Jaeb Center for Health Research, Tampa, Florida.
Paducah Retinal Center, Paducah, Kentucky.
JAMA Ophthalmol. 2020 Apr 1;138(4):341-349. doi: 10.1001/jamaophthalmol.2019.6035.
Among eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity (VA), randomized clinical trial results showed no difference in VA loss between initial observation plus aflibercept only if VA decreased, initial focal/grid laser plus aflibercept only if VA decreased, or prompt aflibercept. Understanding the initial observation approach is relevant to patient management.
To assess the DRCR Retina Network protocol-defined approach and outcomes of initial observation with aflibercept only if VA worsened.
DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc secondary analyses of a randomized clinical trial of the DRCR Retina Network Protocol V that included 91 US and Canadian sites from November 2013 to September 2018. Participants were adults (n = 236) with type 1 or 2 diabetes, 1 study eye with CI-DME, and VA letter score at least 79 (Snellen equivalent, 20/25 or better) assigned to initial observation. Data were analyzed from March 2019 to November 2019.
Initial observation and follow-up with aflibercept only for VA loss of at least 10 letters from baseline at 1 visit or 5 to 9 letters at 2 consecutive visits. Follow-up occurred at 8 weeks and then every 16 weeks unless VA or optical coherence tomography central subfield thickness worsened.
Whether individuals received aflibercept.
Among 236 eyes in 236 individuals (149 [63%] male; median age, 60 years [interquartile range, 53-67 years]) randomly assigned to initial observation, 80 (34%) were treated with aflibercept during 2 years of follow-up. At 2 years, the median VA letter score was 86.0 (interquartile range, 89.0-81.0; median Snellen equivalent, 20/20 [20/16-20/25]). Receipt of aflibercept was more likely in eyes with baseline central subfield thickness at least 300 μm (Zeiss-Stratus equivalent) vs less than 300 μm (45% vs 26%; hazard ratio [HR], 1.98 [95% CI, 1.26-3.13], continuous P = .005), moderately severe nonproliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study retinopathy severity level 47) and above vs moderate nonproliferative diabetic retinopathy (retinopathy severity level 43) and below (51% vs 27%; HR, 2.22 [95% CI, 1.42-3.47], ordinal P < .001), and among participants whose nonstudy eye received DME treatment within 4 months of randomization vs not (52% vs 25%; HR, 2.55 [95% CI, 1.64-3.99], P < .001).
Most eyes managed with initial observation plus aflibercept only if VA worsened maintained good vision at 2 years and did not require aflibercept for VA loss. However, the eyes in the trial were approximately twice as likely to receive aflibercept for VA loss if they had greater baseline central subfield thickness, worse diabetic retinopathy severity level, or a nonstudy eye receiving treatment for DME.
ClinicalTrials.gov Identifier: NCT01909791.
在中心累及糖尿病性黄斑水肿（CI-DME）且视力良好的眼（VA）中，随机临床试验结果表明，在 VA 下降时，与仅初始观察加阿柏西普相比，初始局部/网格激光加阿柏西普或立即阿柏西普治疗在 VA 丧失方面无差异。了解初始观察方法与患者管理相关。
评估 DRCR 视网膜网络协议规定的方法和仅在 VA 恶化时使用阿柏西普的初始观察结果。
设计、地点和参与者：这是对 2013 年 11 月至 2018 年 9 月进行的 DRCR 视网膜网络协议 V 的随机临床试验的二次事后分析，包括来自 91 个美国和加拿大地点的 236 名参与者。参与者为患有 1 型或 2 型糖尿病、1 只研究眼伴有 CI-DME 和 VA 字母评分至少为 79（Snellen 等价物，20/25 或更好）的成年人，随机分配至初始观察。数据于 2019 年 3 月至 2019 年 11 月进行分析。
初始观察和后续治疗仅用于 VA 在一次就诊时至少下降 10 个字母或连续两次就诊时下降 5 到 9 个字母的阿柏西普。每隔 8 周进行一次随访，然后每 16 周进行一次随访，除非 VA 或光学相干断层扫描中央视网膜厚度恶化。
是否接受阿柏西普治疗。
在 236 名参与者的 236 只眼中（149[63%]为男性；中位年龄 60 岁[四分位距，53-67 岁]）随机分配至初始观察，80 只眼（34%）在 2 年随访期间接受了阿柏西普治疗。在 2 年时，VA 字母评分中位数为 86.0（四分位距，89.0-81.0；中位数 Snellen 等价物，20/20[20/16-20/25]）。与基线中央视网膜厚度至少为 300μm（蔡司-斯图尔特等效）的眼相比，基线中央视网膜厚度小于 300μm（45%比 26%；危险比[HR]，1.98[95%CI，1.26-3.13]）、中度严重非增殖性糖尿病性视网膜病变（早期糖尿病视网膜病变研究严重程度 47）及以上与中度非增殖性糖尿病性视网膜病变（严重程度 43）及以下（51%比 27%；HR，2.22[95%CI，1.42-3.47]），以及在非研究眼在随机分组后 4 个月内接受 DME 治疗的参与者中，接受阿柏西普治疗的可能性更高（52%比 25%；HR，2.55[95%CI，1.64-3.99]，P<.001）。
大多数接受初始观察加阿柏西普治疗的眼在 2 年内保持良好的视力，且不需要因 VA 丧失而使用阿柏西普治疗。然而，在试验中，如果基线中央视网膜厚度更大、糖尿病视网膜病变严重程度更高或非研究眼接受 DME 治疗，则接受阿柏西普治疗的可能性是前者的大约两倍。
ClinicalTrials.gov 标识符：NCT01909791。
