Ehlken Christoph, Böhringer Daniel, Agostini Hansjürgen T, Grundel Bastian, Stech Milena
Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Department of Ophthalmology, University Hospital Schleswig-Holstein, Kiel, Germany.
Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):105-111. doi: 10.1007/s00417-017-3849-9. Epub 2017 Nov 22.
Stereotactic radiotherapy (SRT, IRay) was able to reduce the need for intravitreal injections of anti-VEGF (IVI) in patients with neovascular AMD (nAMD) in a phase II randomized clinical trial. Certain morphologic characteristics, such as lesion size < 4 mm or lack of fibrosis, were associated with a better response. The purpose of this cross-sectional study was to investigate eligibility for SRT in a clinical routine setting and to compare clinical features of eligible and non-eligible patients.
Cross-sectional study of 468 patients treated for nAMD in one study center within a period of 4 months. Clinical features, such as visual acuity or number of IVI since diagnosis and within 6/12 months, as well as the presence for exclusion criteria for SRT were analyzed. Exclusion criteria were sub-divided into lesion-associated (relevant fibrosis, lesion size > 4 mm, PE tear), ocular comorbidity (e.g., macular comorbidity, vascular disease) and systemic comorbidity (e.g., dementia or tremor).
Exclusion criteria were met by 255 patients (54.5%). Exclusion was most dominantly associated with lesion-associated criteria (80.0%) and less often with ocular (20.8%) or systemic (9.4%) comorbidity. A total of 213 patients (45.5%) fulfilled eligibility criteria. Eligible patients had a better VA at time of analysis (0.36 vs. 0.56 logMAR, p < 0.0001) and at baseline (0.38 vs. 0.56 logMAR, p < 0.0001) compared to non-eligible patients. The numbers of previous intravitreal injections since diagnosis in strictly PRN-treated patients served as a surrogate marker for lesion activity and was comparable within the last 6/12 months. Non-eligible patients had a higher number of different anti-VEGF drugs (1.8 vs. 1.6, p = 0.038).
SRT in addition to anti-VEGF can be an option in every second patient with nAMD. Due to morphological exclusion criteria, patients eligible for SRT had a better VA and a better clinical response compared to non-eligible patients.
在一项II期随机临床试验中,立体定向放射治疗(SRT,iRay)能够减少新生血管性年龄相关性黄斑变性(nAMD)患者玻璃体内注射抗血管内皮生长因子(IVI)的需求。某些形态学特征,如病变大小<4mm或无纤维化,与更好的反应相关。这项横断面研究的目的是调查临床常规环境下SRT的适用性,并比较符合条件和不符合条件患者的临床特征。
对在一个研究中心4个月内接受nAMD治疗的468例患者进行横断面研究。分析了临床特征,如诊断以来及6/12个月内的视力或IVI次数,以及SRT的排除标准。排除标准分为病变相关(相关纤维化、病变大小>4mm、PE撕裂)、眼部合并症(如黄斑合并症、血管疾病)和全身合并症(如痴呆或震颤)。
255例患者(54.5%)符合排除标准。排除主要与病变相关标准(80.0%)相关,与眼部(20.8%)或全身(9.4%)合并症相关的情况较少。共有213例患者(45.5%)符合入选标准。与不符合条件的患者相比,符合条件的患者在分析时(0.