Cunha Renato B, Siqueira Rubens C, Messias André, Scott Ingrid U, Fialho Silvia Ligorio, Cunha-Junior Armando da Silva, Jorge Rodrigo
Department of Ophthalmology, Otorhinolaryngology and Head and Neck Surgery, Ribeirão Preto Medical School, University of São Paulo, Brazil.
Departments of Ophthalmology and Public Health Sciences, Penn State College of Medicine, Hershey, Pennsylvania.
Retin Cases Brief Rep. 2018;12(1):50-58. doi: 10.1097/ICB.0000000000000413.
To evaluate the safety and feasibility of a 25-gauge biodegradable implant containing 350 μg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion.
Prospective, nonrandomized, open-label, Phase I clinical trial, including 10 patients with decreased vision (best-corrected early treatment diabetic retinopathy study visual acuity of 20/40 or worse) due to macular edema associated with central retinal vein occlusion (n = 4) or branch retinal vein occlusion (n = 6) for more than 4 months. Comprehensive ophthalmic evaluation, including best-corrected visual acuity, spectral domain optical coherence tomography (Spectralis Heidelberg Engineering) for determination of central subfield thickness, full-field electroretinography (ISCEV standard ERG), and fluorescein angiography, was performed at baseline, and 1, 4, 12, and 24 weeks after intravitreal DDS-25 insertion.
Mean best-corrected visual acuity was 0.72 ± 0.1 logMAR (20/100) at baseline and improved by 7 early treatment diabetic retinopathy study letters to 0.58 ± 0.08 logMAR (20/80 + 1) at 24 weeks (P = 0.049), with 3 central retinal vein occlusion and 3 branch retinal vein occlusion patients improving between 1 and 4 early treatment diabetic retinopathy study lines. Significant central subfield thickness reduction was observed at 24 weeks compared with baseline (P = 0.011); mean ± standard error (range) central subfield thickness (μm) was 461.2 ± 41.3 (288-701) at baseline, and 439.6 ± 40.4 (259-631), 442.5 ± 44.6 (255-632), 354.6 ± 31.2 (228-537), and 316.5 ± 26.4 (226-441) at 1, 4, 12, and 24 weeks, respectively. No significant changes in electroretinography responses or area of retinal nonperfusion were observed during 24 weeks of follow-up. There was no significant change in mean intraocular pressure at any of the study visits compared with baseline. One patient had mild anterior chamber inflammation (1-5 cells) at one week after DDS-25 insertion.
In this Phase I study demonstrating the feasibility of intravitreal DDS-25 insertion for the treatment of decreased vision due to macular edema associated with retinal vein occlusion, no safety concerns were observed. A larger prospective randomized study with longer follow-up is warranted to confirm these findings.
评估含350μg地塞米松的25G可生物降解植入物（DDS - 25）治疗视网膜中央或分支静脉阻塞相关黄斑水肿所致视力下降的安全性和可行性。
前瞻性、非随机、开放标签的I期临床试验，纳入10例因视网膜中央静脉阻塞（n = 4）或分支视网膜静脉阻塞（n = 6）相关黄斑水肿导致视力下降（最佳矫正早期治疗糖尿病性视网膜病变研究视力为20/40或更差）超过4个月的患者。在基线以及玻璃体内植入DDS - 25后1、4、12和24周进行全面眼科评估，包括最佳矫正视力、用于测定中心子野厚度的光谱域光学相干断层扫描（海德堡工程公司的Spectralis）、全视野视网膜电图（国际临床视觉电生理学会标准ERG）和荧光素血管造影。
基线时平均最佳矫正视力为0.72±0.1 logMAR（20/100），24周时提高了7个早期治疗糖尿病性视网膜病变研究字母，达到0.58±0.08 logMAR（20/80 + 1）（P = 0.049），其中3例视网膜中央静脉阻塞和3例分支视网膜静脉阻塞患者的视力提高了1至4个早期治疗糖尿病性视网膜病变研究行。与基线相比，24周时观察到中心子野厚度显著降低（P = 0.011）；基线时中心子野厚度（μm）的平均值±标准误（范围）为461.2±41.3（288 - 701），1、4、12和24周时分别为439.6±40.4（259 - 631）、442.5±44.6（255 - 632）、354.6±31.2（228 - 537）和316.5±26.4（226 - 441）。随访24周期间，视网膜电图反应或视网膜无灌注区无显著变化。与基线相比，任何研究访视时平均眼压均无显著变化。1例患者在DDS - 25植入后1周出现轻度前房炎症（1 - 5个细胞）。
在这项I期研究中，玻璃体内植入DDS - 25治疗视网膜静脉阻塞相关黄斑水肿所致视力下降显示出可行性，未观察到安全问题。有必要进行一项更大规模、随访时间更长的前瞻性随机研究以证实这些发现。
