King's College Hospital, London, United Kingdom.
Ophthalmology. 2013 Feb;120(2):328-33. doi: 10.1016/j.ophtha.2012.07.091. Epub 2012 Nov 22.
To report the optical coherence tomography (OCT) and fundus fluorescein angiography (FFA) results of the Macular Epiretinal Brachytherapy in Treated Age-Related Macular Degeneration study.
Prospective, multicenter, interventional, noncontrolled clinical trial.
Fifty-three eyes of 53 participants with chronic, active neovascular age-related macular degeneration (AMD) requiring frequent anti-vascular endothelial growth factor retreatment.
Participants underwent pars plana vitrectomy with a single 24-gray dose of epimacular brachytherapy (EMB), delivered with an intraocular, handheld, cannula containing a strontium 90/yttrium 90 source positioned over the active lesion. Participants were retreated with ranibizumab administered monthly as needed, using predefined retreatment criteria. Patients underwent FFA at baseline, month 1, and month 12. Patients underwent optical coherence tomography (OCT) at baseline and then monthly for 12 months. The FFA and OCT images were evaluated by independent, central reading facilities.
Change in OCT centerpoint thickness and angiographic lesion size 12 months after EMB.
Mean centerpoint thickness increased by 50 μm, from 186 to 236 μm (P = 0.292), but 70% of participants had an increase of less than the mean, with a median increase of only 1.8 μm. The FFA total lesion size increased slightly by 0.79 mm(2), from 14.69 to 15.48 mm(2) (P = 0.710). Total choroidal neovascularization (CNV) area increased by 1.17 mm(2), from 12.94 to 14.12 mm(2) (P = 0.556). The classic CNV area decreased substantially by 3.70 mm(2), from 3.90 to 0.20 mm(2) (P<0.01). Predominantly classic lesions showed the greatest response, with mean Early Treatment Diabetic Retinopathy Study visual acuity improving by 1.5 letters (versus -4.0 for all participants combined); mean centerpoint thickness decreased by 43 μm (P = 0.875). The angiographic and OCT response did not correlate with lesion size at baseline.
In chronic, active, neovascular AMD, EMB is associated with nonsignificant changes in centerpoint thickness and FFA total lesion size over 12 months.
报告黄斑视网膜光凝术治疗年龄相关性黄斑变性的光相干断层扫描（OCT）和眼底荧光血管造影（FFA）结果。
前瞻性、多中心、干预性、非对照临床试验。
53 名患有慢性、活动性新生血管性年龄相关性黄斑变性（AMD）的患者，这些患者需要频繁进行抗血管内皮生长因子治疗。
参与者接受经睫状体平坦部玻璃体切除术，给予 24 格雷的黄斑内照射近距离放射治疗（EMB），使用一种手持、眼内套管，将含有锶 90/钇 90 源的套管放置在活动病变上方。根据预定的再治疗标准，患者每月按需接受雷珠单抗治疗。患者在基线、第 1 个月和第 12 个月接受 FFA。患者在基线和随后的 12 个月内每月接受光学相干断层扫描（OCT）。FFA 和 OCT 图像由独立的中央阅读设施进行评估。
EMB 后 12 个月 OCT 中心厚度和血管造影病变大小的变化。
中心厚度平均值增加了 50μm，从 186μm 增加到 236μm（P=0.292），但 70%的患者增加量低于平均值，中位数仅增加了 1.8μm。FFA 总病变大小略有增加，从 14.69mm2 增加到 15.48mm2（P=0.710）。脉络膜新生血管（CNV）总面积增加了 1.17mm2，从 12.94mm2 增加到 14.12mm2（P=0.556）。经典型 CNV 面积显著减少了 3.70mm2，从 3.90mm2 减少到 0.20mm2（P<0.01）。主要为经典病变的患者反应最大，平均早期治疗糖尿病视网膜病变研究视力提高了 1.5 个字母（与所有参与者的平均视力-4.0 相比）；中心厚度平均减少了 43μm（P=0.875）。血管造影和 OCT 反应与基线时的病变大小无关。
在慢性、活动性、新生血管性 AMD 中，EMB 在 12 个月内与中心厚度和 FFA 总病变大小的无显著变化相关。
