Retina Division, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland 21287, USA.
Ophthalmology. 2013 Jan;120(1):160-8. doi: 10.1016/j.ophtha.2012.07.027. Epub 2012 Sep 23.
To determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal neovascularization resulting from age-related macular degeneration (AMD).
Phase III, multicenter, randomized clinical trials (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration [MARINA] and Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration [ANCHOR]).
One thousand one hundred twenty-six patients with choroidal neovascularization resulting from AMD.
Participants were assigned randomly to sham (n=238), 0.3-mg ranibizumab monthly injections (n=238), or 0.5-mg ranibizumab monthly injections (n=240) for 24 months (MARINA), or were randomized to verteporfin photodynamic therapy (PDT; n=143), 0.3-mg ranibizumab monthly injections (n=140), or 0.5-mg ranibizumab monthly injections (n=140) for 24 months (ANCHOR).
Self-reported driving status and driving ability perception were assessed as exploratory outcomes at baseline through 24 months after baseline using the 25-item National Eye Institute Visual Function Questionnaire. Best-corrected visual acuity in each eye was assessed monthly through 24 months.
At baseline, 68.6% of patients in the MARINA trial and 62.7% of patients in the ANCHOR trial reported driving. Among patients driving at baseline in the MARINA trial 2 years after randomization, 67.2% (95% confidence interval [CI], 59.2-75.2) of sham patients and 78.4% (95% CI, 71.8-85.0) of 0.5-mg patients reported that they were still driving. Among patients driving at baseline in the ANCHOR trial at 2 years after randomization, 71.6% (95% CI, 60.8-82.4) of PDT patients and 91.4% (95% CI, 85.3-97.5) of 0.5-mg patients were still driving. Also in the ANCHOR trial, ranibizumab-treated patients who were not driving at baseline seemed more likely to drive by months 12 and 24 than PDT patients. Perception of driving ability was correlated with improvement in visual acuity (VA) in the better-seeing eye at 12 and 24 months (R2=0.17 and R2=0.20 at 12 and 24 months, respectively [P<0.001], in the MARINA trial; R2=0.13 and R2=0.14, respectively [P<0.001], in the ANCHOR trial). Visual acuity in one or both eyes 2 years after randomization was more likely to be 20/40 or better in the ranibizumab-treated groups.
These results suggest that patients with neovascular AMD treated with ranibizumab are more likely to report driving ability and have vision of at least 20/40 than patients given sham treatment or PDT.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
评估雷珠单抗对年龄相关性黄斑变性（AMD）脉络膜新生血管患者驾驶状态、驾驶能力感知以及 20/40 或更好视力的影响。
三期、多中心、随机临床试验（MINIMALY CLASSIC/OCCULT 试验，评估抗 VEGF 抗体雷珠单抗治疗新生血管性年龄相关性黄斑变性[MARINA]；抗 VEGF 抗体治疗年龄相关性黄斑变性的主要经典脉络膜新生血管[ANCHOR]）。
1126 例 AMD 脉络膜新生血管患者。
参与者被随机分配至 sham 组（n=238）、每月注射 0.3mg 雷珠单抗组（n=238）或每月注射 0.5mg 雷珠单抗组（n=240），治疗 24 个月（MARINA）；或随机分配至维替泊芬光动力疗法（PDT；n=143）、每月注射 0.3mg 雷珠单抗组（n=140）或每月注射 0.5mg 雷珠单抗组（n=140），治疗 24 个月（ANCHOR）。
在基线和基线后 24 个月，使用 25 项国家眼科研究所视觉功能问卷，评估自我报告的驾驶状态和驾驶能力感知，作为探索性结局。每月评估每只眼的最佳矫正视力，持续 24 个月。
MARINA 试验中，基线时 68.6%的患者和 ANCHOR 试验中 62.7%的患者报告在驾驶。在 MARINA 试验中，随机分组 2 年后仍在驾驶的基线时驾驶患者中，sham 组 67.2%（95%置信区间[CI]，59.2-75.2）和 0.5mg 组 78.4%（95% CI，71.8-85.0）报告仍在驾驶。在 ANCHOR 试验中，随机分组 2 年后仍在驾驶的基线时驾驶患者中，PDT 组 71.6%（95% CI，60.8-82.4）和 0.5mg 组 91.4%（95% CI，85.3-97.5）报告仍在驾驶。同样在 ANCHOR 试验中，与 PDT 患者相比，基线时不驾驶的雷珠单抗治疗患者在第 12 和 24 个月时似乎更有可能驾驶。在第 12 和 24 个月时，更好视力眼的视力改善与驾驶能力感知相关（MARINA 试验中，R2=0.17 和 R2=0.20；ANCHOR 试验中，R2=0.13 和 R2=0.14；均 P<0.001）。随机分组 2 年后，一只或两只眼的视力更有可能达到 20/40 或更好。
这些结果表明，与 sham 治疗或 PDT 相比，接受雷珠单抗治疗的脉络膜新生血管性 AMD 患者更有可能报告驾驶能力，并具有至少 20/40 的视力。
参考文献后可能有专有或商业披露。
