Doheny Eye Institute, Los Angeles, CA, USA.
Department of Ophthalmology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Eye (Lond). 2020 Mar;34(3):480-490. doi: 10.1038/s41433-019-0522-z. Epub 2019 Jul 18.
BACKGROUND/OBJECTIVES: This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO).
SUBJECTS/METHODS: Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.
Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).
Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.
背景/目的：本事后分析探讨了接受雷珠单抗治疗后残余水肿暴露与中心性糖尿病黄斑水肿（DMO）患者长期视力结局之间的关系。
受试者/方法：在Protocol I 试验中，随机分配至雷珠单抗+即刻或延迟激光治疗组且在基线和至少 1 次随访时观察到中央视网膜厚度（CRT）读数的眼（n=367），根据以下情况进行分层：1）水肿持续时间（在雷珠单抗治疗的前 52 周内，有 CRT≥250μm 的研究访视次数）；和 2）水肿程度（在雷珠单抗治疗的前 52 周内，每个研究访视时的过量 CRT[≥250μm]量，平均值）。使用多元回归分析评估残余水肿与最佳矫正视力（BCVA）之间的相关性。
在雷珠单抗治疗的前 52 周内，水肿持续时间和水肿程度与第 52、104 和 156 周的 BCVA 改善呈显著负相关。水肿最持久的眼在第 156 周时比水肿最不持久的眼（平均）多丧失（95%CI 0.1─8.7）个早期治疗糖尿病视网膜病变研究（ETDRS）字母（P=0.044）。水肿量最大的眼在第 156 周时比水肿量最小的眼（平均）多丧失（95%CI 4.0─14.5）个 ETDRS 字母（P<0.001）。
雷珠单抗治疗的前 52 周内，黄斑水肿暴露是中心性 DMO 长期视力改善的一个负面预后因素。
