Singer Michael A, Jansen Michael E, Tyler Lyndon, Woods Paul, Ansari Faisal, Jain Udit, Singer Joshua, Bell Darren, Krambeer Chelsey
Medical Center Ophthalmology Associates.
University of Texas Health and Science Center at San Antonio, San Antonio, TX, USA.
Clin Ophthalmol. 2016 Dec 19;11:31-38. doi: 10.2147/OPTH.S119373. eCollection 2017.
One limitation of anti-VEGF therapy is the need for monthly retreatment to maintain efficacy. The purpose of this study was to determine the duration of effect in eyes with macular edema (ME) secondary to branch or central retinal vein occlusion (BRVO or CRVO) treated with anti-VEGF therapy plus sustained-release dexamethasone (DEX implant; Ozurdex).
This open-label, interventional case series included 62 eyes with ME due to RVO, central foveal thickness (CFT) >300 μm, and best-corrected visual acuity (BCVA) of 20/40 or worse. Each treatment cycle included an anti-VEGF injection followed 2 weeks later with DEX implant. Patients were eligible for retreatment if CFT increased to >290 μm or increased by >50 μm from the lowest measurement, or if BCVA decreased by six or more Snellen letters. Efficacy and safety were evaluated 2 and 4-6 weeks after the beginning of each treatment cycle and every 4 weeks thereafter until retreatment criteria were met. The primary outcome measure was time to retreatment. Secondary outcome measures included BCVA, CFT, and safety parameters.
The mean reinjection interval for all patients was 135.5±36.4 days. There was no statistically significant difference in mean intertreatment interval for up to six cycles of treatment or between eyes with BRVO or CRVO (≥0.058). Mean peak change in BCVA was 13.8 letters, and 47.6% of eyes gained three or more lines of BCVA. The mean peak decrease in CFT across all treatment cycles was 200.9 μm for eyes with BRVO and 219.2 μm for eyes with CRVO. The percentage of patients with CFT ≤300 μm at any time during a given treatment cycle ranged from 78% to 94% among eyes with BRVO and from 85% to 100% among eyes with CRVO. Intraocular pressure increased in 19 of 62 eyes, and 26 of 44 phakic eyes underwent cataract surgery.
In eyes with ME due to RVO, treatment with an anti-VEGF agent plus DEX implant provided a predictable duration of effect, as well as significant improvements in BCVA and CFT.
抗血管内皮生长因子（VEGF）治疗的一个局限性是需要每月再次治疗以维持疗效。本研究的目的是确定接受抗VEGF治疗联合缓释地塞米松（DEX植入物；Ozurdex）治疗的继发于视网膜分支静脉阻塞（BRVO）或视网膜中央静脉阻塞（CRVO）的黄斑水肿（ME）患者眼部的疗效持续时间。
本开放标签、介入性病例系列研究纳入了62只因视网膜静脉阻塞导致ME、中心凹厚度（CFT）>300μm且最佳矫正视力（BCVA）为20/40或更差的眼睛。每个治疗周期包括一次抗VEGF注射，2周后植入DEX。如果CFT增加至>290μm或较最低测量值增加>50μm，或者BCVA下降6个或更多Snellen视力表字母，则患者有资格接受再次治疗。在每个治疗周期开始后2周和4 - 6周以及此后每4周评估疗效和安全性，直至达到再次治疗标准。主要结局指标是至再次治疗的时间。次要结局指标包括BCVA、CFT和安全性参数。
所有患者的平均再次注射间隔为135.5±36.4天。在长达六个治疗周期内，或在BRVO或CRVO患者的眼睛之间，平均治疗间隔无统计学显著差异（≥0.058）。BCVA的平均峰值变化为13.8个字母，47.6%的眼睛BCVA提高了三行或更多。在所有治疗周期中，BRVO患者眼睛的CFT平均峰值下降200.9μm，CRVO患者眼睛的CFT平均峰值下降219.2μm。在给定治疗周期的任何时间，CFT≤300μm的患者百分比在BRVO患者的眼睛中为78%至94%，在CRVO患者的眼睛中为85%至100%。62只眼中有19只眼眼压升高，44只晶状体眼中有26只接受了白内障手术。
在因视网膜静脉阻塞导致ME的患者眼中，抗VEGF药物联合DEX植入物治疗可提供可预测的疗效持续时间，以及BCVA和CFT的显著改善。
