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A 12-month prospective trial of inject and extend regimen for ranibizumab treatment of age-related macular degeneration

机译:兰尼单抗治疗老年性黄斑变性的注射和扩展方案的12个月前瞻性试验

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PURPOSE: To evaluate the safety and efficacy of a strictly applied inject and extend protocol for ranibizumab treatment of age-related macular degeneration. METHODS: This is a prospective, multicenter, nonrandomized trial. Patients underwent standard induction with 3 intravitreal doses of 0.5 mg ranibizumab, each 1 month apart. Following this induction, patients were evaluated and received an injection at each visit. If they did not meet set criteria for signs of exudative disease the interval to the next visit was extended by 2 weeks and if exudative disease was present the interval was shortened by 2 weeks. RESULTS: Vision improved by 1.3 lines (P = 0.008); 26% gained ≥3 lines of vision, 74% lost no lines of vision, and 95% avoided loss of ≥3 lines of vision. CONCLUSION: This study shows that the Inject and Extend protocol is safe and efficacious for the treatment of age-related macular degeneration. Head-to-head studies are needed to compare directly with other regimens currently in use, as well as economic analysis to investigate the financial implications.
机译:目的:评估兰尼单抗治疗年龄相关性黄斑变性的严格应用注射和扩展方案的安全性和有效性。方法:这是一项前瞻性,多中心,非随机试验。患者每隔1个月接受3份0.5毫克雷珠单抗的玻璃体内注射标准诱导。诱导后,对患者进行评估并在每次访视时接受注射。如果他们不符合设定的渗出性疾病迹象标准,则下次就诊的间隔时间延长2周,如果存在渗出性疾病,则间隔时间缩短2周。结果:视力提高了1.3行(P = 0.008); 26%的人获得了≥3视线,74%的人没有丧失视线,95%的人避免了≥3的视线丧失。结论:这项研究表明注射和扩展协议是安全有效的治疗年龄相关性黄斑变性。需要进行直接研究,以与当前使用的其他方案直接进行比较,并需要进行经济分析以调查财务影响。

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