Department of Ophthalmology, University Hospital Jean Minjoz of Besançon, Franche-Comté University, 25000 Besançon, France.
Graefes Arch Clin Exp Ophthalmol. 2013 Aug;251(8):1901-7. doi: 10.1007/s00417-013-2284-9. Epub 2013 Feb 22.
The purpose of this study was to analyze the results of a retreatment regimen using a series of three monthly intravitreal ranibizumab injections (IVR), instead of one injection, and to determine if this treatment scheme can safely reduce the number of injections and the number of visits compared to the widely used PrONTO study retreatment protocol.
Sixty-six eyes of 60 patients with exudative age-related macular degeneration (AMD) were included. The mean follow-up period was 27 months (range, 11-48 months). The mean age of the patients was 79 years (range, 65-93 years). All patients received three initial IVRs, and were retreated with a new series of three monthly IVRs when needed. The retreatment criteria were: visual loss of ≥5 ETDRS letters and/or signs of retinal exudation on OCT, new macular hemorrhage, expansion of new vessels. Follow-up visits were conducted 1 month after the last IVR of each series, and renewed on a monthly basis when no retreatment was required. Each visit included a comprehensive ophthalmological examination with BCVA measurement and OCT examination.
Mean VA did not improve during follow-up (53.18 letters at the initial visit versus 54.18 at the last visit, p > 0.05). However, VA stabilized or improved in 66.6 % of the eyes. A gain of ≥15 letters was observed in 28.8 % of eyes. On average, over 2 years, the number of IVRs was five per year, and the number of follow-up visits was four per year.
Even if no gain in VA is observed after 2 years, this treatment regimen reduces the number of IVRs and control visits. The proportion of patients with a VA gain of three lines or more was smaller than the one reported in the original PrONTO study, but higher than the rates reported in other studies implementing the PrONTO recommendations in everyday practice. The benefit of the three IVR retreatment scheme should be prospectively studied and compared to the PRN regimen.
本研究旨在分析采用每月三次玻璃体内雷珠单抗注射（IVR）系列治疗（而非单次注射）的治疗结果，并确定与广泛应用的 PRONTO 研究再治疗方案相比，该治疗方案是否可以安全减少注射次数和就诊次数。
共纳入 60 例渗出性年龄相关性黄斑变性（AMD）患者的 66 只眼。平均随访时间为 27 个月（范围，11-48 个月）。患者平均年龄为 79 岁（范围，65-93 岁）。所有患者均接受了三次初始 IVR，当需要时，再接受新的三次每月 IVR 系列治疗。再治疗标准为：视力损失≥5 ETDRS 字母和/或 OCT 上视网膜渗出的迹象、新的黄斑出血、新血管扩张。在每次系列治疗的最后一次 IVR 后 1 个月进行随访，并在无需再治疗时每月进行随访。每次就诊均包括全面的眼科检查，包括 BCVA 测量和 OCT 检查。
在随访期间，平均视力（VA）并未改善（初始就诊时为 53.18 个字母，最后就诊时为 54.18 个字母，p＞0.05）。然而，66.6%的眼 VA 稳定或改善。28.8%的眼 VA 提高≥15 个字母。平均而言，在 2 年多的时间里，每年接受 5 次 IVR，每年进行 4 次随访。
即使在 2 年后 VA 没有提高，这种治疗方案也可以减少 IVR 和随访次数。VA 提高 3 行或以上的患者比例低于原始 PRONTO 研究报告的比例，但高于其他在日常实践中应用 PRONTO 建议的研究报告的比例。应前瞻性研究并比较三次 IVR 再治疗方案与 PRN 方案的获益。
