Westmead Institute for Medical Research / Sydney West Retina, University of Sydney, Sydney, New South Wales, Australia
Marsden Eye Research, Sydney, New South Wales, Australia.
BMJ Open Ophthalmol. 2023 Aug;8(1). doi: 10.1136/bmjophth-2022-001224.
To evaluate effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX) monotherapy in the AUSSIEDEX study non-responder subgroup, defined by diabetic macular oedema (DME) refractory to anti-vascular endothelial growth factor (anti-VEGF) agents.
This prospective, open-label, observational, real-world study included pseudophakic and phakic (scheduled for cataract surgery) eyes that did not achieve a ≥5-letter best corrected visual acuity (BCVA) gain and/or clinically significant central subfield retinal thickness (CRT) improvement after 3-6 anti-VEGF injections for DME (N=143 eyes), regardless of baseline BCVA and CRT. After an initial DEX injection (baseline visit), reinjection was permitted at ≥16-week intervals.
changes in mean BCVA and CRT from baseline to week 52. Safety assessments included adverse events.
Of 143 eyes, 53 (37.1%) and 89 (62.2%) switched to DEX after 3-6 (early) and >6 (late) anti-VEGF injections, respectively; 1 (0.7%) had missing information. With 2.3 injections (mean) over 52 weeks, the change in mean BCVA from a baseline of 57.8 letters was not significant at week 52. Mean CRT improved significantly from a baseline of 417.8 μm at week 52 (mean change -60.9 μm; p<0.001). Outcomes were similar in eyes switched to DEX early and late. No unexpected adverse events were reported; no filtration surgeries were required.
To date, AUSSIEDEX is the largest prospective, real-world study of DEX monotherapy for treatment-naïve or anti-VEGF-refractory DME. Following early or late switch from anti-VEGF agents, DEX significantly improved anatomic outcomes at 52 weeks without new safety concerns, supporting use in anti-VEGF-refractory DME.
NCT02731911.
评估在 AUSSIEDEX 研究中，对于抗血管内皮生长因子（anti-VEGF）药物治疗抵抗的糖尿病黄斑水肿（DME）患者，即对 0.7mg 地塞米松玻璃体内植入物（DEX）单药治疗无反应亚组，DEX 单药治疗的有效性。
本前瞻性、开放性、观察性、真实世界研究纳入了假性和真性（计划行白内障手术）眼，这些患者在接受 3-6 次抗 VEGF 治疗 DME 后，无论基线最佳矫正视力（BCVA）和/或中央视网膜厚度（CRT）改善情况如何，均未达到 ≥5 个字母的 BCVA 增益和/或临床显著 CRT 改善（N=143 只眼）。在初次 DEX 注射（基线访视）后，可间隔至少 16 周进行再次注射。
从基线到 52 周时，平均 BCVA 和 CRT 的变化。安全性评估包括不良事件。
在 143 只眼中，分别有 53（37.1%）只眼和 89（62.2%）只眼在接受 3-6 次（早期）和＞6 次（晚期）抗 VEGF 治疗后转换为 DEX；1（0.7%）只眼缺失信息。在 52 周时，2.3 次注射（平均值）后，平均 BCVA 从基线的 57.8 个字母没有显著变化。CRT 从基线的 417.8μm显著改善，52 周时平均改善-60.9μm（p＜0.001）。在早期和晚期转换为 DEX 的眼中，结果相似。未报告任何意外的不良事件，也无需进行滤过性手术。
迄今为止，AUSSIEDEX 是最大的 DEX 单药治疗初治或抗 VEGF 治疗抵抗的 DME 的前瞻性、真实世界研究。在早期或晚期从抗 VEGF 药物转换后，DEX 可显著改善 52 周时的解剖学结果，且无新的安全性问题，支持其用于抗 VEGF 治疗抵抗的 DME。
NCT02731911。
