Talcott Katherine E, Valentim Carolina C S, Hill Lauren, Stoilov Ivaylo, Singh Rishi P
Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Center for Ophthalmic Bioinformatics, Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Ophthalmol Retina. 2023 Jul;7(7):605-611. doi: 10.1016/j.oret.2023.02.003. Epub 2023 Feb 10.
Having a better understanding of how long diabetic macular edema (DME) takes to resolve in patients with diabetic retinopathy (DR) after treatment with ranibizumab, and the factors affecting this outcome, would be of benefit to physicians and patients alike. The objective of this analysis was to evaluate the time to first DME resolution and the impact of baseline DR severity on this outcome in patients treated with ranibizumab in phase III clinical trials.
Meta-analysis of data from the phase III trials, RIDE (NCT00473382) and RISE (NCT00473330), and DR Clinical Research Network protocols I (NCT00444600), S (NCT01489189), and T (NCT01627249).
Patients with DME (central subfield thickness [CST] > 250 μm) and DR with Diabetic Retinopathy Severity Scale (DRSS) score between 35 and 85.
Intravitreal injection of ranibizumab.
The time to first DME resolution (defined as CST ≤ 250 μm) within 24 months was evaluated overall and by baseline DR severity category per the DRSS (35 of 43 [mild or moderate nonproliferative DR], 47-53 [moderately severe or severe nonproliferative DR], 60 [mild proliferative DR], and 61-85 [moderately severe to severe proliferative DR]).
There were 777 patients included in the meta-analysis. The overall mean (95% confidence interval) time to first DME resolution, adjusted for baseline CST, was 6.0 (5.6-6.4) months. The mean (95% CI) time to first DME resolution was 7.1 (6.2-7.9), 5.9 (5.2-6.6), 6.0 (4.8-7.2), and 4.5 (3.5-5.5) months for the 35 of 43, 47 to 53, 60, and 61 to 85 baseline DRSS categories, respectively (overall P = 0.002). By month 24, the proportion of eyes with DME resolution was 74.9% (221 of 295), 77.5% (299 of 386), 69.4% (109 of 157), and 78.7% (148 of 188) for the 35 of 43, 47 to 53, 60, and 61 to 85 baseline DRSS categories, respectively (overall P = 0.17).
This meta-analysis of data from patients treated with ranibizumab showed that DME resolution was faster in patients with more severe DR at baseline. However, by month 24, a similar proportion of patients achieved DME resolution, regardless of baseline DR severity. These findings may guide treatment decisions and inform patient expectations in clinical practice.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
更好地了解糖尿病性黄斑水肿（DME）患者在接受雷珠单抗治疗后糖尿病视网膜病变（DR）消退所需的时间，以及影响这一结果的因素，这将对医生和患者都有益处。本分析的目的是评估在III期临床试验中接受雷珠单抗治疗的患者首次DME消退的时间，以及基线DR严重程度对这一结果的影响。
对III期试验RIDE（NCT00473382）和RISE（NCT00473330）以及DR临床研究网络方案I（NCT00444600）、S（NCT01489189）和T（NCT01627249）的数据进行荟萃分析。
患有DME（中心子野厚度[CST]>250μm）且糖尿病视网膜病变严重程度量表（DRSS）评分在35至85之间的DR患者。
玻璃体内注射雷珠单抗。
总体评估24个月内首次DME消退（定义为CST≤250μm）的时间，并根据DRSS的基线DR严重程度类别进行评估（43分中的35分[轻度或中度非增殖性DR]、47 - 53分[中度严重或重度非增殖性DR]、60分[轻度增殖性DR]和61 - 85分[中度严重至重度增殖性DR]）。
荟萃分析纳入了777例患者。经基线CST校正后，首次DME消退的总体平均（95%置信区间）时间为6.0（5.6 - 6.4）个月。43分中的35分、47至53分、60分和61至85分基线DRSS类别的首次DME消退平均（95%CI）时间分别为7.1（6.2 - 7.9）个月、5.9（5.2 - 6.6）个月、6.0（4.8 - （此处原文有误，应为7.2））个月和4.5（3.5 - 5.5）个月（总体P = 0.002）。到第24个月时，43分中的35分、47至53分、60分和61至85分基线DRSS类别的DME消退眼比例分别为74.9%（295眼中的221眼）、77.5%（386眼中的299眼）、69.4%（157眼中的109眼）和78.7%（188眼中的148眼）（总体P = 0.17）。
对接受雷珠单抗治疗患者的数据进行的这项荟萃分析表明，基线DR越严重的患者DME消退速度越快。然而，到第24个月时，无论基线DR严重程度如何，达到DME消退的患者比例相似。这些发现可能会指导临床实践中的治疗决策并告知患者预期。
专有或商业披露信息可在参考文献之后找到。
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