Christian Doppler Laboratory for Ophthalmic Image Analysis, Vienna Reading Center, Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.
Eye Clinic, Department of Clinical Science "Luigi Sacco"- Sacco Hospital, II School of Ophthalmology, University of Milan, Milan, Italy.
Ophthalmology. 2016 Jul;123(7):1521-9. doi: 10.1016/j.ophtha.2016.03.037. Epub 2016 May 4.
To compare the efficacy of intravitreal aflibercept and ranibizumab on the exudative activity of neovascular age-related macular degeneration (nAMD) using optical coherence tomography (OCT) and to correlate morphologic findings with visual acuity (VA) outcomes.
Post hoc analysis of the prospective VIEW trials.
Data of 1815 patients randomized to 0.5 mg ranibizumab every 4 weeks (Q4wks), 2 mg aflibercept Q4wks, or 2 mg aflibercept every 8 weeks (Q8wks).
Standardized OCT evaluation was performed by masked reading centers for the presence of intraretinal cystoid fluid (IRC), subretinal fluid (SRF), and pigment epithelial detachment (PED). Rates of feature resolution were compared between drugs and regimen. Associations between morphologic features and VA were analyzed using multivariate modeling.
Resolution rates of IRC, SRF, and PED, and associations between morphology and VA.
At baseline, the proportions of eyes with IRC, SRF, and PED were balanced between the aflibercept and ranibizumab groups. At week 12, IRC resolved in 50% of eyes with both agents. Subretinal fluid resolved in 70% of pooled aflibercept-treated eyes and in 59% of ranibizumab-treated eyes, and PED resolved in 29% and 24% of pooled aflibercept-treated eyes and ranibizumab-treated eyes, respectively. At week 52, IRC resolved in 57% (aflibercept Q4wks), 50% (aflibercept Q8wks), and 52% (ranibizumab) of patients; SRF resolved in 75% (both aflibercept Q4wks/Q8wks) and 66% (ranibizumab) of patients; and PED resolved in 40% (aflibercept Q4wks), 34% (aflibercept Q8wks), and 28% (ranibizumab) of patients. During fixed dosing (weeks 12-52) all exudative features showed synchronized fluctuations after treatment-free visits in the Q8wks aflibercept regimen. During pro re nata dosing (weeks 52-96), greater proportions of patients showed recurrent fluid in all treatment arms. Presence of IRC was generally associated with lower VA at baseline, which translated into poorer final VA outcomes.
Fluid resolution in all compartments was consistently greater for aflibercept Q4wks than for aflibercept Q8wks and ranibizumab. At week 52, Q8wks aflibercept-treated eyes were, on average, as dry as or drier than with ranibizumab despite the extended treatment interval. Independent of agent or regimen, preexisting morphologic features of the retina at baseline markedly influenced VA outcomes.
利用光学相干断层扫描(OCT)比较玻璃体内注射阿柏西普和雷珠单抗对新生血管性年龄相关性黄斑变性(nAMD)渗出活动的疗效,并将形态学发现与视力(VA)结果相关联。
前瞻性 VIEW 试验的事后分析。
1815 名患者的数据被随机分配至 0.5mg 雷珠单抗每 4 周(Q4wks)、2mg 阿柏西普 Q4wks 或 2mg 阿柏西普每 8 周(Q8wks)。
由盲法阅读中心进行标准化 OCT 评估,以评估视网膜内液(IRC)、视网膜下液(SRF)和色素上皮脱离(PED)的存在。比较药物和方案之间特征分辨率的差异。使用多元建模分析形态特征与 VA 之间的关系。
IRC、SRF 和 PED 的分辨率率,以及形态与 VA 之间的关联。
在基线时,IRC、SRF 和 PED 在阿柏西普和雷珠单抗组之间的比例平衡。在第 12 周时,两种药物治疗后 IRC 均有 50%的缓解。汇集的阿柏西普治疗眼的 SRF 缓解率为 70%,雷珠单抗治疗眼为 59%,汇集的阿柏西普治疗眼和雷珠单抗治疗眼的 PED 缓解率分别为 29%和 24%。在第 52 周时,IRC 缓解率分别为 57%(阿柏西普 Q4wks)、50%(阿柏西普 Q8wks)和 52%(雷珠单抗)的患者;SRF 缓解率分别为 75%(阿柏西普 Q4wks/Q8wks)和 66%(雷珠单抗)的患者;PED 缓解率分别为 40%(阿柏西普 Q4wks)、34%(阿柏西普 Q8wks)和 28%(雷珠单抗)的患者。在固定剂量(第 12-52 周)期间,在 Q8wks 阿柏西普治疗方案的无治疗期后,所有渗出性特征均表现出同步波动。在按需治疗(第 52-96 周)期间,所有治疗组中,更多的患者出现复发性积液。IRC 的存在通常与基线时 VA 较低相关,这导致最终 VA 结果较差。
与阿柏西普 Q8wks 和雷珠单抗相比,阿柏西普 Q4wks 治疗的所有眼的积液消退始终更显著。在第 52 周时,尽管治疗间隔延长,但 Q8wks 阿柏西普治疗的眼平均与雷珠单抗一样干燥或更干燥。无论药物或方案如何,基线时视网膜的预先存在的形态特征对 VA 结果有显著影响。