and fewer injections administered in the combination group compared with the monotherapy group. These findings are consistent with current evidence reporting the advantages of combination therapy for PCV.
比较接受光动力疗法（PDT）联合抗血管内皮生长因子（VEGF）注射治疗的息肉状脉络膜血管病变（PCV）患眼（联合治疗组）与仅接受抗VEGF单药治疗并根据需要使用挽救性PDT的患眼（单药治疗组）12个月的真实世界视力和疾病活动结果。
数据库比较观察性研究。
来自澳大利亚、新西兰、新加坡和瑞士的“抗击视网膜失明！”数据库中分级为PCV的患眼。
采用意向性分析方法分析来自多中心国际新生血管性年龄相关性黄斑变性登记处的临床信息。
主要观察指标是采用意向性分析方法分析的两组之间12个月内logMAR字母视力的变化。
分别有41只和152只患眼接受了联合治疗和抗VEGF单药治疗。所有抗VEGF药物合并计算，贝伐单抗占注射给药的66.1%。联合治疗组和单药治疗组在12个月时调整后的平均视力变化分别为+16.9个字母（95%置信区间[CI]，10.6 - 23.3个字母）和+8.2个字母（95%CI，5.2 - 11.3个字母）（P = 0.02）。联合治疗组无活性病变的比例和无活性的平均时间分别为85.3%和80.7天（95%CI，62.8 - 98.5天），而单药治疗组分别为76.8%和150.4天（9５%CI，132.8 - 168.0天）（P = 0.01）。联合治疗组和单药治疗组抗VEGF药物的平均注射次数分别为4.3次（95%CI，3.6 - 5.2次）和6.4次（95%CI，5.9 - 6.9次）（P = 0.01）。
与单药治疗组相比，PCV治疗的真实世界结果显示联合治疗组在视力改善、无活性病变比例更高、无活性时间更快以及注射次数更少方面更有优势。这些发现与目前报道PCV联合治疗优势的证据一致。
