探讨玻璃体内阿柏西普(IVT-AFL)的有效性和安全性,在ALTAIR研究纳入的息肉状脉络膜血管病变(PCV)患者亚组中,针对渗出性年龄相关性黄斑变性(AMD)的个体化治疗和扩展(T&E)方案.
这是ALTAIR的PCV亚组分析,96周,随机化,开放标签,日本未治疗渗出性AMD患者的4期研究。在三个最初的每月剂量之后,患者在第16周接受IVT-AFL治疗,并以1:1的比例随机分配至T&E治疗方案,并进行2周(IVT-AFL-2W)或4周(IVT-AFL-4W)调整.ALTAIR的主要终点是最佳矫正视力(BCVA)从基线到第52周的平均变化。在第52周和第96周评估终点。进行了安全性分析。
共有90例PCV患者被纳入完整的分析集。从基线到第52周,IVT-AFL-2W和IVT-AFL-4W组中BCVA的平均[标准偏差(SD)]变化为7.5(14.7)个字母和8.2(11.6)个字母,分别。从基线到第96周,IVT-AFL-2W和IVT-AFL-4W组中分别有91.3%和90.9%的患者保持了视力,分别。从基线到第52周,IVT-AFL-2W和IVT-AFL-4W组中央视网膜厚度的平均(SD)变化为-153(177)µm和-112(122)µm,分别。总的来说,51.1%的患者(IVT-AFL-2W,43.5%;IVT-AFL-4W,59.1%)在第16周和第96周之间实现了16周的治疗间隔。IVT-AFL的安全性与以前的研究一致。
在未治疗的PCV患者中,使用两种不同的T&E方案进行的IVT-AFL在96周内改善并维持了功能和解剖结果,同时最大程度地减少了治疗负担。
ClinicalTrials.gov标识符,NCT02305238。
To explore the efficacy and safety of intravitreal aflibercept (IVT-AFL) proactive, individualized treat-and-extend (T&E) regimens in exudative age-related macular degeneration (AMD) in the subgroup of patients with polypoidal choroidal vasculopathy (PCV) enrolled in the ALTAIR study.
This was a PCV subgroup analysis of ALTAIR, a 96-week, randomized, open-label, phase 4 study in treatment-naïve patients with exudative AMD in Japan. Following three initial monthly doses, patients received IVT-AFL at week 16 and were randomized 1:1 to T&E regimens with either 2-week (IVT-AFL-2W) or 4-week (IVT-AFL-4W) adjustments. The primary endpoint of ALTAIR was the mean change in best-corrected visual acuity (BCVA) from baseline to week 52. Endpoints were assessed at weeks 52 and 96. Safety analyses were conducted.
A total of 90 patients with PCV were included within the full analysis set. From baseline to week 52, mean [standard deviation (SD)] change in BCVA was + 7.5 (14.7) letters and + 8.2 (11.6) letters in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. From baseline to week 96, 91.3% and 90.9% of patients maintained vision in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. From baseline to week 52, mean (SD) change in central retinal thickness was - 153 (177) µm and -112 (122) µm in the IVT-AFL-2W and IVT-AFL-4W groups, respectively. Overall, 51.1% of patients (IVT-AFL-2W, 43.5%; IVT-AFL-4W, 59.1%) achieved a treatment interval of 16 weeks between weeks 16 and 96. The safety profile of IVT-AFL was consistent with previous studies.
In treatment-naïve patients with PCV, IVT-AFL administered using two different T&E regimens improved and maintained functional and anatomic outcomes over 96 weeks while minimizing treatment burden.
ClinicalTrials.gov identifier, NCT02305238.