Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.
Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.
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DOI：
10.1016/j.ophtha.2010.12.033
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发表时间：
2011-04
期刊：
影响因子：
13.7
通讯作者：
Diabetic Retinopathy Clinical Research Network
中科院分区：
文献类型：
--
作者：
Elman MJ;Bressler NM;Qin H;Beck RW;Ferris FL 3rd;Friedman SM;Glassman AR;Scott IU;Stockdale CR;Sun JK;Diabetic Retinopathy Clinical Research Network
报告对先前报道的一项随机试验的扩大 2 年随访，该试验评估玻璃体内注射 0.5 mg 雷珠单抗或 4 mg 曲安奈德联合局部/网格激光与单独局部/网格激光治疗糖尿病性黄斑水肿 (DME) 的疗效。多中心、随机临床试验。对 691 名参与者的 854 只眼睛进行研究，视力为 20/32 至 20/320（近似 Snellen 等效值）且 DME 涉及中央凹。继续先前报告的随机试验程序。两年就诊时的最佳矫正视力和安全性。在 2 年访视时，与假手术加即时激光组相比，雷珠单抗加即时激光组的视力字母评分相对于基线的平均变化增加了 3.7 个字母（针对多重比较调整的 95% 置信区间 [aCI]：-0.4 至 +7.7），雷珠单抗加延迟激光组增加了 5.8 个字母（95% aCI：+1.9 至 +9.8）， 曲安西龙加即时激光组差 1.5 个字母（95% aCI：-5.5 至 +2.4）。在雷珠单抗联合即时或延迟激光治疗组进行 1 至 2 年访视后，注射次数中位数分别为 2 次和 3 次（可能最多为 13 次）。在 2 年随访时，假手术 + 即时激光组中央子视野厚度≥250 μm 的眼睛百分比为 59%，雷珠单抗 + 即时激光组为 43%，雷珠单抗 + 延迟激光组为 42%，曲安西龙 + 即时激光组为 52%。没有明显的由研究治疗引起的全身事件。在雷珠单抗组中，375 名参与者中有 3 名 (0.8%) 的三只眼睛患有注射相关眼内炎，而曲安西龙+快速激光组中眼内压升高和白内障手术更为频繁。本文报告的扩展 2 年结果与之前发表的结果相似，并强化了最初报告的结论，即雷珠单抗应考虑用于 DME 患者，且其特征与本临床试验中的队列相似，包括 DME 累及黄斑中心的视力障碍。
To report expanded 2-year follow up of a previously reported randomized trial evaluating intravitreal 0.5-mg ranibizumab or 4-mg triamcinolone combined with focal/grid laser compared with focal/grid laser alone for treatment of diabetic macular edema (DME). Multicenter, randomized clinical trial. Eight hundred and fifty four study eyes of 691 participants with visual acuity of 20/32 to 20/320 (approximate Snellen equivalent) and DME involving the fovea. Continuation of procedures previously reported for the randomized trial. Best-corrected visual acuity and safety at the 2-year visit. At the 2-year visit, compared with the sham plus prompt laser group, the mean change in the visual acuity letter score from baseline was 3.7 letters greater in the ranibizumab plus prompt laser group (95% confidence interval adjusted for multiple comparisons [aCI]: -0.4 to +7.7) l, 5.8 letters greater in the ranibizumab plus deferred laser group (95% aCI: +1.9 to +9.8) and 1.5 letters worse in the triamcinolone plus prompt laser group (95% aCI : -5.5 to +2.4). After the 1- through the 2-year visit in the ranibizumab with prompt or deferred laser groups, the median numbers of injections were 2 and 3 (potential maximum of 13), respectively. At the 2-year visit, the percentages of eyes with central subfield thickness ≥250 μm were 59% in the sham + prompt laser group, 43% in the ranibizumab + prompt laser group, 42% in the ranibizumab + deferred laser group, and 52% in the triamcinolone + prompt laser group. No systemic events attributable to study treatment were apparent. Three eyes in 3 (0.8%) of 375 participants had injection-related endophthalmitis in the ranibizumab groups while elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone+prompt laser group. The expanded 2-year results reported herein are similar to results published previously and reinforce the conclusions originally reported, that ranibizumab should be considered for patients with DME and characteristics similar to the cohort in this clinical trial, including vision impairment with DME involving the center of the macula.
影响因子：
13.7
作者：
Michaelides, Michel;Kaines, Andrew;Hykin, Philip G.
通讯作者：
Hykin, Philip G.
影响因子：
13.7
作者：
Diabetic Retinopathy Clinical Research Network;Elman MJ;Aiello LP;Beck RW;Bressler NM;Bressler SB;Edwards AR;Ferris FL 3rd;Friedman SM;Glassman AR;Miller KM;Scott IU;Stockdale CR;Sun JK
通讯作者：
Sun JK