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A 6-month, subject-masked, randomized controlled study to assess efficacy of dexamethasone as an adjunct to bevacizumab compared with bevacizumab alone in the treatment of patients with macular edema due to central or branch retinal vein occlusion

机译:为期6个月的受试者掩盖的随机对照研究,以评估地塞米松作为贝伐单抗的佐剂与单独贝伐单抗相比在治疗因中央或分支视网膜静脉阻塞而引起的黄斑水肿患者中的疗效

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Aims: To determine if intravitreal bevacizumab combined with the dexamethasone intravitreal implant?0.7?mg improves visual acuity and macular thickness more than bevacizumab monotherapy in eyes with macular edema due to branch and central retinal vein occlusions. Methods: Thirty eyes were randomly assigned to receive either combination therapy or bevacizumab monotherapy. All patients received intravitreal bevacizumab at baseline, followed by dexamethasone implants or sham injections?1?week later. Monthly bevacizumab injections were given if the central subfield thickness (CST) was >250?μm, and the combined group received a second implant at month?4?or?5?if CST was >250?μm. Results: At?6?months, several secondary endpoints were met. Patients receiving combined therapy required fewer bevacizumab reinjections compared to those receiving monotherapy (two versus three; P=0.02), experienced greater mean reductions in CST from randomization (–56?μm versus +45?μm; P=0.01), and were more likely to have resolved all edema (CST <250?μm) (7/11?versus?2/14; P=0.02). The primary endpoint was not met since mean visual acuity changes from baseline were similar in the two groups (P=0.75). Conclusion: In patients with macular edema due to vein occlusions, bevacizumab with dexamethasone implants produces greater improvements in macular thickness compared to bevacizumab monotherapy, despite fewer bevacizumab injections.
机译:目的:为了确定玻璃体腔内贝伐单抗联合地塞米松玻璃体植入物(0.7?mg)是否比贝伐单抗单药治疗因分支和视网膜中央静脉阻塞而引起的黄斑水肿改善视力和黄斑厚度。方法:30只眼随机分配接受联合治疗或贝伐单抗单药治疗。所有患者在基线时均接受玻璃体内贝伐单抗治疗,然后在1周后接受地塞米松植入或假注射。如果中心子区厚度(CST)> 250?μm,则每月进行一次贝伐单抗注射;如果CST> 250?μm,则合并组在第4?或?5?月进行第二次植入。结果:在6个月时,达到了一些次要终点。与接受单药治疗的患者相比,接受联合治疗的患者需要减少的贝伐单抗再注射次数(两次对比三例; P = 0.02),随机分组使平均CST降低更大(–56?μm对+45?μm; P = 0.01),并且更多可能已经解决了所有水肿(CST <250μm)(7/11对2/14; P = 0.02)。由于两组的平均视力从基线的变化相似,因此未达到主要终点(P = 0.75)。结论:在因静脉阻塞而导致黄斑水肿的患者中,与贝伐单抗单药治疗相比,贝伐单抗联合地塞米松植入物可改善黄斑厚度,尽管注射贝伐单抗的次数较少。

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