首页> 外文期刊>British journal of ophthalmology >16 Gy low-voltage x-ray irradiation followed by as needed ranibizumab therapy for age-related macular degeneration: 12 month outcomes of a 'radiation-first' strategy
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16 Gy low-voltage x-ray irradiation followed by as needed ranibizumab therapy for age-related macular degeneration: 12 month outcomes of a 'radiation-first' strategy

机译:16 Gy低压X射线照射,然后根据需要接受兰尼单抗治疗以治疗与年龄有关的黄斑变性:“放射至上”策略的12个月结果

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Background and objective: To describe 'radiation-first' combination treatment with a non-invasive, low-voltage x-ray irradiation system followed by as needed ranibizumab for neovascular age-related macular degeneration (AMD). Study design and methods: Phase I study of noninvasive, low-voltage 16 Gy x-ray irradiation delivered in three beams via the inferior pars plana in patients with active neovascular AMD. Ranibizumab was administered as needed per protocol. Patients were followed monthly for safety and efficacy over 12 months. Results: 13 patients were enrolled and completed 12 months follow-up. Safety was good with no serious ocularon-ocular adverse events or radiation-related ocular complications. 11 patients lost <15 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters, seven gained ≥0 ETDRS letters and 0 gained ≥15 ETDRS letters. Patients received a total of 31 subsequent ranibizumab injections (of possible 156) over the 12 months following x-ray irradiation. Mean time to first injection was 3.9 months. One patient received no ranibizumab injections, three patients received one injection, four patients received two injections, and five patients received three or more injections. Conclusions: After 12 months, non-invasive, low-voltage x-ray irradiation with as needed ranibizumab rescue therapy demonstrated good safety with a visual acuity stabilising effect and reduction in retinal thickness in patients with neovascular AMD.
机译:背景与目的:描述用无创,低压x射线照射系统进行“辐射优先”联合治疗,然后根据需要应用兰尼单抗治疗新血管性年龄相关性黄斑变性(AMD)。研究设计和方法:在活动性新生血管性AMD患者中,通过下颌骨通过三束射线进行的无创低压16 Gy x射线辐射的第一阶段研究。根据方案,根据需要施用雷珠单抗。每月对患者进行12个月的安全性和有效性随访。结果:招募了13例患者,并完成了12个月的随访。安全性良好,无严重的眼部/非眼部不良事件或与辐射有关的眼部并发症。 11例<15的糖尿病视网膜病变早期治疗研究患者失去(ETDRS)字母,其中7例获得≥0的ETDRS字母,0例获得≥15的ETDRS字母。在X射线照射后的12个月内,患者总共接受了31次随后的兰尼单抗注射(可能为156次)。首次注射的平均时间为3.9个月。一名患者未接受兰​​尼单抗注射,三名患者接受了一次注射,四名患者接受了两次注射,五名患者接受了三次或更多次注射。结论:12个月后,根据需要使用兰尼单抗抢救疗法进行的非侵入性低压X射线照射显示出良好的安全性,并具有视敏度稳定作用和减少了新生血管AMD患者的视网膜厚度。

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