Valentim Carolina C S, Lai Hongxin, Ogidigben Miller J, Singh Rishi P, Talcott Katherine E
Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic Foundation, 9500 Euclid Ave. i32, Cleveland, OH, 44195, USA.
Kentucky Lions Eye Center, University of Louisville, Louisville, KY, USA.
BMC Ophthalmol. 2025 Jul 9;25(1):403. doi: 10.1186/s12886-025-04208-3.
Considering evidence that some baseline clinical parameters correlate with diabetic macular oedema (DME) response to intravitreal anti-VEGF treatment and prognosis, investigation of baseline characteristics that could predict treatment response to dexamethasone intravitreal implant (DEX) and facilitate treatment selection was warranted. This study evaluated the relationship between baseline characteristics and time to first DME resolution in patients treated with DEX.
This post hoc analysis of the MEAD study (which consisted of 2 randomised, multicentre, masked, sham-controlled, phase 3 clinical trials identical in design) included 351 eyes treated with DEX 0.7 mg and 350 with sham over 3 years, with retreatment possible every ≥ 6 months if eligibility criteria were met. The effect of baseline characteristics on the time to first DME resolution (defined as central retinal/subfield thickness [CRT] < 250 μm) was evaluated with univariate and multivariate models, and further assessed with Kaplan-Meier method.
The median (95% CI) time to first DME resolution was 9.0 (8.5-9.3) months for the DEX group. The hazard ratio for DME resolution (DEX versus sham) was 2.09 (P < 0.0001). Higher CRT was associated with longer time to DME resolution.
Treatment with DEX shortened the time to DME resolution compared with sham. Higher CRT was associated with longer time to DME resolution. These findings may influence therapeutic decisions.
clinicaltrials.gov NCT00168337 and NCT00168389.
鉴于有证据表明一些基线临床参数与糖尿病性黄斑水肿（DME）对玻璃体内抗血管内皮生长因子（VEGF）治疗的反应及预后相关，因此有必要研究能够预测地塞米松玻璃体内植入物（DEX）治疗反应并有助于治疗选择的基线特征。本研究评估了接受DEX治疗患者的基线特征与首次DME消退时间之间的关系。
本研究是对MEAD研究（由2项设计相同的随机、多中心、盲法、假手术对照的3期临床试验组成）的事后分析，纳入了351只接受0.7mg DEX治疗的眼睛和350只接受假手术治疗的眼睛，为期3年，若符合入选标准，每≥6个月可再次治疗。采用单变量和多变量模型评估基线特征对首次DME消退时间（定义为中心视网膜/子区域厚度[CRT]<250μm）的影响，并采用Kaplan-Meier方法进行进一步评估。
DEX组首次DME消退的中位（95%CI）时间为9.0（8.5-9.3）个月。DME消退的风险比（DEX组与假手术组）为2.09（P<0.0001）。较高的CRT与DME消退时间延长相关。
与假手术相比，DEX治疗缩短了DME消退时间。较高的CRT与DME消退时间延长相关。这些发现可能会影响治疗决策。
clinicaltrials.gov NCT00168337和NCT00168389。
