Retina Division, Wilmer Eye Institute, Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-0005, USA.
Ophthalmology. 2010 Apr;117(4):747-56.e4. doi: 10.1016/j.ophtha.2009.09.002. Epub 2010 Mar 2.
To examine the effects of ranibizumab on the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) scores in neovascular age-related macular degeneration (AMD) according to whether the study eye was the better- or worse-seeing eye at baseline.
Within 2 randomized, double-masked clinical trials (MARINA and ANCHOR), the NEI VFQ-25 was administered at 0, 1, 2, 3, 6, 9, 12, 18, and 24 months.
We included 646 MARINA and 379 ANCHOR patients.
Patients were randomized 1:1:1 to monthly intravitreal ranibizumab (0.3 or 0.5 mg) or control (sham injections for MARINA; photodynamic therapy [PDT] with verteporfin for ANCHOR).
Mean change from baseline in NEI VFQ-25 scores at 12 and 24 months.
Across all treatment arms, 21% to 38% of enrolled eyes were the better-seeing eye. At the 24-month follow-up visit, mean change in composite scores with ranibizumab seemed to be better than control for both better-seeing eyes (8.4 [95% confidence interval (CI), 5.2-11.6], 7.5 [95% CI, 3.7-11.4], and -9.4 [95% CI, -12.5 to -6.3] for the 0.3-mg, 0.5-mg, and sham groups, respectively) and worse-seeing eyes (1.7 [95% CI, -1.1 to 4.4], 1.7 [95% CI, -0.7 to 4.1], and -5.4 [95% CI, -7.9 to -2.8] for the 0.3-mg, 0.5-mg, and sham groups, respectively) in MARINA, as well as the better-seeing eye in ANCHOR (11.3 [95% CI, 5.3-17.3], 13.3 [95% CI, 7.7-19.0], and -2.7 [95% CI, -9.0 to 3.7] for the 0.3-mg, 0.5-mg, and PDT groups, respectively). When the worse-seeing eye was treated in ANCHOR, such differences could not be detected at 24 months (1.3 [95% CI, -1.7 to 4.2], 2.6 [95% CI, -1.1 to 6.3], and 0.1 [95% CI, -3.5 to 3.7] for the 0.3-mg, 0.5-mg, and PDT groups, respectively).
Analysis of patient perception of vision-related function in phase III trials evaluating ranibizumab for neovascular AMD demonstrates improved patient-reported outcomes regardless of whether the treated eye is the better- or worse-seeing eye at onset of treatment, and supports treatment of such lesions with ranibizumab, even those in the worse-seeing eye.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
根据研究眼在基线时是较好眼还是较差眼，评估雷珠单抗对新生血管性年龄相关性黄斑变性（AMD）患者的国家眼科研究所视觉功能问卷-25 （NEI VFQ-25）评分的影响。
在 2 项随机、双盲临床试验（MARINA 和 ANCHOR）中，在 0、1、2、3、6、9、12、18 和 24 个月时进行 NEI VFQ-25 评估。
我们纳入了 646 例 MARINA 和 379 例 ANCHOR 患者。
患者以 1:1:1 的比例随机分配至每月接受玻璃体腔内雷珠单抗（0.3 或 0.5mg）或对照治疗（MARINA 为假注射；ANCHOR 为光动力疗法[PDT]联合维替泊芬）。
在 12 个月和 24 个月时，NEI VFQ-25 评分与基线相比的平均变化。
在所有治疗组中，21%至 38%的入组眼为较好眼。在 24 个月的随访中，与对照组相比，雷珠单抗治疗的复合评分似乎对较好眼和较差眼均有改善（0.3mg、0.5mg 和假注射组的较好眼分别为 8.4[95%置信区间（CI），5.2-11.6]、7.5[95%CI，3.7-11.4]和-9.4[95%CI，-12.5 至-6.3]），较差眼分别为 1.7[95%CI，-1.1 至 4.4]、1.7[95%CI，-0.7 至 4.1]和-5.4[95%CI，-7.9 至-2.8]）。在 MARINA 中，也对 ANCHOR 的较好眼进行了评估（0.3mg、0.5mg 和 PDT 组的较好眼分别为 11.3[95%CI，5.3-17.3]、13.3[95%CI，7.7-19.0]和-2.7[95%CI，-9.0 至 3.7]）。在 ANCHOR 中，当治疗较差眼时，在 24 个月时无法检测到这种差异（0.3mg、0.5mg 和 PDT 组的较差眼分别为 1.3[95%CI，-1.7 至 4.2]、2.6[95%CI，-1.1 至 6.3]和 0.1[95%CI，-3.5 至 3.7]）。
在评估雷珠单抗治疗新生血管性 AMD 的 III 期临床试验中，对患者视觉相关功能的分析表明，无论治疗开始时的研究眼是较好眼还是较差眼，患者报告的结果都有所改善，这支持了用雷珠单抗治疗此类病变，甚至是较差眼的病变。
在参考文献之后可以找到专有或商业披露信息。
