Singapore National Eye Centre, Singapore, Singapore.
Singapore Eye Research Institute, Singapore, Singapore.
Acta Ophthalmol. 2019 Aug;97(5):e729-e735. doi: 10.1111/aos.14035. Epub 2019 Jan 28.
To determine the influence of baseline myopic macular degeneration (MMD) severity on outcomes with intravitreal aflibercept (IVT-AFL) in patients with myopic choroidal neovascularization (CNV).
MYRROR was a randomized, double-masked study in patients with myopic CNV treated with IVT-AFL/sham over 48 weeks. At baseline/week 48, images were retrospectively graded for MMD.
At baseline, 115 eyes had a valid MMD grading result; at week 48, grading results were available for 99 eyes [IVT-AFL (n = 78)/sham (n = 21)]. Severity of baseline MMD was distributed as follows: category 1: 19/115 (17%); category 2: 67/115 (58%); category 3: 22/115 (19%); category 4: 7/115 (6%). Higher MMD category was associated with older age (nominal p = 0.007) and longer axial length (nominal p = 0.025). At week 48, patients in the mild and severe groups had visual acuity gains of +13.5 and +12.4 letters, respectively. Baseline MMD severity did not significantly affect visual/anatomical outcomes or number of treatments. Visual Functioning Questionnaire-25 scores improved more in mild (+5.6) versus severe (+0.4) MMD (nominal p = 0.03). There were no new safety events.
Visual acuity gains, morphological outcomes and dosing frequency were not affected by baseline MMD severity in patients treated with IVT-AFL. A benefit with IVT-AFL treatment was observed for all baseline MMD stages included in this study.
确定基线近视性黄斑变性(MMD)严重程度对近视性脉络膜新生血管(CNV)患者玻璃体内注射阿柏西普(IVT-AFL)治疗结果的影响。
在 48 周的时间内,对接受 IVT-AFL/假注射治疗的近视性 CNV 患者进行了 MYRROR 随机、双盲研究。在基线/48 周时,对 MMD 进行了回顾性图像分级。
基线时,115 只眼有有效的 MMD 分级结果;48 周时,99 只眼(IVT-AFL[n=78]/假注射[n=21])有分级结果。基线 MMD 严重程度分布如下:1 类:19/115(17%);2 类:67/115(58%);3 类:22/115(19%);4 类:7/115(6%)。较高的 MMD 类别与年龄较大(名义 p=0.007)和眼轴较长(名义 p=0.025)相关。在第 48 周时,轻度和重度组的患者视力分别提高了+13.5 和+12.4 个字母。基线 MMD 严重程度并未显著影响视力/解剖学结局或治疗次数。与严重 MMD(+0.4)相比,轻度 MMD(+5.6)的视觉功能问卷-25 评分改善更明显(名义 p=0.03)。未出现新的安全事件。
在接受 IVT-AFL 治疗的患者中,基线 MMD 严重程度对视力提高、形态学结局和用药频率没有影响。在本研究中包括的所有基线 MMD 阶段均观察到 IVT-AFL 治疗的获益。