Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.
Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema.
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DOI：
10.1016/j.ophtha.2010.02.031
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发表时间：
2010-06
期刊：
影响因子：
13.7
通讯作者：
Sun JK
中科院分区：
文献类型：
--
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
评价玻璃体内0.5 mg雷珠单抗或4 mg曲安奈德联合局灶/格栅激光与单独局灶/格栅激光治疗糖尿病性黄斑水肿（DME）的比较。多中心、随机临床试验。691名受试者的854只研究眼的视力（近似Snellen等效值）为20/32至20/320，DME累及中央凹。将眼睛随机分配至假注射+即时激光（n=293）、0.5 mg雷珠单抗+即时激光（n=187）、0.5 mg雷珠单抗+延迟（≥24周）激光（n=188）或4 mg曲安西龙+即时激光（n=186）。再治疗遵循一种由基于网络的实时数据输入系统提供便利的算法。1年时的最佳矫正视力和安全性。1年平均变化雷珠单抗+快速激光治疗组的视力字母评分较基线显著更高（±标准差）（+9 11，P<0.001）和雷珠单抗+延迟激光组（+9 12，P<0.001），但与假手术+即时激光组（+3 13）相比，曲安西龙+即时激光组（+4 13，P=0.31）没有。曲安西龙+即时激光组的平均中央子野厚度的减少与两个雷珠单抗组相似，并且大于假手术+即时激光组。在基线时的假晶状体眼子集（n=273）中，曲安西龙+快速激光组的视力改善似乎与雷珠单抗组相当。无明显可归因于研究治疗的全身性事件。雷珠单抗组有3只眼（0.8%）发生注射相关性眼内炎，而曲安西龙+快速激光组的眼内压升高和白内障手术更常见。2年视力结局与1年结局相似。玻璃体内雷珠单抗联合即时或延迟激光治疗累及中央黄斑的DME比单纯即时激光治疗有效至少1年。本研究中使用的雷珠单抗虽然不常见与眼内炎相关，但应考虑用于DME患者和与本临床试验中特征相似的患者。在人工晶状体眼中，玻璃体内曲安奈德+即时激光似乎比单独激光更有效，但通常会增加眼内压升高的风险。
Evaluate 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. A total of 854 study eyes of 691 participants with visual acuity (approximate Snellen equivalent) of 20/32 to 20/320 and DME involving the fovea. Eyes were randomized to sham injection + prompt laser (n=293), 0.5 mg ranibizumab + prompt laser (n=187), 0.5 mg ranibizumab + deferred (≥24 weeks) laser (n=188), or 4 mg triamcinolone + prompt laser (n=186). Retreatment followed an algorithm facilitated by a web-based, real-time data-entry system. Best-corrected visual acuity and safety at 1 year. The 1-year mean change (±standard deviation) in the visual acuity letter score from baseline was significantly greater in the ranibizumab + prompt laser group (+9±11, P<0.001) and ranibizumab + deferred laser group (+9±12, P<0.001) but not in the triamcinolone + prompt laser group (+4±13, P=0.31) compared with the sham + prompt laser group (+3±13). Reduction in mean central subfield thickness in the triamcinolone + prompt laser group was similar to both ranibizumab groups and greater than in the sham + prompt laser group. In the subset of pseudophakic eyes at baseline (n=273), visual acuity improvement in the triamcinolone + prompt laser group appeared comparable to that in the ranibizumab groups. No systemic events attributable to study treatment were apparent. Three eyes (0.8%) had injection-related endophthalmitis in the ranibizumab groups, whereas elevated intraocular pressure and cataract surgery were more frequent in the triamcinolone + prompt laser group. Two-year visual acuity outcomes were similar to 1-year outcomes. Intravitreal ranibizumab with prompt or deferred laser is more effective through at least 1 year compared with prompt laser alone for the treatment of DME involving the central macula. Ranibizumab as applied in this study, although uncommonly associated with endophthalmitis, should be considered for patients with DME and characteristics similar to those in this clinical trial. In pseudophakic eyes, intravitreal triamcinolone + prompt laser seems more effective than laser alone but frequently increases the risk of intraocular pressure elevation.
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影响因子：
4.1
作者：
Arevalo, J. F.;Maia, M.;Sanchez, J. G.
通讯作者：
Sanchez, J. G.
DOI：
10.1007/s00417-008-0914-4
发表时间：
2008-12-01
影响因子：
2.7
作者：
Moradian, Siamak;Ahmadieh, Hamid;Azarmina, Mohsen
通讯作者：
Azarmina, Mohsen
影响因子：
13.7
作者：
Martidis, A;Duker, JS;Baumal, C
通讯作者：
Baumal, C
影响因子：
--
作者：
Sabet-Peyman, E. Jason;Heussen, Florian M. A.;Do, Diana V.
通讯作者：
Do, Diana V.
影响因子：
4.2
作者：
Beck, RW;Moke, PS;Kraker, RT
通讯作者：
Kraker, RT