Pigment Epithelial Detachment Followed by Retinal Cystoid Degeneration Leads to Vision Loss in Treatment of Neovascular Age-Related Macular Degeneration
Pigment Epithelial Detachment Followed by Retinal Cystoid Degeneration Leads to Vision Loss in Treatment of Neovascular Age-Related Macular Degeneration
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DOI：
10.1016/j.ophtha.2014.11.017
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发表时间：
2015-04-01
期刊：
影响因子：
13.7
通讯作者：
Simader, Christian
中科院分区：
文献类型：
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作者：
Schmidt-Erfurth, Ursula;Waldstein, Sebastian M.;Simader, Christian
目的：玻璃体内抗血管生成治疗是治疗新生血管性年龄相关性黄斑变性（AMD）的主要突破。光学相干断层扫描（OCT）是主要的诊断工具，但缺乏最佳治疗结果的可靠标准。使用美国食品和药物管理局和欧洲药品管理局批准的物质以及固定和灵活的方案进行了结构/功能相关性的综合分析。设计：对包括189个研究点的前瞻性、随机多中心临床试验进行事后分析。参与者：共有1240例活动性新生血管性AMD患者。方法：受试者接受玻璃体内注射雷尼珠单抗或阿非利塞。采用固定方案48周，然后采用灵活方案至96周。每隔一个月测量一次最佳矫正视力（BCVA），并通过标准化OCT评估视网膜形态学，包括视网膜内囊肿（IRCs）、视网膜下积液（SRF）和色素上皮脱离（PED），表现为宽度>= 400 mm或高度>= 200 μ m。各方案、特征和时间的结果均相关。主要结局指标：所有治疗组的BCVA结果与视网膜病理形态学相关，基于非劣效性。结果：在新生血管性AMD中，只有基线时的IRC和持续到第12周的IRC对BCVA有负面影响。通过治疗干预，渗出性特征如IRC和SRF在74%的眼睛中迅速消退，而PED仅在38%的眼睛中缓慢消退。视网膜形态与视觉功能密切相关，与固定或灵活的治疗方案类型无关。无论使用哪种治疗方案或药物，视网膜内囊肿的BCVA增益均最低。随着从固定到灵活的再生（PRN）方案的转换，进行性视力丧失仅发生在原发性PED组，这是新血管活动的标志，并由神经感觉视网膜中IRC的继发性形成引起。结论：抗血管生成治疗对新生血管性AMD的疗效在很大程度上取决于其形态学特征。PED的视网膜下色素上皮病变似乎是疾病进行性活动的主要指标，而继发性囊样变性是视觉功能最相关的影像学标志物。临床上，PED成为PRN治疗中连续视力丧失的触发因素。(C) 2015年由美国眼科学会发布。
Purpose: Intravitreal antiangiogenic therapy is the major therapeutic breakthrough in neovascular age-related macular degeneration (AMD). Optical coherence tomography (OCT) is the leading diagnostic tool, but solid criteria for optimal therapeutic outcomes are lacking. A comprehensive analysis of structure/function correlations using Food and Drug Administration-and European Medicines Agency-approved substances and fixed and flexible regimens was performed.Design: Post hoc analysis of a prospective, randomized multicenter clinical trial including 189 study sites.Participants: A total of 1240 patients with active neovascular AMD.Methods: Participants received intravitreal ranibizumab or aflibercept. A fixed regimen was used for 48 weeks followed by a flexible regimen until week 96. At monthly intervals, best-corrected visual acuity (BCVA) was measured and retinal morphology was assessed by standardized OCT, including intraretinal cysts (IRCs), subretinal fluid (SRF), and pigment epithelial detachment (PED), presenting with a width >= 400 mm or a height of >= 200 mu m. Results were correlated for each regimen, feature, and time.Main Outcome Measures: The BCVA outcomes in relation to retinal pathomorphology based on non-inferiority for all treatment arms.Results: In neovascular AMD, only IRC at baseline and persistent through week 12 had a negative impact on BCVA. With therapeutic intervention, exudative features such as IRC and SRF resolved rapidly in 74% of eyes, whereas PED responded only slowly with 38%. Independent of the type of regimen, fixed or flexible, retinal morphology correlated tightly with visual function. Intraretinal cysts consistently showed the lowest BCVA gains with either regimen or substance. With the switch from a fixed to a flexible pro re nata (PRN) regimen, progressive visual loss occurred exclusively in the group with primary PED presenting as the hallmark of neovascular activity and was induced by secondary formation of IRC in the neurosensory retina.Conclusions: The efficacy of antiangiogenic therapy in neovascular AMD is strongly determined by morphologic features. The subretinal pigment epithelium lesion underlying PED appears to be the primary indicator for progressive disease activity, whereas secondary cystoid degeneration is the most relevant imaging marker for visual function. Clinically, PED emerged as trigger for consecutive vision loss in PRN treatment. (C) 2015 by the American Academy of Ophthalmology.