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Five-Year Outcomes after Initial Aflibercept, Bevacizumab, or Ranibizumab Treatment for Diabetic Macular Edema (Protocol T Extension Study).
Ophthalmology ( IF 13.1 ) Pub Date : 2020-03-29 , DOI: 10.1016/j.ophtha.2020.03.021
Adam R Glassman 1 , John A Wells 2 , Kristin Josic 1 , Maureen G Maguire 3 , Andrew N Antoszyk 4 , Carl Baker 5 , Wesley T Beaulieu 1 , Michael J Elman 6 , Lee M Jampol 7 , Jennifer K Sun 8
Affiliation  

Purpose

Assess follow-up treatment and clinical outcomes at 5 years in eyes initially treated with anti-VEGF therapy for center-involved diabetic macular edema (CI-DME) in a 2-year randomized clinical trial.

Design

Multicenter cohort study.

Participants

Participants with diabetic macular edema (DME) and visual acuity (VA) 20/32 to 20/320 enrolled in DRCR.net Protocol T with visits 5 years after randomization (3 years after Protocol T completion).

Methods

Participants were assigned randomly to aflibercept, bevacizumab, or ranibizumab with protocol-defined follow-up and re-treatment for 2 years. Thereafter, participants were managed at clinician discretion and recalled for a 5-year visit.

Main Outcome Measures

Anti-vascular endothelial growth factor (VEGF) treatment, VA letter score, and central subfield thickness (CST).

Results

Sixty-eight percent (317/463) of eligible participants completed the 5-year visit. Between years 2 and 5, 68% (217/317) of study eyes received at least 1 anti-VEGF treatment (median, 4; interquartile range [IQR], 0–12). At 5 years, mean VA improved from baseline by 7.4 letters (95% confidence interval [CI], 5.9–9.0) but decreased by 4.7 letters (95% CI, 3.3–6.0) between 2 and 5 years. When baseline VA was 20/50 to 20/320, mean 5-year VA was 11.9 letters (95% CI, 9.3–14.5) better than baseline but 4.8 letters (95% CI, 2.5–7.0) worse than 2 years. When baseline VA was 20/32 to 20/40, mean 5-year VA was 3.2 letters (95% CI, 1.4–5.0) better than baseline but 4.6 letters (95% CI, 3.1–6.1) worse than 2 years. Mean CST decreased from baseline to 5 years by 154 μm (95% CI, 142–166) and was stable between 2 and 5 years (−1 μm; 95% CI, −12 to 9).

Conclusions

Among the two-thirds of eligible Protocol T participants who completed a 5-year visit, mean VA improved from baseline to 5 years without protocol-defined treatment after follow-up ended at 2 years. Although mean retinal thickness was similar at 2 and 5 years, mean VA worsened during this period. Additional investigation into strategies to improve long-term outcomes in eyes with DME seems warranted to determine if VA can be better maintained with different management approaches.



中文翻译:

初始阿柏西普、贝伐单抗或雷珠单抗治疗糖尿病黄斑水肿后的五年结果(方案 T 扩展研究)。

目的

在一项为期 2 年的随机临床试验中,评估最初用抗 VEGF 疗法治疗中心涉及的糖尿病性黄斑水肿 (CI-DME) 的眼睛的 5 年随访治疗和临床结果。

设计

多中心队列研究。

参与者

糖尿病性黄斑水肿 (DME) 和视力 (VA) 20/32 至 20/320 的参与者参加了 DRCR.net 方案 T,并在随机化 5 年后(方案 T 完成后 3 年)进行了访问。

方法

参与者被随机分配到阿柏西普、贝伐单抗或雷珠单抗组,并按照协议规定的随访和再治疗 2 年。此后,参与者由临床医生自行决定管理并召回 5 年访问。

主要观察指标

抗血管内皮生长因子 (VEGF) 治疗、VA 字母评分和中心亚区厚度 (CST)。

结果

68% (317/463) 的合格参与者完成了为期 5 年的访问。在第 2 年和第 5 年之间,68% (217/317) 的研究眼睛接受了至少 1 次抗 VEGF 治疗(中位数,4;四分位距 [IQR],0-12)。5 年时,平均 VA 比基线提高了 7.4 个字母(95% 置信区间 [CI],5.9-9.0),但在 2 年和 5 年之间降低了 4.7 个字母(95% CI,3.3-6.0)。当基线 VA 为 20/50 至 20/320 时,平均 5 年 VA 比基线好 11.9 个字母(95% CI,9.3-14.5),但比 2 年差 4.8 个字母(95% CI,2.5-7.0)。当基线 VA 为 20/32 至 20/40 时,平均 5 年 VA 比基线好 3.2 个字母(95% CI,1.4-5.0),但比 2 年差 4.6 个字母(95% CI,3.1-6.1)。平均 CST 从基线到 5 年降低了 154 μm(95% CI,142-166),并且在 2 到 5 年之间保持稳定(-1 μm;95% CI,-12-9)。

结论

在完成 5 年随访的三分之二符合条件的方案 T 参与者中,平均 VA 从基线改善至 5 年,随访结束后 2 年没有方案定义的治疗。尽管平均视网膜厚度在 2 年和 5 年相似,但在此期间平均 VA 恶化。对改善 DME 眼长期结果的策略的进一步研究似乎有必要确定是否可以通过不同的管理方法更好地维持 VA。

更新日期:2020-03-29
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