曲安奈德眼内液缓释系统治疗视网膜静脉阻塞继发黄斑囊样水肿。

Sustained-release intravitreal liquid drug delivery using triamcinolone acetonide for cystoid macular edema in retinal vein occlusion.

机构信息

Department of Ophthalmology and Visual Sciences, University of Illinois, Chicago, IL, USA.

出版信息

Ophthalmology. 2011 Jul;118(7):1416-22. doi: 10.1016/j.ophtha.2010.12.029. Epub 2011 Mar 12.

DOI:10.1016/j.ophtha.2010.12.029

PMID:21397950

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3735605/

Abstract

PURPOSE

To investigate side effects seen with this formulation and to search for evidence of effectiveness after a single intravitreal injection of IBI-20089 in eyes with cystoid macular edema (CME) secondary to retinal vein occlusion.

DESIGN

Prospective, phase 1 clinical trial.

PARTICIPANTS

Ten patients with chronic CME resulting from retinal vein occlusion.

METHODS

Patients received a single intravitreal injection of IBI-20089 using a sequential dose escalation schedule. Each cohort consisted of 5 patients who received the intravitreal injection of the sustained liquid drug delivery system containing either 6.9 mg (25 μl) triamcinolone acetonide (TA; cohort 1) or 13.8 mg (50 μl) TA (cohort 2). At each study visit, best-corrected visual acuity testing, slit-lamp biomicroscopy, IOP measurement, dilated ophthalmoscopy, fundus photography and optical coherence tomography (OCT) were performed. Patients also underwent laboratory testing and physical examinations to monitor for any systemic adverse events.

MAIN OUTCOME MEASURES

Optical coherence tomography central subfield thickness, ocular and systemic adverse events.

RESULTS

In cohort 1, mean baseline OCT central subfield thickness (CST) was 477 μm and decreased to 369 μm at day 1 (P<0.06), 387 μm at day 30 (P = 0.18), and 251 μm at day 360 (P = 0.46). In cohort 2, mean baseline OCT CST was 518 μm and decreased to 404 μm at day 1 (P = 0.134), 289 μm at day 30 (P = 0.003), 207 μm at day180 (P = 0.004), and 278 μm at day 360 (P = 0.009). Related adverse events included elevation of IOP in 3 patients, in 2 because of neovascular glaucoma (not related to study drug) and in 1 who required a glaucoma tube shunt.

CONCLUSIONS

A single intravitreal injection of IBI-20089 resulted in a controlled and sustained delivery of a TA. Side effects included elevated IOP in 3 eyes, 2 of which had neovascular glaucoma.

摘要

目的

研究该制剂的副作用，并在单次玻璃体内注射 IBI-20089 后寻找继发于视网膜静脉阻塞的囊样黄斑水肿（CME）患者的有效性证据。

设计

前瞻性、1 期临床试验。

参与者

10 例慢性 CME 患者继发于视网膜静脉阻塞。

方法

患者接受了 IBI-20089 的单次玻璃体内注射，使用连续剂量递增方案。每个队列由 5 名患者组成，他们接受了含有 6.9 毫克（25 μl）曲安奈德（TA；队列 1）或 13.8 毫克（50 μl）TA（队列 2）的持续液体药物递送系统的玻璃体内注射。在每次研究访问时，进行最佳矫正视力测试、裂隙灯生物显微镜检查、眼压测量、散瞳检眼镜检查、眼底照相和光学相干断层扫描（OCT）。患者还接受了实验室检查和体格检查，以监测任何全身不良事件。

主要观察指标

OCT 中央视野厚度、眼部和全身不良事件。

结果

在队列 1 中，平均基线 OCT 中央视野厚度（CST）为 477 μm，第 1 天降至 369 μm（P<0.06），第 30 天降至 387 μm（P = 0.18），第 360 天降至 251 μm（P = 0.46）。在队列 2 中，平均基线 OCT CST 为 518 μm，第 1 天降至 404 μm（P = 0.134），第 30 天降至 289 μm（P = 0.003），第 180 天降至 207 μm（P = 0.004），第 360 天降至 278 μm（P = 0.009）。相关不良事件包括 3 例患者眼压升高，其中 2 例因新生血管性青光眼（与研究药物无关），1 例需要青光眼引流管。