3.8 Article

Dexamethasone intravitreal implant in diabetic macular oedema refractory to anti-vascular endothelial growth factors: the AUSSIEDEX study

期刊

BMJ OPEN OPHTHALMOLOGY
卷 8, 期 1, 页码 -

出版社

BMJ PUBLISHING GROUP
DOI: 10.1136/bmjophth-2022-001224

关键词

Macula; Treatment Medical; Retina; Vision; Inflammation

向作者/读者索取更多资源

This study aimed to evaluate the effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX) monotherapy in the non-responder subgroup of the AUSSIEDEX study, which was defined by diabetic macular oedema (DME) refractory to anti-vascular endothelial growth factor (anti-VEGF) agents. The results showed that DEX significantly improved anatomical outcomes at 52 weeks without new safety concerns.
Aim 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. Methods 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. Primary endpoints: changes in mean BCVA and CRT from baseline to week 52. Safety assessments included adverse events. Results 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 mu m at week 52 (mean change -60.9 mu m; 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. Conclusion To date, AUSSIEDEX is the largest prospective, real- world study of DEX monotherapy for treatment- naive 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.

作者

我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。

评论

主要评分

3.8
评分不足

次要评分

新颖性
-
重要性
-
科学严谨性
-
评价这篇论文

推荐

暂无数据
暂无数据