Neves Pedro, Ornelas Mário, Matias Inês, Rodrigues João, Santos Margarida, Dutra-Medeiros Marco, Martins David
Department of Ophthalmology, Centro Hospitalar de Setúbal, Setúbal 2910-549, Portugal.
Department of Ophthalmology, Hospital Beatriz Ângelo, Loures 2674-514, Portugal.
Int J Ophthalmol. 2021 Oct 18;14(10):1571-1580. doi: 10.18240/ijo.2021.10.15. eCollection 2021.
To investigate the safety and efficacy of intravitreal dexamethasone implants (Ozurdex/DEX) in patients with diabetic macular edema (DME) either naïve or non-naïve to anti-VEGF therapies who switched to DEX implant independent of response to anti-vascular endothelial growth factors (anti-VEGFs).
This was an audit retrospective review of medical records of patients with DME who switched to the DEX intravitreal implant. Patients were divided into 2 groups: patients naïve to antiangiogenic therapy and patients who were previously treated with anti-VEGFs. Data regarding demographics, changes in mean best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) was collected over 6mo. The demographic data mean changes in BCVA, CMT, and IOP were compared. Six-month follow-up data of 47 patients (57 eyes), who either switched to DEX implant irrespective of response to previous treatments or were treatment naïve before receiving DEX implant, was collected.
Improvement in mean BCVA was observed from 1-4mo after injection with a decreased effect at month 6 as expected, with better outcomes in naïve compared to non-naïve patients. A statistically relevant decrease in mean CMT was observed during the follow-up period. An increase in mean IOP was observed in the first 2mo after DEX therapy. The mean number of injections of the overall population during the 6mo was 1.3. A subgroup analysis showed no relevant difference between phakic versus pseudophakic patients relative to measured outcomes. There was no cataract progression during the follow-up period and no adverse events reported.
This real-life setting study shows that intravitreal DEX implant is effective and safe. The timings of greater therapeutic impact are concordant with previous studies and suggest that earlier treatment with corticosteroids may have an additional benefit in naïve patients.
研究玻璃体内注射地塞米松植入剂（Ozurdex/DEX）在初治或非初治抗血管内皮生长因子（anti-VEGF）治疗的糖尿病性黄斑水肿（DME）患者中，无论其对anti-VEGF治疗反应如何而改用DEX植入剂后的安全性和有效性。
这是一项对改用DEX玻璃体内植入剂的DME患者病历的回顾性审计。患者分为两组：抗血管生成治疗初治患者和既往接受过anti-VEGF治疗的患者。收集6个月内的人口统计学数据、平均最佳矫正视力（BCVA）、中心黄斑厚度（CMT）和眼压（IOP）的变化情况。比较人口统计学数据、BCVA、CMT和IOP的平均变化。收集了47例患者（57只眼）的6个月随访数据，这些患者要么无论对先前治疗的反应如何而改用DEX植入剂，要么在接受DEX植入剂之前未接受过治疗。
注射后1至4个月观察到平均BCVA有所改善，如预期在第6个月效果降低，初治患者的结果优于非初治患者。随访期间观察到平均CMT有统计学意义的下降。DEX治疗后前2个月观察到平均IOP升高。6个月内总体人群的平均注射次数为1.3次。亚组分析显示，相对于测量结果，有晶状体眼与人工晶状体眼患者之间无显著差异。随访期间无白内障进展，也未报告不良事件。
这项真实环境研究表明，玻璃体内DEX植入剂有效且安全。更大治疗效果的时间点与先前研究一致，提示早期使用皮质类固醇治疗可能对初治患者有额外益处。
