Medical Retina Department, Moorfields Eye Hospital, London, UK.
Eye (Lond). 2010 May;24(5):793-8. doi: 10.1038/eye.2009.232. Epub 2009 Sep 25.
To evaluate visual outcomes in patients with neovascular age-related macular degeneration (NV-AMD) who were treated with pegaptanib sodium in European clinical ophthalmology practices.
Thirteen centres in eight European countries participated in this retrospective study. Medical records for patients with any angiographic subtype of subfoveal choroidal neovascularisation secondary to NV-AMD with visual acuities (study eye) of 20/40-20/320 treated with 0.3 mg pegaptanib as first-line treatment and with at least 24 weeks of follow-up were identified. Anonymised data reflecting at least 24 and up to 54 weeks of follow-up were recorded. Primary end points were visual acuity outcomes at weeks 24 and 54 compared with those reported at week 54 in the vascular endothelial growth factor (VEGF) Inhibition Study in Ocular Neovascularisation (VISION) trial.
In all, 253 patients were followed for at least 24 weeks; 62 patients completed 54 weeks of follow-up. A mean of 4.4 (SD, 1.8) pegaptanib injections were administered through 24 weeks. Compared with the VISION trial, the European experience showed that >90% of patients in the current cohort lost <15 letters from baseline at both time points compared with 70% in the VISION trial at 54 weeks. Pegaptanib was well tolerated with no reported cases of endophthalmitis, traumatic cataract, or iatrogenic retinal detachment.
Pegaptanib was found to stabilise vision in a greater percentage of patients and produced greater overall visual improvement in this group of treatment-naive patients with NV-AMD compared with outcomes reported in the VISION trial; however, interpretation of these results should be tempered given the differences in design between this retrospective study and the prospective controlled trial.
评估在欧洲临床眼科实践中接受聚乙二醇化人血管内皮生长因子受体抑制剂（pegaptanib sodium）治疗的新生血管性年龄相关性黄斑变性（NV-AMD）患者的视力结果。
来自欧洲 8 个国家的 13 个中心参与了这项回顾性研究。确定了患有任何血管造影亚型的黄斑下脉络膜新生血管（继发于 NV-AMD）且视力（研究眼）为 20/40-20/320 的患者的医疗记录，这些患者接受了一线治疗 0.3 mg pegaptanib 治疗，并且有至少 24 周的随访。记录了至少 24 周且最多 54 周的随访的匿名数据。主要终点是与 VEGF 抑制研究在眼内新生血管化（VISION）试验中报告的第 54 周相比，第 24 周和第 54 周的视力结果。
总共对 253 名患者进行了至少 24 周的随访；62 名患者完成了 54 周的随访。在 24 周内平均给予 4.4（SD，1.8）次 pegaptanib 注射。与 VISION 试验相比，欧洲的经验表明，与 VISION 试验中 54 周时的 70%相比，目前队列中>90%的患者在这两个时间点从基线丢失的字母数<15。pegaptanib 具有良好的耐受性，没有报道内眼炎、外伤性白内障或医源性视网膜脱离的病例。
与 VISION 试验报告的结果相比，pegaptanib 在该组未经治疗的 NV-AMD 患者中稳定了更多患者的视力，并产生了更大的总体视力改善；然而，鉴于这项回顾性研究和前瞻性对照试验之间的设计差异，应谨慎解释这些结果。
