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雷珠单抗治疗有和无息肉状脉络膜血管病变患者的真实世界疗效和安全性:LUMINOUS 研究的 12 个月结果。

REAL-WORLD EFFECTIVENESS AND SAFETY OF RANIBIZUMAB TREATMENT IN PATIENTS WITH AND WITHOUT POLYPOIDAL CHOROIDAL VASCULOPATHY: Twelve-Month Results From the LUMINOUS Study.

机构信息

Eye and Retina Surgeons, Camden Medical Centre, Singapore, Singapore.

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.

出版信息

Retina. 2020 Aug;40(8):1529-1539. doi: 10.1097/IAE.0000000000002624.

Abstract

PURPOSE

To evaluate the real-world effectiveness and safety of intravitreal ranibizumab 0.5 mg in treatment-naive patients with and without polypoidal choroidal vasculopathy (PCV).

METHODS

Assessment of neovascular age-related macular degeneration patients with or without PCV after 12 months of ranibizumab treatment during the LUMINOUS study. Outcome measures were visual acuity and central retinal thickness changes from baseline and the rate of ocular adverse events.

RESULTS

At baseline, 572 and 5,644 patients were diagnosed with and without PCV, respectively. The mean visual acuity gain from baseline at Month 12 in the PCV and non-PCV groups was +5.0 and +3.0 letters, respectively; these gains were achieved with a mean of 4.4 and 5.1 ranibizumab injections. Eighty percent of PCV patients and 72.2% of non-PCV patients who had baseline visual acuity ≥73 letters maintained this level of vision at Month 12; 20.6% and 17.9% of patients with baseline visual acuity <73 letters achieved visual acuity ≥73 letters in these groups. Greater reductions in central retinal thickness from baseline were also observed for the PCV group versus the non-PCV group. The rate of serious ocular adverse events was 0.7% (PCV group) and 0.9% (non-PCV group).

CONCLUSION

LUMINOUS confirms the effectiveness and safety of ranibizumab in treatment-naive patients with PCV.

摘要

目的

评估玻璃体内雷珠单抗 0.5mg 在未经治疗的伴有和不伴有息肉样脉络膜血管病变(PCV)的患者中的真实世界疗效和安全性。

方法

在 LUMINOUS 研究中,评估接受雷珠单抗治疗 12 个月后的新发性年龄相关性黄斑变性患者是否伴有 PCV。观察指标为从基线开始的视力和中心视网膜厚度变化以及眼部不良事件的发生率。

结果

基线时,分别有 572 例和 5644 例患者被诊断为伴有和不伴有 PCV。PCV 组和非 PCV 组在第 12 个月时从基线开始的平均视力提高分别为+5.0 和+3.0 个字母;这两个组分别使用了 4.4 和 5.1 次雷珠单抗注射来实现这些提高。80%的基线视力≥73 个字母的 PCV 患者和 72.2%的非 PCV 患者在第 12 个月时保持了这一视力水平;基线视力<73 个字母的患者中,20.6%和 17.9%在这两个组中达到了视力≥73 个字母。与非 PCV 组相比,PCV 组的中心视网膜厚度从基线的降低幅度也更大。严重眼部不良事件的发生率为 0.7%(PCV 组)和 0.9%(非 PCV 组)。

结论

LUMINOUS 证实了雷珠单抗在未经治疗的伴有 PCV 的患者中的有效性和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8f00/7392585/49aaded74a57/retina-40-1529-g002.jpg

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