Ozurdex in age-related macular degeneration as adjunct to ranibizumab (The OARA Study)
Ozurdex in age-related macular degeneration as adjunct to ranibizumab (The OARA Study)
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DOI：
10.1016/j.jcjo.2016.04.020
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发表时间：
2016-08-01
影响因子：
4.2
通讯作者：
Mohaghegh, S. Mohammad P.
中科院分区：
文献类型：
--
作者：
Chaudhary, Varun;Barbosa, Joshua;Mohaghegh, S. Mohammad P.
目的：评价地塞米松玻璃体内植入物（DXI; Ozurdex; Allergan，Irvine，CA）的实用性。与雷珠单抗联合（Lucentis; Novartis Pharma AG，巴塞尔，瑞士）对比雷珠单抗单一疗法在新生血管性年龄相关性黄斑变性（nAMD）队列中对视力（VA）和解剖学结果的影响。设计：多中心、单盲、初步随机对照试验。参与者：10例50岁或以上继发于AMD的中心凹下脉络膜新生血管患者随机接受DXI联合在3个月的雷珠单抗负荷期后，雷珠单抗（组1）或单独雷珠单抗（组2）。在两个研究组中，雷珠单抗给药6个月。从基线至研究终点的平均VA和中心黄斑厚度（CMT）降低（9个月）的不良事件发生率。结果：从基线到研究终点，视力改善10.8 +/- 13.2糖尿病视网膜病变的早期治疗对照组研究字母和干预组3.0 +/- 10.5字母（p = 0.331）。对照组和干预组的CMT分别降低了31.7% +/- 17.5%和13.3% +/- 27.0%（p = 0.236）。一名患者发展眼内压超过30毫米汞柱3个月后DXI administration.Conclusions：对于这nAMD的人口，没有视觉或解剖学的好处时，观察到治疗与DXI辅助雷珠单抗相对于雷珠单抗单药治疗。DXI相关不良事件与先前记录的地塞米松相关不良事件一致。
Objective: To evaluate the utility of dexamethasone intravitreal implant (DXI; Ozurdex; Allergan, Irvine, Calif.) in combination with ranibizumab (Lucentis; Novartis Pharma AG, Basel, Switzerland) versus ranibizumab monotherapy on visual acuity (VA) and anatomical outcomes in a neovascular age-related macular degeneration (nAMD) cohort.Design: Multicentred, single-blinded, pilot randomized control trial.Participants: Ten patients 50 years or older with subfoveal choroidal neovascularization secondary to AMD were randomized to receive DXI in combination with ranibizumab (group 1) or ranibizumab alone (group 2) after a 3-month ranibizumab loading period.Methods: Group 1 patients received 1 DXI after the loading phase with the option of retreatment at months 4 to 6. Ranibizumab was administered pro re nata for 6 months in both study arms. Mean VA and central macular thickness (CMT) reductions from baseline to study endpoint (9 months) were reported in addition to adverse event frequency across study cohorts.Results: From baseline to the study endpoint, VA improved by 10.8 +/- 13.2 Early Treatment of Diabetic Retinopathy Study letters in the control arm and 3.0 +/- 10.5 letters in the intervention arm (p = 0.331). CMT decreased by 31.7% +/- 17.5% and 13.3% +/- 27.0% (p = 0.236) for the control and intervention cohorts, respectively. One patient developed intraocular pressure in excess of 30 mm Hg 3 months after DXI administration.Conclusions: For this nAMD population, no visual or anatomical benefits were observed when treating with DXI in adjunct to ranibizumab relative to ranibizumab monotherapy. DXI-related adverse events were consistent with those previously documented for dexamethasone.