Bressler Neil M, Odia Isoken, Maguire Maureen, Glassman Adam R, Jampol Lee M, MacCumber Mathew W, Shah Chirag, Rosberger Daniel, Sun Jennifer K
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Editor, JAMA Ophthalmology.
JAMA Ophthalmol. 2019 Sep 1;137(9):977-985. doi: 10.1001/jamaophthalmol.2019.1963.
The determination of optical coherence tomography (OCT) central subfield thickness (CST) is an objective measure, and visual acuity (VA) is a subjective measure. Therefore, using OCT CST changes as a surrogate for VA changes in diabetic macular edema seems reasonable. However, studies suggest that change in OCT CST following anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema is correlated with changes in VA but varies substantially among individuals, and so may not be a good surrogate for changes in VA.
To determine associations between changes in VA and changes in OCT CST across 3 anti-VEGF agents (aflibercept, bevacizumab, or ranibizumab) used in a randomized clinical trial for diabetic macular edema.
DESIGN, SETTING, AND PARTICIPANTS: Post hoc analyses were conducted of DRCR Retina Network Protocol T among 652 of 660 participants (98.8%) meeting inclusion criteria for this investigation. The study was conducted between August 22, 2012, and September 23, 2015. The post hoc data collection and analysis were performed from May 29 to July 11, 2018.
Six monthly intravitreous anti-VEGF injections (unless success was achieved after 3-5 months) were administered; subsequent injections or focal/grid laser photocoagulation treatments were given as needed per protocol to achieve stability.
Association between changes in VA letter score with changes in CST at 12, 52, and 104 weeks after randomization to aflibercept, bevacizumab, or ranibizumab.
Of the 652 participants, 304 were women (46.6%); median age was 61 years (interquartile range, 54-67 years). The correlation between CST and VA at the follow-up visits was 0.24 (95% CI, 0.16-0.31) in 616 patients at 12 weeks, 0.31 (95% CI, 0.24-0.38) in 609 patients at 52 weeks, and 0.23 (95% CI, 0.15-0.31) in 566 patients at 104 weeks. The correlation coefficients of change in VA vs change in OCT CST for these time intervals were 0.36 (95% CI, 0.29-0.43) at 12 weeks, 0.36 (95% CI, 0.29-0.43) at 52 weeks, and 0.33 (95% CI, 0.26-0.41) at 104 weeks.
Changes in CST appear to account for only a small proportion of the total variation in changes in VA. These findings do not support using changes in OCT CST as a surrogate for changes in VA in phase 3 clinical trials evaluating anti-VEGF for diabetic macular edema or as a guide to inform the physician or patient about changes in VA after anti-VEGF treatment.
ClinicalTrials.gov identifier: NCT01627249.
光学相干断层扫描（OCT）中央子场厚度（CST）的测定是一种客观测量方法，而视力（VA）是一种主观测量方法。因此，将OCT CST变化作为糖尿病性黄斑水肿中VA变化的替代指标似乎是合理的。然而，研究表明，抗血管内皮生长因子（抗VEGF）治疗糖尿病性黄斑水肿后OCT CST的变化与VA变化相关，但个体间差异很大，因此可能不是VA变化的良好替代指标。
确定在一项糖尿病性黄斑水肿随机临床试验中使用的3种抗VEGF药物（阿柏西普、贝伐单抗或雷珠单抗）中，VA变化与OCT CST变化之间的关联。
设计、设置和参与者：对DRCR视网膜网络方案T进行事后分析，660名参与者中有652名（98.8%）符合本研究的纳入标准。该研究于2012年8月22日至2015年9月23日进行。事后数据收集和分析于2018年5月29日至7月11日进行。
每月进行6次玻璃体内抗VEGF注射（除非在3 - 5个月后取得成功）；后续注射或根据方案按需进行局部/格栅激光光凝治疗以实现病情稳定。
随机接受阿柏西普、贝伐单抗或雷珠单抗治疗后12、52和104周时，VA字母评分变化与CST变化之间的关联。
652名参与者中，304名是女性（46.6%）；中位年龄为61岁（四分位间距，54 - 67岁）。在616例患者中，12周时CST与VA的相关性为0.24（95%CI，0.16 - 0.31），609例患者中52周时为0.31（95%CI，0.24 - 0.38），566例患者中104周时为0.23（95%CI，0.15 - 0.31）。这些时间间隔内VA变化与OCT CST变化的相关系数在12周时为0.36（95%CI，0.29 - 0.43），52周时为0.36（95%CI，0.29 - 0.43），104周时为0.33（95%CI，0.26 - 0.41）。
CST变化似乎仅占VA变化总变异的一小部分。这些发现不支持在评估抗VEGF治疗糖尿病性黄斑水肿的3期临床试验中，将OCT CST变化作为VA变化的替代指标，也不支持作为告知医生或患者抗VEGF治疗后VA变化的指南。
ClinicalTrials.gov标识符：NCT01627249。
