Comparison of ranibizumab versus dexamethasone for macular oedema following retinal vein occlusion: 1-year results of the COMRADE extension study
Comparison of ranibizumab versus dexamethasone for macular oedema following retinal vein occlusion: 1-year results of the COMRADE extension study
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DOI：
10.1111/aos.13770
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发表时间：
2018-12-01
影响因子：
3.4
通讯作者：
Hoerauf, Hans
中科院分区：
文献类型：
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作者：
Feltgen, Nicolas;Hattenbach, Lars-Olof;Hoerauf, Hans
目的 COMRADE 研究是第一个随机对照头对头试验，比较玻璃体内注射雷珠单抗与地塞米松 (DEX) 对视网膜静脉阻塞 (RVO) 继发黄斑水肿患者的疗效和安全性。 COMRADE 扩展试验旨在提供完成核心研究的患者的额外 6 个月数据。方法 在这项开放标签 IV 期研究中，前瞻性地纳入了完成 COMRADE 核心研究的患者。总体而言，92 名分支 RVO (BRVO) 患者（雷珠单抗 52、DEX 40）和 83 名中枢 RVO (CRVO) 患者（雷珠单抗 61、DEX 22）接受了治疗，94.6% 的 BRVO 患者和 97.6% 的 CRVO 患者完成了延伸研究。患者被分配到与核心研究相同的治疗组。每月对患者进行监测，并根据需要接受 0.5 mg 雷珠单抗或 0.7 mg DEX 植入物。结果 在延长过程中，接受雷珠单抗治疗的 BRVO 患者中有 55.8% 发生了研究眼的治疗相关不良事件 (TEAE)，而接受 DEX 治疗的 BRVO 患者中有 62.5% 发生了治疗相关不良事件 (TEAE)。在 CRVO 患者中，雷珠单抗组和 DEX 组分别有 65.5% 和 59.1% 的患者出现 TEAE。总体而言，DEX 治疗比雷珠单抗治疗更常见眼压 (IOP) 升高。 BRVO 患者最佳矫正视力 (BCVA) 的平均变化明显优于雷珠单抗 (p = 0.0249)。 CRVO 结果与 BRVO 一致，但不显着 (p = 0.1119)。结论 根据欧洲标签使用时，雷珠单抗显示出比 DEX 更好的眼部安全性，并且产生更大的平均 BCVA 增益。在额外的 6 个月研究期结束时，BRVO 患者和 CRVO 患者的 BCVA 差异更为明显。 COMRADE 研究的主要局限性是 DEX 患者在前 6 个月内仅接受了一次玻璃体内治疗，这可能是不够的。然而，频繁植入 DEX 可能会导致更多与类固醇相关的副作用，尤其是眼压升高。
Purpose The COMRADE studies are the first randomized controlled head-to-head trials comparing the efficacy and safety of intravitreal ranibizumab versus dexamethasone (DEX) in patients with macular oedema secondary to retinal vein occlusion (RVO). The COMRADE extension trial was designed to provide additional 6-month data of patients who completed the core studies. Methods In this open-label, phase IV study patients who completed the COMRADE core studies were prospectively enrolled. Overall, 92 branch RVO (BRVO) patients (ranibizumab 52, DEX 40) and 83 central RVO (CRVO) patients (ranibizumab 61, DEX 22) were treated, and 94.6% of BRVO patients and 97.6% of CRVO patients completed the extension study. Patients were assigned to the same treatment group as in the core studies. Patients were monitored monthly and received either 0.5 mg ranibizumab or a 0.7 mg DEX implant as needed. Results Over the course of the extension, treatment-emergent adverse events (TEAEs) of the study eye occurred in 55.8% of BRVO patients on ranibizumab and in 62.5% of those on DEX. Among CRVO patients, 65.5% in the ranibizumab group and 59.1% in the DEX group developed TEAEs. Overall, elevated intraocular pressure (IOP) was more frequent with DEX than ranibizumab treatment. Mean average change in best-corrected visual acuity (BCVA) in BRVO patients was significantly better for ranibizumab than DEX (p = 0.0249). The CRVO results were consistent with BRVO's, although not significant (p = 0.1119). Conclusion When used according to the European labels, ranibizumab revealed a better ocular safety profile and produced greater average BCVA gains than DEX. By the end of the additional 6-month study period, this difference in BCVA was more pronounced in BRVO as in CRVO patients. The main limitation of the COMRADE studies was that DEX patients received only a single intravitreal treatment during the first 6 months, which is presumably not adequate. However, frequent DEX implants could lead to more steroid-related side effects, especially to an increased intraocular pressure.