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Lapses in Care Among Patients Assigned to Ranibizumab for Proliferative Diabetic Retinopathy: A Post Hoc Analysis of a Randomized Clinical Trial
JAMA Ophthalmology ( IF 7.8 ) Pub Date : 2021-12-01 , DOI: 10.1001/jamaophthalmol.2021.4103
Maureen G Maguire 1 , Danni Liu 2 , Susan B Bressler 3 , Scott M Friedman 4 , Michele Melia 2 , Cynthia R Stockdale 2 , Adam R Glassman 2 , Jennifer K Sun 5, 6 ,
Affiliation  

Importance The follow-up schedule for individuals with eyes treated with anti–vascular endothelial growth factor agents for proliferative diabetic retinopathy (PDR) requires that patients return frequently for monitoring and repeated treatment. The likelihood that a patient will comply should be a consideration in choosing a treatment approach.

Objective To describe completion of scheduled examinations among participants assigned to intravitreous injections of ranibizumab for PDR in a multicenter randomized clinical trial.

Design, Setting, and Participants This post hoc analysis evaluates data from a randomized clinical trial conducted at 55 US sites among 305 adults with proliferative diabetic retinopathy enrolled between February and December 2012. Both eyes were enrolled for 89 participants (1 eye to each study group), with a total of 394 study eyes. The final 2-year visit was completed in January 2015. Data were analyzed from April 2019 to July 2021.

Interventions Ranibizumab injections for PDR or macular edema.

Main Outcomes and Measures A long lapse in care of 8 or more weeks past a scheduled examination, dropout from follow-up, visual acuity at 5 years.

Results Among 170 participants, the median age was 51 years, and 44.7% were female. Through 5 years of follow-up, 94 of 170 participants (55.3%) had 1 or more long lapse in care. Median time to the first long lapse was 210 weeks, and 69 of 94 participants (73.4%) returned for examination after the first long lapse. Fifty of 170 participants (29.4%) dropped out of follow-up by 5 years. Among the 120 participants who completed the 5-year examination, median change from baseline in visual acuity was −2 letters for participants who had 1 or more long lapse compared with +5 letters for those without a long lapse (P = .02). After multivariable adjustment, the odds ratio (95% CI) for baseline associations with 1 or more long lapse was 1.21 (1.03-1.43) for each 5-letter decrement in visual acuity score, 2.19 (1.09-4.38) for neovascularization of the disc and elsewhere, and 3.48 (1.38-8.78) for no prior laser treatment for diabetic macular edema.

Conclusions and Relevance Over 5 years, approximately half of the participants assigned to ranibizumab for PDR had a long lapse in care despite substantial effort by the DRCR Retina Network to facilitate timely completion of examinations. The likelihood of a long lapse in care during long-term follow-up needs to be considered when choosing treatment for PDR.

Trial Registration ClinicalTrials.gov Identifier: NCT01489189



中文翻译:

分配给 Ranibizumab 治疗增殖性糖尿病视网膜病变的患者的护理失误:一项随机临床试验的事后分析

重要性 用抗血管内皮生长因子药物治疗增殖性糖尿病视网膜病变 (PDR) 的患者的随访计划要求患者经常返回以进行监测和重复治疗。在选择治疗方法时,应考虑患者顺从的可能性。

目的 描述在一项多中心随机临床试验中分配给玻璃体内注射雷珠单抗治疗 PDR 的参与者完成预定检查的情况。

设计、设置和参与者 这项事后分析评估了 2012 年 2 月至 2012 年 12 月期间在美国 55 个地点进行的一项随机临床试验的数据,该试验涉及 305 名患有增殖性糖尿病视网膜病变的成年人。89 名参与者的两只眼睛都被纳入(每个研究组各一只眼) ),共有 394 只研究眼。最后一次为期 2 年的访问于 2015 年 1 月完成。数据分析时间为 2019 年 4 月至 2021 年 7 月。

干预 PDR 或黄斑水肿的雷珠单抗注射。

主要结果和措施 超过预定检查 8 周或更长时间的护理长期失灵,随访中途退出,视力 5 年。

结果 170 名参与者中,中位年龄为 51 岁,女性占 44.7%。通过 5 年的随访,170 名参与者中有 94 名 (55.3%) 有 1 次或更长的长期护理失误。第一次长时间间隔的中位时间为 210 周,94 名参与者中有 69 人 (73.4%) 在第一次长时间间隔后返回检查。170 名参与者中有 50 名(29.4%)在 5 年内退出随访。在完成 5 年检查的 120 名参与者中,有 1 次或以上长期失准的参与者的视力与基线的中位数变化为 -2 个字母,而没有长期失明的参与者则为 +5 个字母(P = .02)。多变量调整后,基线与 1 次或更多长时间间隔的比值比 (95% CI) 对于视力评分每下降 5 个字母为 1.21 (1.03-1.43),对于椎间盘新生血管形成为 2.19 (1.09-4.38)和其他地方,以及 3.48 (1.38-8.78),因为之前没有对糖尿病性黄斑水肿进行激光治疗。

结论和相关性 5 年多来,尽管 DRCR 视网膜网络为促进及时完成检查做出了巨大努力,但分配到雷珠单抗治疗 PDR 的参与者中,大约有一半的参与者出现了长时间的护理失误。在选择 PDR 的治疗方法时,需要考虑长期随访期间护理长期失效的可能性。

试验注册 ClinicalTrials.gov 标识符:NCT01489189

更新日期:2021-12-15
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