Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal/grid laser for diabetic macular edema in eyes also receiving panretinal photocoagulation.
Randomized trial evaluating short-term effects of intravitreal ranibizumab or triamcinolone acetonide on macular edema after focal/grid laser for diabetic macular edema in eyes also receiving panretinal photocoagulation.
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DOI：
10.1097/iae.0b013e318217d739
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发表时间：
2011-06
期刊：
影响因子：
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通讯作者：
Stockdale CR
中科院分区：
文献类型：
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作者：
Diabetic Retinopathy Clinical Research Network;Googe J;Brucker AJ;Bressler NM;Qin H;Aiello LP;Antoszyk A;Beck RW;Bressler SB;Ferris FL 3rd;Glassman AR;Marcus D;Stockdale CR
评价玻璃体内注射雷珠单抗或曲安奈德对接受局灶/格栅激光治疗的糖尿病黄斑水肿（DME）和全视网膜光凝（PRP）患者的14周疗效。345只眼睛的视力为20/320或更好，中心受累DME接受局灶/网格激光，糖尿病视网膜病变接受即时PRP，随机分配到假手术组（n=123），基线和4周时0.5 mg雷珠单抗（n=113），或基线时4 mg曲安西龙和4周时假手术组（n=109）。治疗时间由研究者决定，从14周至56周。第14周随访时，雷珠单抗组（+1 11，P<0.001）和曲安西龙组（+2 11，P<0.001）的视力字母评分较基线的平均变化（±标准差）显著优于假手术组（-4 14），反映了视网膜增厚的结果。当对研究参与者进行56周的安全性结局随访时，这些差异并没有保持。一只眼（0.9%，95% CI：0.02%-4.7%）在接受雷珠单抗治疗后发生眼内炎。假手术组、雷珠单抗组和曲安西龙组的脑血管/心血管事件发生率分别为4%、7%和3%。在接受局灶/格栅激光治疗DME和PRP的眼睛中增加1次玻璃体内曲安奈德或2次雷珠单抗注射与14周时更好的视力和黄斑水肿减少相关。本研究无法确定持续长期玻璃体内治疗是否有益。
To evaluate 14-week effects of intravitreal ranibizumab or triamcinolone in eyes receiving focal/grid laser for diabetic macular edema (DME) and panretinal photocoagulation (PRP). Three hundred and forty-five eyes with a visual acuity of 20/320 or better, center-involved DME receiving focal/grid laser, and diabetic retinopathy receiving prompt PRP were randomly assigned to sham (n=123), 0.5-mg ranibizumab (n=113) at baseline and 4 weeks, or 4-mg triamcinolone at baseline and sham at 4 weeks (n=109). Treatment was at investigator discretion from 14 to 56 weeks. Mean changes (±standard deviation) in visual acuity letter score from baseline were significantly better in the ranibizumab (+1±11, P<0.001) and triamcinolone (+2±11, P<0.001) groups compared with the sham group (-4±14) at the 14-week visit, mirroring retinal thickening results. These differences were not maintained when study participants were followed for 56 weeks for safety outcomes. One eye (0.9%, 95% CI: 0.02% to 4.7%) developed endophthalmitis after receiving ranibizumab. Cerebrovascular/cardiovascular events occurred in 4%, 7%, and 3% of the sham, ranibizumab, and triamcinolone groups, respectively. The addition of 1 intravitreal triamcinolone or 2 ranibizumab injections in eyes receiving focal/grid laser for DME and PRP is associated with better visual acuity and decreased macular edema by 14 weeks. Whether continued long-term intravitreal treatment is beneficial cannot be determined from this study.