Year 2 efficacy results of 2 randomized controlled clinical trials of pegaptanib for neovascular age-related macular degeneration
Year 2 efficacy results of 2 randomized controlled clinical trials of pegaptanib for neovascular age-related macular degeneration
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DOI：
10.1016/j.ophtha.2006.02.064
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发表时间：
2006-09-01
期刊：
影响因子：
13.7
通讯作者：
Patel, Manju
中科院分区：
文献类型：
--
作者：
Chakravarthy, U.;Adamis, A. P.;Patel, Manju
目的：评价培加他尼钠治疗新生血管性年龄相关性黄斑变性（AMD）患者第二年的疗效。设计：两个并发、多中心、随机、双掩蔽、假对照研究（v.i.s.i.o.n[眼部新生血管中的血管内皮生长因子抑制研究]试验）。参与者：所有血管性黄斑变性的新生血管病变组成的患者被纳入研究。在联合分析中，88%（1053/1190）患者在第54周被重新随机化，89%（941/1053）患者在第102周被评估。干预措施：在第54周，最初分配给pegaptanib的患者被重新随机（1:1）继续或停止治疗48周（8次注射）。最初被分配到假药组的患者被重新随机分配到继续假药组、停止假药组或接受3剂培加他尼中的1剂。主要观察指标：第54周至第102周，视力随时间的平均变化、VA曲线下标准化面积的平均变化以及>= 5字母丧失的患者比例；从基线到第102周，丢失bbb15个字母（应答者）；获得>= 0,>= 2,>= 3条VA线；并发展为法定失明（20/200或更糟）。结果：在综合分析中，与停止治疗或接受常规护理的患者相比，继续服用0.3 mg pegaptanib的患者的平均VA保持不变。在继续服用pegaptanib的患者中，在第54周至第102周期间，从基线下降bbb15个字母的比例是停用pegaptanib或继续接受常规治疗的患者的一半（7%）。Kaplan-Meier分析显示，持续服用0.3 mg pegaptanib 2年的患者比1年后重新随机停药的患者损失>= 15个字母的可能性更小（P < 0.05）。与接受常规治疗的患者相比，接受2年0.3 mg佩加他尼治疗的患者视力恢复的比例更高。持续服用0.3 mg pegaptanib 2年的患者，向法定失明的进展减少。结论：与2年常规治疗或1年停止治疗相比，在vissii.o.n试验的第2年随机接受pegaptanib治疗的患者观察到持续的视力益处。
Objective: To evaluate the efficacy of a second year of pegaptanib sodium therapy in patients with neovascular age-related macular degeneration (AMD).Design: Two concurrent, multicenter, randomized, double-masked, sham-controlled studies (V.I.S.I.O.N. [Vascular Endothelial Growth Factor Inhibition Study in Ocular Neovascularization] trials).Participants: Patients with all angiographic neovascular lesion compositions of AMD were enrolled. In combined analyses, 88% (1053/1190) were re-randomized at week 54, and 89% (941/1053) were assessed at week 102.Interventions: At week 54, those initially assigned to pegaptanib were re-randomized (1:1) to continue or discontinue therapy for 48 more weeks (8 injections). Those initially assigned to sham were re-randomized to continue sham, discontinue sham, or receive 1 of 3 pegaptanib doses.Main Outcome Measures: Mean change in visual acuity (VA) over time and mean change in the standardized area under the curve of VA and proportions of patients experiencing a loss of >= 5 letters from week 54 to week 102; losing > 15 letters (responders) from baseline to week 102; gaining >= 0, >= 2, and >= 3 lines of VA; and progressing to legal blindness (20/200 or worse).Results: In combined analysis, mean VA was maintained in patients continuing with 0.3-mg pegaptanib compared with those discontinuing therapy or receiving usual care. In patients who continued pegaptanib, the proportion who lost > 15 letters from baseline in the period from week 54 to week 102 was half (7%) that of patients who discontinued pegaptanib or remained on usual care (14% for each). Kaplan-Meier analysis showed that patients continuing 0.3-mg pegaptanib for a second year were less likely to lose >= 15 letters than those re-randomized to discontinue after 1 year (P < 0.05). The proportion of patients gaining vision was higher for those assigned to 2 years of 0.3-mg pegaptanib than receiving usual care. Progression to legal blindness was reduced for patients continuing 0.3-mg pegaptanib for 2 years.Conclusions: Continuing visual benefit was observed in patients who were randomized to receive therapy with pegaptanib in year 2 of the V.I.S.I.O.N. trials when compared with 2 years' usual care or cessation of therapy at year 1.