Persistent Macular Thickening Following Intravitreous Aflibercept, Bevacizumab, or Ranibizumab for Central-Involved Diabetic Macular Edema With Vision Impairment A Secondary Analysis of a Randomized Clinical Trial
Persistent Macular Thickening Following Intravitreous Aflibercept, Bevacizumab, or Ranibizumab for Central-Involved Diabetic Macular Edema With Vision Impairment A Secondary Analysis of a Randomized Clinical Trial
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DOI：
10.1001/jamaophthalmol.2017.6565
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发表时间：
2018-03-01
影响因子：
8.1
通讯作者：
Wells, John A., III
中科院分区：
文献类型：
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作者：
Bressler, Neil M.;Beaulieu, Wesley T.;Wells, John A., III
重要性通过24周的抗血管内皮生长因子治疗，持续性中枢受累的糖尿病黄斑水肿（DME）的患病率及其长期结果可能与治疗有关。目的评估随机分配至2.0 mg阿柏西普、1.25 mg贝伐单抗或0.3 mg雷珠单抗治疗后持续至少24周的DME的结果。和参与者临床试验的事后分析，DRCR。net Protocol T在660名参与者中的546名中（82.7%）符合本研究的入选标准。干预6个月玻璃体内抗血管内皮生长因子注射（除非注射3 - 5次后成功）;根据方案需要，随后注射或局部/网格激光以达到稳定性。主要结果和测量持续DME至24周，2年内慢性持续性DME的可能性，以及至少10个字母（>= 2线）的视力增加或丧失。结果参与者的平均年龄为60岁，363人（66.5%）为白色，251人（46.0%）为女性。贝伐单抗治疗24周后持续性DME的发生率（118/180 [65.6%]）高于阿柏西普（60/190 [31.6%]）或雷珠单抗（73/176 [41.5%]）（阿柏西普vs贝伐单抗，P <0.001;雷珠单抗vs贝伐单抗，P <0.001;阿柏西普vs雷珠单抗，P = 0.05）。在24周内持续性DME的患眼中（n = 251），2年内慢性持续性DME的发生率在阿柏西普组为44.2%，贝伐单抗组为68.2%（阿柏西普vs贝伐单抗，P = 0.03），雷珠单抗组为54.5%（阿柏西普vs雷珠单抗，P = 0.41;贝伐单抗vs雷珠单抗，P = 0.16）。在24周内持续性DME的患眼中，2年内持续性DME与无持续性DME的患眼相比基线增加至少10个字母的比例分别为62%（29只眼）与63%（30只眼）阿柏西普组为51%，贝伐单抗组为54%，雷珠单抗组为44%，雷珠单抗组为65%。只有3只眼睛慢性持续性DME失去了至少10 letters.CONCLUSIONS和相关性持久性DME更可能与贝伐单抗比阿柏西普或雷珠单抗。在持续性DME的患眼中，分配至贝伐珠单抗组的患眼比分配至阿柏西普组的患眼更可能发生慢性持续性DME。这些结果表明，无论是否给予抗血管内皮生长因子药物或DME持续2年，视力均有显著提高，视力丧失的风险很小。当考虑在3次或更多次注射后转换治疗持续性DME时，需要谨慎;改善可能是由于继续治疗而不是转换治疗。
IMPORTANCE Prevalence of persistent central-involved diabetic macular edema (DME) through 24 weeks of anti-vascular endothelial growth factor therapy and its longer-term outcomes may be relevant to treatment.OBJECTIVE To assess outcomes of DME persisting at least 24 weeks after randomization to treatment with 2.0-mg aflibercept, 1.25-mg bevacizumab, or 0.3-mg ranibizumab.DESIGN, SETTING, AND PARTICIPANTS Post hoc analyses of a clinical trial, the DRCR. net Protocol T among 546 of 660 participants (82.7%) meeting inclusion criteria for this investigation.INTERVENTIONS Six monthly intravitreous anti-vascular endothelial growth factor injections (unless success after 3 to 5 injections); subsequent injections or focal/grid laser as needed per protocol to achieve stability.MAIN OUTCOMES AND MEASURES Persistent DME through 24 weeks, probability of chronic persistent DME through 2 years, and at least 10-letter (>= 2-line) gain or loss of visual acuity.RESULTS The mean age of participants was 60 years, 363 (66.5%) were white, and 251 (46.0%) were women. Persistent DME through 24 weeks was more frequent with bevacizumab (118 of 180 [65.6%]) than aflibercept (60 of 190 [31.6%]) or ranibizumab (73 of 176 [41.5%]) (aflibercept vs bevacizumab, P < .001; ranibizumab vs bevacizumab, P < .001; and aflibercept vs ranibizumab, P = .05). Among eyes with persistent DME through 24 weeks (n = 251), rates of chronic persistent DME through 2 years were 44.2% with aflibercept, 68.2% with bevacizumab (aflibercept vs bevacizumab, P = .03), and 54.5% with ranibizumab (aflibercept vs ranibizumab, P = .41; bevacizumab vs ranibizumab, P = .16). Among eyes with persistent DME through 24 weeks, proportions with vs without chronic persistent DME through 2 years gaining at least 10 letters from baseline were 62% of 29 eyes vs 63% of 30 eyes (P = .88) with aflibercept, 51% of 70 vs 54% of 31 (P = .96) with bevacizumab, and 44% of 38 vs 65% of 29 (P = .10) with ranibizumab. Only 3 eyes with chronic persistent DME lost at least 10 letters.CONCLUSIONS AND RELEVANCE Persistent DME was more likely with bevacizumab than with aflibercept or ranibizumab. Among eyes with persistent DME, eyes assigned to bevacizumab were more likely to have chronic persistent DME than eyes assigned to aflibercept. These results suggest meaningful gains in vision with little risk of vision loss, regardless of anti-vascular endothelial growth factor agent given or persistence of DME through 2 years. Caution is warranted when considering switching therapies for persistent DME following 3 or more injections; improvements could be owing to continued treatment rather than switching therapies.