Quiram Polly A, Hassan Tarek S, Williams George A
Associated Retinal Consultants, Beaumont Hospital, Royal Oak, Michigan 48073, USA.
Retina. 2007 Sep;27(7):851-6. doi: 10.1097/IAE.0b013e31806458f0.
To evaluate the safety and efficacy of pegaptanib sodium injection (Macugen, OSI Eyetech Pharmaceuticals) as primary therapy for previously untreated choroidal neovascular membranes (CNV) associated with wet age-related macular degeneration (AMD).
The authors retrospectively reviewed data of 90 patients with newly diagnosed wet AMD in which pegaptanib was used as primary therapy. Inclusion criteria included CNV of any angiographic subtype and size. Exclusion criteria included any lesion previously treated with photodynamic therapy (PDT), intravitreal triamcinolone, or thermal laser. Outcome measures included pre and post-treatment changes in best-corrected visual acuity, lesion size, lesion angiographic characteristics, and optical coherence tomography (OCT) measurements. Patients were injected every 6 weeks and fluorescein angiography (FA) and OCT imaging were performed after every three injections. Safety assessment was performed by complete ophthalmologic examination pre- and post-injection.
Of the patients undergoing primary treatment with pegaptanib, the lesion characteristics were 80% (72/90) occult, 13% (12/90) minimally classic, and 7% (6/90) predominantly classic. Lesion sizes were 50% (45/90) <or=4 disc areas (DA) and 50% (45/90) >4 DA. The mean follow-up was 9.1 +/- 2 months (range 6-14 months). Gain of >or=3 lines of vision occurred in 20% (18/90) of patients, stabilization of vision (prevention of three lines of vision loss) occurred in 70% (63/90) of patients, and loss of >or=3 lines of vision occurred in 10% (9/90) of patients, resulting in a 90% response rate. In the patients who gained >or=3 lines of vision, the average number of injections was 3.5. One case of endophthalmitis was recognized.
Pegaptanib as primary therapy for naïve CNV lesions offers a 90% rate of improvement or stabilization of vision-outcomes that exceed those reported in the VISION trial.
评估聚乙二醇化 apt 钠注射剂（Macugen，OSI 眼科技制药公司）作为初治湿性年龄相关性黄斑变性（AMD）相关脉络膜新生血管膜（CNV）的一线治疗方法的安全性和有效性。
作者回顾性分析了 90 例新诊断的湿性 AMD 患者的数据，这些患者接受聚乙二醇化 apt 钠作为一线治疗。纳入标准包括任何血管造影亚型和大小的 CNV。排除标准包括先前接受过光动力疗法（PDT）、玻璃体内注射曲安奈德或热激光治疗的任何病变。观察指标包括最佳矫正视力、病变大小、病变血管造影特征和光学相干断层扫描（OCT）测量的治疗前后变化。患者每 6 周注射一次，每三次注射后进行荧光素血管造影（FA）和 OCT 成像。通过注射前后的完整眼科检查进行安全性评估。
在接受聚乙二醇化 apt 钠一线治疗的患者中，病变特征为隐匿性 80%（72/90）、最小经典型 13%（12/90）、主要经典型 7%（6/90）。病变大小为 50%（45/90）≤4 个视盘面积（DA），50%（45/90）＞4 DA。平均随访时间为 9.1±2 个月（范围 6 - 14 个月）。20%（18/90）的患者视力提高≥3 行，70%（63/90）的患者视力稳定（预防视力下降 3 行），10%（9/90）的患者视力下降≥3 行，有效率为 90%。在视力提高≥3 行的患者中，平均注射次数为 3.5 次。确认发生 1 例眼内炎。
聚乙二醇化 apt 钠作为初治 CNV 病变的一线治疗方法，视力改善或稳定率为 90%，疗效超过 VISION 试验报告的结果。
