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Abstract：
OBJECTIVE: To evaluate the short-term effects (hours-days) of intravitreal dexamethasone implant (IDI) in eyes with diabetic macular edema (DME) refractory to anti-vascular endothelial growth factor (VEGF) injections.
METHODS: This was a prospective, single-arm, interventional clinical series. Eyes with DME and 3-9 injections of ranibizumab without a good response were included. Patients underwent a single IDI. Best-corrected visual acuity (BCVA) measurement, complete ophthalmic evaluation, and spectral-domain optical coherence tomography (SD-OCT) were performed at baseline, 2 h, 3 h, 24 h, 7 days, and 1 month. The main outcomes were change in central retinal thickness (CRT) on SD-OCT and BCVA.
RESULTS: Fifteen eyes of 15 patients were included. Mean CRT decreased after treatment from 515.87 µm ± 220.00 µm at baseline to 489.60 µm ± 176.53 µm after 2 h (p = 0.126), and 450.13 µm ± 163.43 at 24 h (p = 0.006). Change in BCVA was from 0.85 ± 0.44 logMAR baseline to 0.58 ± 0.37 log MAR at 1 month (p = 0.003).
CONCLUSIONS: Eyes treated with IDI showed significant decrease in CRT detectable 1 day after injection. In some patients, the effect could be observed 3 h post-implantation.
BACKGROUND: Clinicaltrials.gov NCT05736081 . Registered 20 February 2023, Retrospectively registered.
METHODS: This was a prospective, single-arm, interventional clinical series. Eyes with DME and 3-9 injections of ranibizumab without a good response were included. Patients underwent a single IDI. Best-corrected visual acuity (BCVA) measurement, complete ophthalmic evaluation, and spectral-domain optical coherence tomography (SD-OCT) were performed at baseline, 2 h, 3 h, 24 h, 7 days, and 1 month. The main outcomes were change in central retinal thickness (CRT) on SD-OCT and BCVA.
RESULTS: Fifteen eyes of 15 patients were included. Mean CRT decreased after treatment from 515.87 µm ± 220.00 µm at baseline to 489.60 µm ± 176.53 µm after 2 h (p = 0.126), and 450.13 µm ± 163.43 at 24 h (p = 0.006). Change in BCVA was from 0.85 ± 0.44 logMAR baseline to 0.58 ± 0.37 log MAR at 1 month (p = 0.003).
CONCLUSIONS: Eyes treated with IDI showed significant decrease in CRT detectable 1 day after injection. In some patients, the effect could be observed 3 h post-implantation.
BACKGROUND: Clinicaltrials.gov NCT05736081 . Registered 20 February 2023, Retrospectively registered.
摘要：
目的：评价玻璃体内注射地塞米松(IDI)治疗抗血管内皮生长因子(VEGF)治疗难治性糖尿病性黄斑水肿(DME)的短期疗效。
方法：这是一个前瞻性的，单臂,介入临床系列。包括DME和3-9次注射雷珠单抗而没有良好反应的眼睛。患者接受单一IDI。最佳矫正视力（BCVA）测量，完整的眼科评估，和谱域光学相干断层扫描（SD-OCT）在基线进行，2h,3h,24h,7天,和1个月。主要结果是SD-OCT和BCVA的中央视网膜厚度（CRT）变化。
结果：纳入15例患者的15只眼。治疗后平均CRT从基线时的515.87µm±220.00µm下降至2小时后的489.60µm±176.53µm（p=0.126），和450.13µm±163.43在24小时（p=0.006）。在1个月时,BCVA的变化从0.85±0.44logMAR基线到0.58±0.37logMAR(p=0.003)。
结论：用IDI治疗的眼睛在注射后1天显示可检测的CRT显著降低。在一些患者中，植入后3小时可以观察到效果。
背景：Clinicaltrials.govNCT05736081。2023年2月20日注册，追溯注册。
方法：这是一个前瞻性的，单臂,介入临床系列。包括DME和3-9次注射雷珠单抗而没有良好反应的眼睛。患者接受单一IDI。最佳矫正视力（BCVA）测量，完整的眼科评估，和谱域光学相干断层扫描（SD-OCT）在基线进行，2h,3h,24h,7天,和1个月。主要结果是SD-OCT和BCVA的中央视网膜厚度（CRT）变化。
结果：纳入15例患者的15只眼。治疗后平均CRT从基线时的515.87µm±220.00µm下降至2小时后的489.60µm±176.53µm（p=0.126），和450.13µm±163.43在24小时（p=0.006）。在1个月时,BCVA的变化从0.85±0.44logMAR基线到0.58±0.37logMAR(p=0.003)。
结论：用IDI治疗的眼睛在注射后1天显示可检测的CRT显著降低。在一些患者中，植入后3小时可以观察到效果。
背景：Clinicaltrials.govNCT05736081。2023年2月20日注册，追溯注册。
