Maturi Raj K, Bleau Laura, Saunders Jeffrey, Mubasher Mohamed, Stewart Michael W
*Midwest Eye Institute, Indianapolis, Indiana; †Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana; ‡Jaeb Center for Health Research, Tampa, Florida; and §Department of Ophthalmology, Mayo Clinic Florida, Jacksonville, Florida.
Retina. 2015 Aug;35(8):1604-14. doi: 10.1097/IAE.0000000000000533.
To determine whether a dexamethasone intravitreal implant 0.7 mg (dexamethasone delivery system [DDS], Ozurdex) combined with bevacizumab 1.25 mg (Avastin) provides greater benefit than bevacizumab monotherapy in eyes with diabetic macular edema with incomplete response to multiple antivascular endothelial growth factor injections.
Eyes with diabetic macular edema were randomly assigned to receive combination therapy (bevacizumab plus DDS) or bevacizumab monotherapy. Combination therapy eyes received intravitreal bevacizumab at baseline, DDS at Month 1, and subsequent DDS (at Months 5 and 9), whereas monotherapy eyes received bevacizumab (monthly) if indicated. Eyes were eligible for retreatment if the central subfield thickness measured >250 μm, and Early Treatment of Diabetic Retinopathy Study visual acuity was <80 letters (20/25).
Forty eyes of 30 patients were enrolled. The mean visual acuity changes from baseline to 12 months were similar in the 2 groups (combined: +5.4 letters; bevacizumab: +4.9 letters; difference = 0.2 letters, 95% confidence interval = -5.9 to 6.3; P = 0.75). The mean reduction in central subfield thickness was greater in the combination group (-45 μm vs. -30 μm, difference = 69 μm, 95% confidence interval = 9-129; P = 0.03) and more patients in the combination group had central subfield thickness <250 μm. The combined treatment group received three fewer supplemental injections of bevacizumab, but this was counterbalanced by the need for an average of 2.1 DDS injections.
The dexamethasone implant combined with bevacizumab significantly improves visual acuity and significantly improves macular morphology in eyes with refractory diabetic macular edema, although visual acuity changes are not superior to continued bevacizumab monotherapy.
确定0.7毫克地塞米松玻璃体内植入物（地塞米松给药系统[DDS]，Ozurdex）联合1.25毫克贝伐单抗（阿瓦斯汀）治疗对多次抗血管内皮生长因子注射反应不完全的糖尿病性黄斑水肿患者是否比单纯使用贝伐单抗更有益。
将患有糖尿病性黄斑水肿的眼睛随机分为联合治疗组（贝伐单抗加DDS）或贝伐单抗单药治疗组。联合治疗组在基线时接受玻璃体内注射贝伐单抗，第1个月接受DDS，随后在第5个月和第9个月接受DDS；而单药治疗组根据需要每月接受贝伐单抗治疗。如果中心子野厚度测量值>250μm且糖尿病视网膜病变早期治疗研究视力<80字母（20/25），则眼睛符合再次治疗标准。
30例患者的40只眼睛被纳入研究。两组从基线到12个月的平均视力变化相似（联合治疗组：+5.4字母；贝伐单抗组：+4.9字母；差异=0.2字母，95%置信区间=-5.9至6.3；P=0.75）。联合治疗组中心子野厚度的平均降低幅度更大（-45μm对-30μm，差异=69μm，95%置信区间=9-129；P=0.03），联合治疗组更多患者的中心子野厚度<250μm。联合治疗组接受的贝伐单抗补充注射少3次，但这被平均需要2.1次DDS注射所抵消。
地塞米松植入物联合贝伐单抗可显著提高难治性糖尿病性黄斑水肿患者的视力并显著改善黄斑形态，尽管视力变化并不优于持续的贝伐单抗单药治疗。
