光学相干断层扫描生物标志物：玻璃体状态对 0.19mg 氟轻松醋酸酯植入物治疗糖尿病性黄斑水肿结局的影响。

Optical Coherence Tomography Biomarkers: Vitreous Status Influence in Outcomes for Diabetic Macular Edema Therapy with 0.19-mg Fluocinolone Acetonide Implant.

机构信息

Department of Ophthalmology, Centro Hospitalar Universitário do Porto, Porto, Portugal.

Department of Ophthalmology, Instituto de Ciências Biomédicas Abel Salazar, University of Porto, Porto, Portugal.

出版信息

Ophthalmic Res. 2021;64(4):639-647. doi: 10.1159/000515306. Epub 2021 Mar 17.

DOI:10.1159/000515306

PMID:33601389

Abstract

BACKGROUND

The 0.19-mg fluocinolone acetonide (FAc) implant (ILUVIEN®; Alimera Sciences Ltd., Hampshire, UK) was approved for the treatment of vision impairment associated with chronic and refractory diabetic macular edema (DME).

OBJECTIVES

To quantitatively assess functional and structural features in nonvitrectomized and vitrectomized DME patients after being treated with an FAc implant.

METHODS

Retrospective review of patients with DME receiving a single intravitreal injection of the FAc implant. The study was designed to analyze the presence of quantitative structural OCT biomarkers at baseline and 12 months after FAc therapy according to vitreous status.

RESULTS

A total of 41 eyes from 30 patients were included in this study. At 12 months after injection, vitrectomized patients had a lower central foveal thickness (p = 0.017) and fewer hyperreflective dots (p = 0.028) compared with nonvitrectomized. Thirty (73%) patients presented a significant functional improvement with 17 (42%) increasing at least 15 ETDRS letters. Overall, 22 (54%) eyes had a complete resolution of DME at the 12-month visit. Patients who needed additional therapy had a higher prevalence of subretinal fluid (42 vs. 3%, p = 0.005) at baseline.

CONCLUSIONS

This study supports the effectiveness of the FAc implant and reports significant changes at 12 months after FAc injection.

摘要

背景

0.19 毫克氟轻松戊酸酯（FAc）植入物（ILUVIEN ® ；Alimera Sciences Ltd.，英国汉普郡）已获批准用于治疗与慢性和难治性糖尿病性黄斑水肿（DME）相关的视力损害。

目的

定量评估非玻璃体切割和玻璃体切割的 DME 患者在接受 FAc 植入物治疗后的功能和结构特征。

方法

回顾性分析接受单次玻璃体内 FAc 植入物注射的 DME 患者。该研究旨在根据玻璃体状态分析 FAc 治疗后基线和 12 个月时定量结构 OCT 生物标志物的存在。

结果

本研究共纳入 30 例 41 只眼。注射后 12 个月，玻璃体切割组的中央视网膜黄斑厚度（p = 0.017）和高反射点（p = 0.028）均低于非玻璃体切割组。30 例（73%）患者的功能显著改善，其中 17 例（42%）至少增加了 15 个 ETDRS 字母。总体而言，22 只（54%）眼在 12 个月时 DME 完全消退。需要额外治疗的患者在基线时存在更多的视网膜下液（42%比 3%，p = 0.005）。