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.

abstractsObjective 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.