摘要
目的 评估地塞米松玻璃体腔植入物（DEX）治疗中国患者视网膜静脉阻塞继发黄斑水肿（RVO-ME）的安全性和有效性.方法 为期6个月的随机、双盲、假注射对照、多中心、3期临床研究,此后接续为期2个月的开放标签的延展研究.视网膜分支（BRVO）或中央静脉阻塞（CRVO）患眼于基线时接受DEX植入（n=129）或假注射（n=130）治疗;治疗后6个月时,两组中满足再治疗标准的全部患眼均再次接受DEX植入治疗.有效性变量包括最佳矫正视力（BCVA）和黄斑中心凹视网膜厚度（CRT）.BCVA检查采用早期治疗糖尿病视网膜病变研究组视力表进行.光相干断层扫描（OCT）检查采用德国Heidelberg公司Spectralis OCT仪或德国Zeiss公司Cirrus OCT仪进行.结果 治疗后6个月中（主要终点）,DEX治疗组BCVA较基线提高≥15个字母的时间早于假注射组（P＜0.001）.治疗后第2个月时（效应峰值）,DEX治疗组、假注射组BCVA较基线提高≥15个字母患者百分比分别为34.9％,11.5％.DEX治疗组、假注射组平均BCVA较基线分别提高（10.6±10.4）、（1.7±12.3）个字母;平均CRT分别较基线下降（407±212）、（62±224） μm （P＜0.001）.DEX治疗组CRVO、BRVO患眼治疗效果均优于假注射组.主要常见治疗相关不良事件为眼压升高,均可通过局部降眼压药物控制;无患者需要接受抗青光眼手术.结论 DEX治疗中国患者RVO-ME具有良好的安全性和显著的临床疗效;单次植入DEX较假注射可获得持续3-4个月的视力和解剖结构改善.
Objective To evaluate the safety and efficacy ofdexamethasone intravitreal implant 0.7 mg （DEX） for treatment of macular edema associated with retinal vein occlusion （RVO）.Methods This study was a six-month,randomized,double-masked,sham-controlled,multicenter,phase 3 clinical trial with a 2-month open-label study extension.Patients with branch or central RVO received DEX （n=129） or sham procedure （n=130） in the study eye at baseline;all patients who met re-treatment criteria received DEX at month 6.Efficacy measures included Early Treatment Diabetic Retinopathy Study （ETDRS）,best-corrected visual acuity （BCVA）,and central retinal thickness （CRT） on optical coherence tomography.Results Time to 〉 15-letter BCVA improvement from baseline during the first 6 months （primary endpoint） was earlier with DEX than sham （P〈 0.001）.At month 2 （peak effect）,the percentage of patients with ≥ 15-letter BCVA improvement from baseline was DEX：34.9%,sham：11.5%;mean BCVA change from baseline was DEX：10.6± 10.4 letters,sham：1.7 ± 12.3 letters;and mean CRT change from baseline was DEX：-407 ± 212 μm,sham：-62 ± 224 μm （all P〈0.001）.Outcomes were better with DEX than sham in both branch and central RVO.The most common treatment-emergent adverse event was in-creased intraocular pressure （IOP）.Increase sin IOP generally were controlled with topical medication.Mean IOP normalized by month 4,and no patient required incisional glaucoma surgery.Conclusions DEX had a favorable safety profile and provided clinically significant benefit in a Chinese patient population with RVO.Visual and anatomic outcomes were improved with DEX relative to sham for 3-4 months after a single implant.
作者
黎晓新
王宁利
梁小玲
徐格致
Xiao-yan Li
Jenny Jiao
Jean Lou
Yehia Hashad
Li Xiaoxin;Wang Ningli;Liang Xiaoling;Xu Gezhi;Xiao-yan Li;Jenny Jiao;Jean Lou;Yehia Hashad;China Ozurdexin RVO Study Group(Department of Ophthalmology, Peking University People＇s Hospita;Key Laboratory of Vision Loss and Restoration, Ministry of Education, Beijing 100044, Chin;Beijing Tongren Eye Center, Beijing Institute of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Beijing 100730, China;State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Guangzhou 510060, Chin;Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai 200031, Chin;Allergan plc, Irvine, CA, US)
出处
《中华眼底病杂志》
CAS
CSCD
北大核心
2018年第3期212-220,共9页
Chinese Journal of Ocular Fundus Diseases
