Gonzalez Victor H, Campbell Joanna, Holekamp Nancy M, Kiss Szilárd, Loewenstein Anat, Augustin Albert J, Ma Julia, Ho Allen C, Patel Vaishali, Whitcup Scott M, Dugel Pravin U
Valley Retina Institute, McAllen, Texas.
Allergan plc, Irvine, California.
Am J Ophthalmol. 2016 Dec;172:72-79. doi: 10.1016/j.ajo.2016.09.012. Epub 2016 Sep 17.
To determine whether early visual acuity response to ranibizumab in diabetic macular edema is associated with long-term outcome.
Post hoc analysis of randomized controlled trial data.
Pooled data from the ranibizumab plus prompt and deferred laser treatment arms of the Diabetic Retinopathy Clinical Research Network's Protocol I study were used to explore the relationship between early (week 12) and late (weeks 52-156) visual acuity response (mean change from baseline in best-corrected visual acuity [CFB BCVA]; categorized improvement [<5, 5-9, or ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] in BCVA).
In the analysis population (340 eyes), <5-, 5- to 9-, and ≥10-letter BCVA improvements occurred in 39.7%, 23.2%, and 37.1% of eyes, respectively, at 12 weeks, and 34.2%, 16.5%, and 49.3% of eyes at 156 weeks. Within each early BCVA response category (<5, 5-9, and ≥10 letters of improvement at 12 weeks), mean CFB BCVA at 52-156 weeks varied by <5 letters from that at 12 weeks. CFB BCVA and <5-letter improvement at 12 weeks showed significant positive and negative association, respectively, with CFB BCVA and ≥10-letter improvement at 52 and 156 weeks. Similar relationships were demonstrated in eyes with baseline BCVA <69 letters, and associations remained significant after multivariate adjustment for potential confounders.
Ranibizumab ± laser therapy resulted in similar rates (∼40%) of suboptimal (<5-letter) and pronounced (≥10-letter) BCVA improvement at 12 weeks. Eyes with suboptimal early BCVA response showed poorer long-term visual outcomes than eyes with pronounced early response (mean improvement 3.0 vs 13.8 letters at 156 weeks).
确定糖尿病性黄斑水肿患者对雷珠单抗的早期视力反应是否与长期预后相关。
对随机对照试验数据进行事后分析。
使用糖尿病视网膜病变临床研究网络方案I研究中雷珠单抗联合即刻和延迟激光治疗组的汇总数据，探讨早期（第12周）和晚期（第52 - 156周）视力反应（最佳矫正视力相对于基线的平均变化[CFB BCVA]；按BCVA改善程度分类[<5、5 - 9或≥10早期糖尿病性视网膜病变研究（ETDRS）字母]）之间的关系。
在分析人群（340只眼）中，第12周时，BCVA改善<5字母、5至9字母和≥10字母的眼分别占39.7%、23.2%和37.1%，第156周时分别占34.2%、16.5%和49.3%。在每个早期BCVA反应类别中（第12周时改善<5、5 - 9和≥10字母），第52 - 156周时的平均CFB BCVA与第12周时相差<5字母。第12周时的CFB BCVA和<5字母改善分别与第52周和156周时的CFB BCVA和≥10字母改善呈显著正相关和负相关。在基线BCVA<69字母的眼中也显示出类似的关系，在对潜在混杂因素进行多变量调整后，相关性仍然显著。
雷珠单抗±激光治疗在第12周时导致次优（<5字母）和显著（≥10字母）BCVA改善的发生率相似（约40%）。早期BCVA反应次优的眼比早期反应显著的眼长期视力预后更差（第156周时平均改善分别为3.0字母和13.8字母）。
