Department of Ophthalmology, Kim's Eye Hospital, Konyang University College of Medicine, #156 Youngdeungpo-dong 4ga, Youngdeungpo-gu, Seoul, 150-034, South Korea.
Graefes Arch Clin Exp Ophthalmol. 2020 Jan;258(1):107-116. doi: 10.1007/s00417-019-04474-0. Epub 2019 Nov 18.
To evaluate the efficacy of intravitreal aflibercept monotherapy for submacular hemorrhage secondary to neovascular age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV).
This prospective, phase 4 clinical trial included 29 patients diagnosed with fovea-involving submacular hemorrhage secondary to neovascular AMD (7 patients) or PCV (22 patients). Patients were initially administered 3 monthly aflibercept injections, followed by 1 injection every 2 months. The primary outcome measure was changes in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) during the 56-week study period. Other key outcome measures were the proportion of patients who exhibited changes in BCVA of ≥ 15 ETDRS letters from baseline and changes in central retinal thickness (CRT).
The mean size of hemorrhage was 6.2 ± 4.8-disc-diameter area. The mean BCVA significantly improved from 52.9 ± 17.8 ETDRS letters at week 0 (baseline) to 71.8 ± 16.1 letters at week 56 (P < 0.001). At week 56, improvement in BCVA of ≥ 15 letters was noted in 16 patients (55.2%), whereas none of the patients experienced a loss of ≥ 15 letters. The mean CRT significantly decreased from 498.9 ± 194.2 μm at week 0 to 248.3 ± 45.0 μm at week 56 (P < 0.001). During the study period, retinal break developed in one patient.
Intravitreal aflibercept administered every 2 months after the 3 initial monthly doses was found to be an effective and safe treatment method for submacular hemorrhage secondary to neovascular AMD.
评估玻璃体内注射阿柏西普单药治疗新生血管性年龄相关性黄斑变性（AMD）和息肉样脉络膜血管病变（PCV）引起的黄斑下出血的疗效。
本前瞻性、4 期临床试验纳入 29 例诊断为黄斑下新生血管性 AMD（7 例）或 PCV（22 例）累及黄斑的患者。患者最初接受 3 次每月阿柏西普注射，随后每 2 个月注射 1 次。主要观察指标为 56 周研究期间最佳矫正视力（BCVA）的早期治疗糖尿病视网膜病变研究（ETDRS）变化。其他关键观察指标包括从基线起 BCVA 变化≥15 个 ETDRS 字母的患者比例和中心视网膜厚度（CRT）变化。
出血平均大小为 6.2±4.8 个视盘直径面积。平均 BCVA 从 0 周（基线）的 52.9±17.8 ETDRS 字母显著提高到 56 周的 71.8±16.1 字母（P<0.001）。在第 56 周时，16 名患者（55.2%）的 BCVA 改善≥15 个字母，而没有患者的 BCVA 损失≥15 个字母。平均 CRT 从 0 周的 498.9±194.2μm显著降低至 56 周的 248.3±45.0μm（P<0.001）。在研究期间，1 名患者出现视网膜裂孔。
在最初 3 次每月剂量后每 2 个月给予玻璃体内注射阿柏西普，对于新生血管性 AMD 引起的黄斑下出血是一种有效且安全的治疗方法。
