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BACKGROUND/OBJECTIVES: Diabetic macular edema (DME) is a significant cause of visual impairment, often treated with anti-vascular endothelial growth factor (anti-VEGF) agents. However, some patients do not respond adequately to this treatment. This study aims to evaluate the contribution of the intravitreal dexamethasone (DEX) implant as a second-line treatment in DME patients with insufficient response to anti-VEGF therapy or with high treatment burden.

METHODS

This retrospective multicenter cohort study was conducted across seven clinical sites in Switzerland. The study included eyes with active DME that had been pretreated with anti-VEGF for at least six months before receiving DEX therapy. Data were extracted from electronic patient records, focusing on best-corrected visual acuity (BCVA), central subfield thickness (CST), and injection frequency.

RESULTS

A total of 95 eyes from 89 patients (38.8% females, mean age 65.6 ± 9.1 years, follow-up time 80.6 ± 38.5 [13.5-166.7] months) were analyzed. Prior to the first DEX implant, eyes had undergone an average of 16.0 ± 13.3 anti-VEGF injections over 32.5 ± 22.4 months. Post-DEX treatment, 22.1% of eyes received DEX monotherapy, 44.2% received a combination of DEX and anti-VEGF, 25.3% continued with anti-VEGF monotherapy, and 8.4% received no further treatment. The number of anti-VEGF injections decreased significantly from 6.4 ± 3.1 in the year before DEX to 1.6 ± 2.4 in the year after DEX ( < 0.001). BCVA remained stable (0.4 ± 0.3 logMAR at baseline, 0.4 ± 0.5 logMAR at 24 months, = 0.2), while CST improved from 477.7 ± 141.0 to 320.4 ± 125.5 μm ( < 0.001), and the presence of retinal fluid decreased from 98.0% to 61.1% ( = 0.021). During follow-up, 26.3% of eyes required glaucoma medication, 4.2% underwent glaucoma surgery, and 1.1% needed cataract surgery.

CONCLUSIONS

In real-world clinical settings, the addition of DEX to anti-VEGF therapy in DME patients significantly reduces treatment burden and retinal fluid while maintaining visual function. Treatment decisions should balance anatomical and functional outcomes, considering individual patient needs.

背景/目的：糖尿病性黄斑水肿（DME）是导致视力损害的重要原因，通常采用抗血管内皮生长因子（anti-VEGF）药物进行治疗。然而，一些患者对这种治疗反应不佳。本研究旨在评估玻璃体内地塞米松（DEX）植入物作为二线治疗对anti-VEGF治疗反应不足或治疗负担高的DME患者的作用。

方法

这项回顾性多中心队列研究在瑞士的七个临床地点进行。该研究纳入了患有活动性DME的眼睛，这些眼睛在接受DEX治疗前至少已接受anti-VEGF预处理六个月。数据从电子病历中提取，重点关注最佳矫正视力（BCVA）、中心子野厚度（CST）和注射频率。

结果

共分析了来自89名患者的95只眼睛（女性占38.8%，平均年龄65.6±9.1岁，随访时间80.6±38.5[13.5 - 166.7]个月）。在首次植入DEX之前，眼睛在32.5±22.4个月内平均接受了16.0±13.3次anti-VEGF注射。DEX治疗后，22.1%的眼睛接受了DEX单药治疗，44.2%接受了DEX与anti-VEGF联合治疗，25.3%继续接受anti-VEGF单药治疗，8.4%未接受进一步治疗。anti-VEGF注射次数从DEX治疗前一年的6.4±3.1次显著减少至DEX治疗后一年的1.6±2.4次（<0.001）。BCVA保持稳定（基线时为0.4±0.3 logMAR，24个月时为0.4±0.5 logMAR，P = 0.2），而CST从477.7±141.0μm改善至320.4±125.5μm（<0.001），视网膜积液的存在从98.0%降至6l.1%（P = 0.021）。在随访期间，26.3%的眼睛需要青光眼药物治疗，4.2%接受了青光眼手术，1.1%需要白内障手术。