Improved vision-related function after ranibizumab treatment of Neovascular age-related macular degeneration - Results of a randomized clinical trial
Improved vision-related function after ranibizumab treatment of Neovascular age-related macular degeneration - Results of a randomized clinical trial
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DOI：
10.1001/archopht.125.11.1460
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发表时间：
2007-11-01
影响因子：
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通讯作者：
Klesert, Todd R.
中科院分区：
文献类型：
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作者：
Chang, Tom S.;Bressler, Neil M.;Klesert, Todd R.
目的：应用美国国家眼科学会视觉功能调查表25(NEI VFQ-25)，研究雷尼比珠单抗对新生血管性老年性黄斑变性(AMD)患者视功能的影响。设计：在Marina，一项随机、双盲临床试验，将716例近期疾病进展、无典型或隐匿性、无典型病变成分的AMD患者随机分为1：1：1、每月玻璃体内注射雷比珠单抗(0.3或0.5 mg)或假注射。分别在0、1、2、3、6、9、12、18和24个月进行NEI VFQ-25评分。主要观察指标：12个月和24个月时NEI VFQ-25评分的平均变化。结果：12个月时，接受雷尼比单抗治疗的患者(0.3 mg[n=238]和0.5 mg[n=240])的NEI VFQ-25综合评分的平均改善分别为+5.2(95%可信区间，3.5~6.9)和+5.6(95%可信区间，3.9~7.4)；假注射患者(n=238)的平均下降率为-2.8(95%CI，-4.6至-1.1；P<；0.001vs每个剂量)。在24个月中，接受雷尼比珠纳治疗的患者在近距离活动、远距离活动和视觉依赖性方面更有可能得到改善。结论：在码头，接受雷尼比珠单抗治疗的患者在12个月和24个月时比假治疗患者更有可能报告视觉功能改善。
Objective: To examine the effects of ranibizumab on patient-reported visual function using the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) in patients with neovascular age-related macular degeneration (AMD).Design: In MARINA, a randomized, double-masked clinical trial, 716 patients with AMD with recent disease progression and minimally classic or occult with no classic lesion component were randomized 1: 1: 1 to monthly intravitreal ranibizumab (0.3 or 0.5 mg) or sham injections. The NEI VFQ-25 was administered at 0, 1, 2, 3, 6, 9, 12, 18, and 24 months.Main Outcome Measure: Mean change from baseline in NEI VFQ-25 scores at 12 and 24 months.Result: At 12 months, ranibizumab-treated patients (0.3 mg [n=238] and 0.5 mg [n=240]) had mean improvements in NEI VFQ-25 composite scores of +5.2 (95% confidence interval [CI], 3.5 to 6.9) and +5.6 (95% CI, 3.9 to 7.4), respectively; sham-injected patients (n=238) had a mean decline of -2.8 (95% CI, -4.6 to -1.1; P < .001 vs each dose). Ranibizurnab-treated patients were more likely to improve in near activities, distance activities, an vision-specific dependency through 24 months.Conclusions: In MARINA, ranibizumab-treated patients were more likely than sham-treated patients to report visual function improvements at 12 and 24 months.