PURPOSE To describe the natural history of diabetic macular edema (DME) with respect to best-corrected visual acuity (BCVA) and central retinal thickness (CRT) outcomes and to identify baseline patient characteristics and systemic factors associated with improvement or worsening of outcomes in sham-treated patients. METHODS The study population was sham-treated patients (n = 350) in the 3-year MEAD registration study of dexamethasone intravitreal implant for treatment of DME. Patients had center-involved DME and received sham intravitreal injections in the study eye at ≥ 6-month intervals. Potential prognostic factors for outcomes were evaluated using multiple linear regression analysis. RESULTS Visual and anatomic outcomes were poorer in patients who left the study early (n = 198) than in study completers (n = 152). Mean change in BCVA from baseline at the last visit with available data was + 0.9 letters; 37.5% of patients had no change in BCVA, 23.2% had gained > 10 letters, and 16.0% had lost > 10 letters. Older age and baseline diabetic retinopathy score > 6 were associated with worse BCVA outcomes; thicker baseline CRT and larger number of hypertension medications used were associated with larger reductions in CRT during the study. CONCLUSIONS BCVA and CRT outcomes were variable in this population of DME patients with generally good glycemic control. In DME patients without active treatment, older age and baseline diabetic retinopathy score > 6 were associated with less improvement in BCVA; thicker baseline CRT and a larger number of antihypertensive medications used predicted better improvement in CRT. TRIAL REGISTRATION The MEAD study trials are registered at ClinicalTrials.gov with the identifiers NCT00168337 and NCT00168389.

中文翻译：

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糖尿病性黄斑水肿的自然病史和预测假治疗患者预后的因素（MEAD研究）。

目的描述关于最佳矫正视敏度（BCVA）和视网膜中央厚度（CRT）结局的糖尿病性黄斑水肿（DME）的自然病史，并确定与假性结局改善或恶化相关的基线患者特征和系统性因素治疗的患者。方法在为期3年的地塞米松玻璃体内植入物治疗DME的MEAD注册研究中，该研究人群为假治疗患者（n = 350）。患者患有中心性DME，并以≥6个月的间隔在研究眼中接受假玻璃体内注射。使用多元线性回归分析评估可能的预后因素。结果与研究完成者（n = 152）相比，早期离开研究的患者（n = 198）的视觉和解剖学结局较差。上次就诊时有可用数据的BCVA与基线相比的平均变化为+ 0.9个字母；37.5％的患者BCVA没有变化，23.2％的患者获得了> 10个字母，而16.0％的患者失去了> 10个字母。年龄较大和糖尿病视网膜病变基线评分> 6与较差的BCVA结局有关；在研究期间，基线CRT较厚，使用的高血压药物数量较多与CRT降低幅度较大有关。结论在总体上具有良好血糖控制的DME患者人群中，BCVA和CRT结果是可变的。在没有积极治疗的DME患者中，年龄较大和基线糖尿病视网膜病变评分> 6与BCVA改善较少相关；较厚的基线CRT和使用的大量降压药预示了CRT的改善。