Department of Ophthalmology, Shiga University of Medical Science, Otsu, Japan.
Department of Medicine, University of Udine, Udine, Italy.
Adv Ther. 2020 May;37(5):2184-2198. doi: 10.1007/s12325-020-01298-x. Epub 2020 Mar 28.
To compare visual outcomes and treatment burden between intravitreally administered aflibercept (IVT-AFL) and ranibizumab (RBZ) treat-and-extend (T&E) regimens in patients with wet age-related macular degeneration (wAMD) at 2 years.
A systematic literature review was carried out in Medline, EMBASE, and CENTRAL in October 2018. Matching-adjusted indirect comparison (MAIC) and/or individual patient data meta-regression was used to connect ALTAIR (assessing IVT-AFL T&E) with other studies, adjusting for between-trial differences in baseline visual acuity and age or baseline visual acuity, age, and polypoidal choroidal vasculopathy (PCV) status. Sensitivity analyses were conducted to test the robustness of the results, including direct MAIC between IVT-AFL T&E (ALTAIR) and RBZ T&E (CANTREAT and TREX-AMD trials).
Six randomized controlled trials (RCTs) (ALTAIR, VIEW 1 and 2, CATT, CANTREAT, and TREX) were included in the analysis. IVT-AFL T&E was assessed in one study, ALTAIR (n = 255), while RBZ T&E was assessed in two trials (n = 327). At 2 years, the median difference (95% credibility interval) between IVT-AFL T&E and RBZ T&E regarding the numbers of Early Treatment Diabetic Retinopathy Study (ETDRS) letters gained was not significant (M1: - 2.29 [- 8.10, 3.58]; M2: - 0.55 [- 6.34, 5.29]). IVT-AFL T&E was associated with significantly fewer injections than RBZ-T&E (M1: - 6.12 [- 7.60, - 4.65]; M2: - 5.93 [- 7.42, - 4.45]). Results of the sensitivity analyses were consistent with the main scenarios.
Patients with wAMD receiving an IVT-AFL T&E regimen achieved and maintained improvement in visual acuity with fewer injections over 2 years compared with RBZ T&E. IVT-AFL T&E may therefore serve as the optimal therapy for wAMD, as it was associated with clinical efficacy and minimized treatment burden.
比较湿性年龄相关性黄斑变性(wAMD)患者接受玻璃体内注射阿柏西普(IVT-AFL)和雷珠单抗(RBZ)治疗并按需治疗(T&E)方案 2 年的视力结果和治疗负担。
于 2018 年 10 月在 Medline、EMBASE 和 CENTRAL 进行系统文献检索。采用匹配调整间接比较(MAIC)和/或个体患者数据荟萃回归来连接 ALTAIR(评估 IVT-AFL T&E)与其他研究,根据基线视力和年龄或基线视力、年龄和息肉样脉络膜血管病变(PCV)状态的试验间差异进行调整。进行敏感性分析以测试结果的稳健性,包括 IVT-AFL T&E(ALTAIR)与 RBZ T&E(CANTREAT 和 TREX-AMD 试验)之间的直接 MAIC。
共纳入 6 项随机对照试验(RCT)(ALTAIR、VIEW1 和 2、CATT、CANTREAT 和 TREX)进行分析。一项研究(ALTAIR,n=255)评估了 IVT-AFL T&E,而两项试验(n=327)评估了 RBZ T&E。在 2 年时,IVT-AFL T&E 和 RBZ T&E 治疗后 ETDRS 字母数增加的中位数差值(95%可信度区间)无统计学意义(M1:-2.29[-8.10,3.58];M2:-0.55[-6.34,5.29])。IVT-AFL T&E 治疗组的注射次数明显少于 RBZ-T&E 治疗组(M1:-6.12[-7.60,-4.65];M2:-5.93[-7.42,-4.45])。敏感性分析结果与主要结果一致。
与 RBZ T&E 相比,接受 IVT-AFL T&E 方案治疗的 wAMD 患者在 2 年内视力得到改善并维持,注射次数减少。因此,IVT-AFL T&E 可能成为 wAMD 的最佳治疗选择,因为它具有临床疗效并最大限度地减少了治疗负担。