Abedi Farshad, Wickremasinghe Sanjeewa, Islam Amirul F M, Inglis Kellie M, Guymer Robyn H
Center for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Victoria, Australia.
Retina. 2014 Aug;34(8):1531-8. doi: 10.1097/IAE.0000000000000134.
To evaluate 2-year visual acuity outcome of a treat-and-extend protocol of anti-vascular endothelial growth factor treatment in age-related macular degeneration.
In this prospective cohort study, 120 age-related macular degeneration patients with choroidal neovascularization received 3 initial monthly ranibizumab or bevacizumab injections; monthly injections were continued until there was no choroidal neovascularization activity (subretinal/intraretinal fluid, loss of >5 letters, or persistent/recurrent retinal hemorrhage). When there was no choroidal neovascularization activity, the interval to the next visit/injection was extended by 2 weeks to a maximum of 12 weeks. In the presence of choroidal neovascularization activity, this interval was shortened by 2 weeks. Main outcome measures included the percentage losing <15 letters and the mean visual acuity change after 12 months and 24 months.
Mean baseline visual acuity was 51.2 ± 12.1 Early Treatment Diabetic Retinopathy Study scores. Mean visual acuity change from baseline was +9.5 ± 10.9 and +8.0 ± 12.9 letters after 12 months and 24 months, respectively, with, on average, 8.6 ± 1.1 visits/injections in the first year and 5.6 ± 2.0 in the second year. After 12 months and 24 months, 97.5% and 95.0% of patients, respectively, lost <15 letters.
The "inject-and-extend" protocol-with fewer injections and visits-delivered outcomes comparable to those of the pivotal clinical trials of monthly ranibizumab.
评估抗血管内皮生长因子治疗的“治疗-延长”方案在年龄相关性黄斑变性中的2年视力结局。
在这项前瞻性队列研究中,120例年龄相关性黄斑变性伴脉络膜新生血管形成的患者接受了3次初始每月一次的雷珠单抗或贝伐单抗注射;每月注射持续进行,直至没有脉络膜新生血管形成活动(视网膜下/视网膜内液、视力下降>5行或持续性/复发性视网膜出血)。当没有脉络膜新生血管形成活动时,下次就诊/注射的间隔延长2周,最长至12周。若存在脉络膜新生血管形成活动,则将此间隔缩短2周。主要结局指标包括视力下降<15行的患者百分比以及12个月和24个月后的平均视力变化。
平均基线视力为51.2±12.1糖尿病视网膜病变早期治疗研究评分。与基线相比,12个月和24个月后的平均视力变化分别为+9.5±10.9和+8.0±12.9行,第一年平均就诊/注射8.6±1.1次,第二年为5.6±2.0次。12个月和24个月后,分别有97.5%和95.0%的患者视力下降<15行。
“注射-延长”方案注射次数和就诊次数较少,但其疗效与雷珠单抗每月注射的关键临床试验相当。