Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusionin Chinese patients: randomized, sham-controlled, multicenter study
10.3760/cma.j.issn.1005-1015.2018.03.003
- VernacularTitle: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
- Author:
Xiaoxin LI
1
;
Ningli WANG
;
Xiaoling LIANG
;
Gezhi XU
;
Li XIAO-YAN
;
Jiao JENNY
;
Lou JEAN
;
Hashad YEHIA
;
China Ozurdexin RVO Study Group
Author Information
1. 100044,北京大学人民医院眼科视觉损失与修复教育部重点实验室
- Keywords:
Corticosteroids;
Drug delivery systems;
Intravitreal injections;
Macular edema;
Retinal vein occlusion;
Randomized controlled trial
- From:
Chinese Journal of Ocular Fundus Diseases
2018;34(3):212-220
- CountryChina
- Language:Chinese
-
Abstract:
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.
