Department of Retina, University Eye Hospital "SVJETLOST", Zagreb, Croatia.
Retina. 2014 Apr;34(4):719-24. doi: 10.1097/IAE.0b013e3182a48958.
To investigate the efficiency of intravitreal dexamethasone implant in patients with chronic diabetic macular edema nonresponsive to three consecutive monthly intravitreal injections of anti-vascular endothelial growth factor administered previously.
Fifteen patients (16 eyes) were included in this 4-month prospective clinical trial. Main observed outcomes were the changes between initial and monthly visits in best-corrected visual acuity, central foveal thickness, and intraocular pressure (IOP). Patients included had central foveal thickness of >225 μm (measured by optical coherence tomography) and were nonresponsive to previously administered 3 consecutive monthly intravitreal injections of 1.25-mg bevacizumab. Administration of intravitreal dexamethasone implant was performed at baseline, and patients were followed-up monthly.
Statistically significant changes from baseline were observed in best-corrected visual acuity (at 2 months), central foveal thickness (at 1, 2, and 3 months), and IOP (at Months 1, 2, and 3) as follows: mean best-corrected visual acuity significantly increased from 0.29 Snellen lines at baseline to 0.39 lines after 2 months (P = 0.0381). At Months 1, 2, and 3, the mean central foveal thickness significantly decreased, from 462 μm at baseline, to 366 μm (P = 0.0343), 346 μm (P = 0.0288), and 355 μm (P = 0.0370), respectively. When compared with baseline IOP of 15.38 mmHg (12-19 mmHg), IOP increased significantly at Months 1, 2, and 3: 18.93 mmHg (range, 16-24 mmHg; P = 0.0003), 19.5 mmHg (range, 16-27 mmHg; P = 0.0003), and 17.5 mmHg (range, 15-21 mmHg; P = 0.0048), respectively.
Dexamethasone intravitreal implant may present an alternative option in the treatment of chronic diabetic macular edema nonresponsive to three consecutive monthly bevacizumab injections administered previously. However, IOP measures were only slightly increased. It seems that the effect of dexamethasone may last till 4 months after initial injection.
研究玻璃体内注射地塞米松植入物对先前连续 3 个月每月注射抗血管内皮生长因子治疗无反应的慢性糖尿病性黄斑水肿患者的疗效。
本前瞻性临床试验纳入了 15 名（16 只眼）患者。主要观察指标为最佳矫正视力、中心凹视网膜厚度和眼内压（IOP）在初始和每月随访时的变化。患者的中心凹视网膜厚度>225μm（经光学相干断层扫描测量），且对先前连续 3 个月每月注射 1.25mg 贝伐单抗治疗无反应。在基线时行玻璃体内注射地塞米松植入物治疗，并进行每月随访。
与基线相比，最佳矫正视力（在 2 个月时）、中心凹视网膜厚度（在 1、2 和 3 个月时）和 IOP（在 1、2 和 3 个月时）均有统计学显著变化：最佳矫正视力从基线时的 0.29 行提高到 2 个月时的 0.39 行（P = 0.0381）。在第 1、2 和 3 个月时，中心凹视网膜厚度分别从基线时的 462μm 显著下降至 366μm（P = 0.0343）、346μm（P = 0.0288）和 355μm（P = 0.0370）。与基线时的 15.38mmHg（12-19mmHg）相比，IOP 在第 1、2 和 3 个月时显著升高：18.93mmHg（范围，16-24mmHg；P = 0.0003）、19.5mmHg（范围，16-27mmHg；P = 0.0003）和 17.5mmHg（范围，15-21mmHg；P = 0.0048）。
对于先前连续 3 个月每月注射贝伐单抗治疗无反应的慢性糖尿病性黄斑水肿患者，玻璃体内注射地塞米松植入物可能是一种替代治疗选择。然而，IOP 测量值仅略有升高。似乎地塞米松的作用可以持续到初始注射后 4 个月。
