地塞米松玻璃体腔植入剂治疗中国患者视网膜静脉阻塞继发黄斑水肿的安全性和有效性：随机、假注射对照、多中心研究

Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusionin Chinese patients： randomized, sham-controlled, multicenter study

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.