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治疗糖尿病性黄斑水肿(DMO):英国真实世界中0.19毫克醋酸氟轻松玻璃体内植入剂(Iluvien™)2年的临床疗效

Treating Diabetic Macular Oedema (DMO): real world UK clinical outcomes for the 0.19mg Fluocinolone Acetonide intravitreal implant (Iluvien™) at 2 years.

作者信息

Fusi-Rubiano William, Mukherjee Chandoshi, Lane Mark, Tsaloumas Marie D, Glover Nicholas, Kidess Andrej, Denniston Alastair K, Palmer Helen E, Manna Avinash, Morjaria Rupal

机构信息

Ophthalmology Department, Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHSFT, Mindelsohn Way, Birmingham, B15 2TH, United Kingdom.

Sandwell & West Birmingham NHS Trust, Dudley Road, Birmingham, B18 7QH, United Kingdom.

出版信息

BMC Ophthalmol. 2018 Feb 27;18(1):62. doi: 10.1186/s12886-018-0726-1.

Abstract

BACKGROUND

To compare visual function and structural improvements in pseudophakic eyes with diabetic macular oedema (DMO) treated with the 0.19mg Fluocinolone Acetonide (FAc) intravitreal implant (Iluvien) in a 'real world' setting.

METHODS

A single centre retrospective evaluation of patients with DMO unresponsive to conventional treatment treated with the FAc implant according to UK guidelines. Primary efficacy endpoint was best corrected visual acuity (BCVA); secondary endpoints included optical coherence tomography evaluations of the macula (a) central retinal and (b) peak macular thickness collected at annual time points. Primary safety endpoint was new rise in IOP >27mmHg or glaucoma surgery. Patients with <1 year follow-up were excluded.

RESULTS

Twenty-nine eyes were included, with mean(SD) follow up of 792(270) days. Improvement in BCVA and reduction in macular oedema was noted at all timepoints. Mean improvement in BCVA from baseline was 6 ETDRS letters at year 1(n=29), 6.5L at year 2(n=22) and 11L at year 3(n=6). Mean central retinal thickness at baseline was 451 microns, 337 microns at year 1, 342 microns at year 2 and 314 microns at year 3. Two eyes required IOP-lowering drops post implant. Supplementary treatment for persistence or recurrence of DMO was necessary in 18 eyes over the total study period of 3 years with mean time to supplementary treatment being 12 months.

CONCLUSIONS

Our evaluation of the 0.19mg FAc implant delivered in a real-world setting, provides additional evidence that it is effective and safe in the treatment of patients with DMO, and can provide sustained benefit for patients with previously refractory disease.

摘要

背景

在“真实世界”环境中,比较接受0.19毫克醋酸氟轻松(FAc)玻璃体内植入物(Iluvien)治疗的糖尿病性黄斑水肿(DMO)假晶状体眼中的视觉功能和结构改善情况。

方法

根据英国指南,对接受FAc植入物治疗但对传统治疗无反应的DMO患者进行单中心回顾性评估。主要疗效终点是最佳矫正视力(BCVA);次要终点包括黄斑的光学相干断层扫描评估(a)中央视网膜和(b)每年时间点收集的黄斑峰值厚度。主要安全终点是眼压新升高>27mmHg或青光眼手术。排除随访时间<1年的患者。

结果

纳入29只眼,平均(标准差)随访792(270)天。在所有时间点均观察到BCVA改善和黄斑水肿减轻。BCVA从基线的平均改善在第1年为6个ETDRS字母(n = 29),第2年为6.5个字母(n = 22),第3年为11个字母(n = 6)。基线时平均中央视网膜厚度为451微米,第1年为337微米,第2年为342微米,第3年为314微米。两只眼在植入后需要使用降眼压滴眼液。在3年的总研究期间,18只眼需要补充治疗DMO的持续或复发,补充治疗的平均时间为12个月。

结论

我们在真实世界环境中对0.19mg FAc植入物的评估提供了额外证据,表明其在治疗DMO患者中有效且安全,并可为先前难治性疾病的患者提供持续益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7dae/6389097/5ccb5510db2e/12886_2018_726_Fig1_HTML.jpg

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