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ABC 试验中的对比敏感度结果:贝伐单抗治疗新生血管性年龄相关性黄斑变性的随机试验。

Contrast sensitivity outcomes in the ABC Trial: a randomized trial of bevacizumab for neovascular age-related macular degeneration.

机构信息

NIHR Biomedical Research Centre for Ophthalmology, Moorfields Eye Hospital and UCL Institute of Ophthalmology, London, UK.

出版信息

Invest Ophthalmol Vis Sci. 2011 May 11;52(6):3089-93. doi: 10.1167/iovs.10-6208.

Abstract

PURPOSE

To report the impact of intravitreous bevacizumab therapy on contrast sensitivity in patients with neovascular age-related macular degeneration (nAMD).

METHODS

This was a prospective, multicenter, double-masked, randomized, controlled trial of 131 patients with nAMD. The patients with nAMD had received intravitreal bevacizumab (n = 65) or standard therapy (n = 66) in the study eye with a 6-week cycle of assessment. The bevacizumab treatment was 1.25 mg/0.05 mL, given as three initial treatments with further retreatment as needed according to standard retreatment criteria and a 1-year (54-week) follow-up. Contrast sensitivity was determined during the study using a Pelli-Robson chart.

RESULTS

At the week-54 examination, bevacizumab-treated patients were more likely to gain at least 6 letters or more of contrast sensitivity than the patients receiving standard care (23 [35.4%] versus 10 [15.2%], P = 0.009). In addition the bevacizumab-treated patients were less likely to lose 6 or more letters with a better mean letter change at week 54 than the patients receiving standard care (3 [4.6%] versus 14 [21.2%], and +4.0 versus -0.7 letters; P < 0.05 for both comparisons).

CONCLUSIONS

Consistent with the visual acuity outcomes, bevacizumab improved the chances of a clinically relevant gain in contrast sensitivity in the study population. Given the association between contrast sensitivity and visual disability, the beneficial effects of bevacizumab therapy on contrast sensitivity outcomes are expected to have a favorable impact on patients' daily activities. (www.controlled-trials.com number, ISRCTN83325075.).

摘要

目的

报告玻璃体内注射贝伐单抗治疗对年龄相关性黄斑变性(AMD)患者对比敏感度的影响。

方法

这是一项针对 131 例 nAMD 患者的前瞻性、多中心、双盲、随机、对照临床试验。nAMD 患者在研究眼中接受玻璃体内贝伐单抗(n = 65)或标准治疗(n = 66),评估周期为 6 周。贝伐单抗治疗为 1.25mg/0.05ml,根据标准治疗标准,初始治疗 3 次,根据需要进一步治疗,随访 1 年(54 周)。研究期间使用 Pelli-Robson 图表测定对比敏感度。

结果

在第 54 周检查时,与接受标准治疗的患者相比,接受贝伐单抗治疗的患者更有可能获得至少 6 个字母或更多的对比敏感度(23 [35.4%] 与 10 [15.2%],P = 0.009)。此外,与接受标准治疗的患者相比,接受贝伐单抗治疗的患者更不可能失去 6 个或更多字母,在第 54 周时平均字母变化更好(3 [4.6%] 与 14 [21.2%],+4.0 与-0.7 字母;两者比较均 P < 0.05)。

结论

与视力结果一致,贝伐单抗提高了研究人群中对比敏感度获得临床相关改善的机会。鉴于对比敏感度与视觉障碍之间的关联,贝伐单抗治疗对对比敏感度结果的有益影响预计将对患者的日常活动产生有利影响。(www.controlled-trials.com 编号,ISRCTN83325075。)

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