Singapore Eye Research Institute and Singapore National Eye Centre, Singapore; Duke-National University of Singapore Medical School, National University of Singapore, Singapore.
Department of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Am J Ophthalmol. 2019 Aug;204:80-89. doi: 10.1016/j.ajo.2019.02.027. Epub 2019 Mar 6.
We sought to evaluate longer-term efficacy and safety of intravitreal aflibercept monotherapy (IAI) vs IAI plus rescue photodynamic therapy (rPDT) in patients with polypoidal choroidal vasculopathy (PCV).
This was a prospective multicenter, double-masked, sham-controlled randomized clinical study across 62 centers.
In this phase 3b/4 study, patients with PCV with best-corrected visual acuity of 73-24 Early Treatment Diabetic Retinopathy Study letters (20/40-20/320 Snellen equivalent) received IAI 2 mg every 4 weeks until week 12, when they were randomized 1:1 to receive IAI or IAI plus rPDT if rescue criteria were met. Patients not requiring rescue received IAI every 8 weeks; those requiring rescue received IAI every 4 weeks plus sham/active PDT. At week 52 (the primary endpoint), IAI was noninferior to IAI plus rPDT. After week 52, treatment intervals could be extended beyond 8 weeks at the investigators' discretion. Noninferiority of IAI vs IAI plus rPDT for mean best-corrected visual acuity change from baseline to week 96 was evaluated.
Over 96 weeks, 54 patients (17.0%) met rescue criteria. At week 96, IAI was noninferior to IAI plus rPDT in terms of Early Treatment Diabetic Retinopathy Study letters gained (+10.7 vs +9.1, P = .48). Proportions of patients with complete polyp regression (33.1% vs 29.1%) or without active polyps (82.1% vs 85.6%) were similar. In year 2, the mean number of injections was 4.6 in both arms. No new safety signals were observed.
IAI monotherapy was noninferior to IAI with rescue PDT up to 96 weeks, and functional and anatomical improvements achieved at 52 weeks were maintained. Few patients required rescue PDT, which provided no additional visual benefit.
我们旨在评估玻璃体内阿柏西普单药治疗（IAI）与 IAI 联合挽救性光动力疗法（rPDT）治疗息肉状脉络膜血管病变（PCV）患者的长期疗效和安全性。
这是一项在 62 个中心进行的前瞻性、多中心、双盲、假对照随机临床试验。
在这项 3b/4 期研究中，视力最佳矫正视力为 73-24 早期治疗糖尿病视网膜病变研究字母（20/40-20/320 斯耐伦等效）的 PCV 患者接受每 4 周注射 2mg 的 IAI，直至第 12 周，此时根据是否符合挽救标准将患者以 1:1 的比例随机分配至接受 IAI 或 IAI 联合 rPDT。不需要挽救治疗的患者每 8 周接受一次 IAI；需要挽救治疗的患者每 4 周接受一次 IAI 联合假/活性 PDT。在第 52 周（主要终点），IAI 不劣于 IAI 联合 rPDT。第 52 周后，可根据研究者的判断将治疗间隔延长至超过 8 周。评估从基线到第 96 周时 IAI 平均最佳矫正视力变化相对于 IAI 联合 rPDT 的非劣效性。
在 96 周的时间里，有 54 名患者（17.0%）符合挽救标准。在第 96 周，IAI 在获得的早期治疗糖尿病视网膜病变研究字母方面不劣于 IAI 联合 rPDT（+10.7 对+9.1，P=.48）。完全消退息肉的患者比例（33.1%对 29.1%）或无活动息肉的患者比例（82.1%对 85.6%）相似。在第 2 年，两个治疗组的平均注射次数均为 4.6 次。未观察到新的安全性信号。
IAI 单药治疗不劣于 IAI 联合挽救性 PDT 治疗，可达 96 周，并且在第 52 周时获得的功能和解剖学改善得以维持。少数患者需要挽救性 PDT，但并未提供额外的视力获益。
