Southeastern Retina Associates, P.C., Knoxville, Tennessee, USA.
Retina. 2011 Jun;31(6):1009-27. doi: 10.1097/IAE.0b013e318217d739.
To evaluate 14-week effects of intravitreal ranibizumab or triamcinolone in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation.
Three hundred and forty-five eyes with a visual acuity of 20/320 or better, center-involved diabetic macular edema receiving focal/grid laser, and diabetic retinopathy receiving prompt panretinal photocoagulation were randomly assigned to sham (n = 123), 0.5-mg ranibizumab (n = 113) at baseline and 4 weeks, and 4-mg triamcinolone at baseline and sham at 4 weeks (n = 109). Treatment was at investigator discretion from 14 weeks to 56 weeks.
Mean changes (±SD) 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 those in 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% confidence interval, 0.02%-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 injection or 2 intravitreal ranibizumab injections in eyes receiving focal/grid laser for diabetic macular edema and panretinal photocoagulation 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.
评估玻璃体腔内注射雷珠单抗或曲安奈德对接受局灶/格栅激光治疗糖尿病性黄斑水肿和全视网膜光凝的患眼的 14 周疗效。
345 只视力为 20/320 或更佳、中心性糖尿病性黄斑水肿接受局灶/格栅激光治疗、糖尿病性视网膜病变接受即刻全视网膜光凝的患眼,随机分为假手术组(n = 123)、治疗组(n = 113),在基线和第 4 周时分别给予 0.5mg 雷珠单抗,在基线和第 4 周时给予 4mg 曲安奈德;治疗组(n = 109),在 14 周至 56 周期间,根据研究者的判断进行治疗。
与假手术组(基线时视力字母评分平均变化为-4 ± 14)相比,雷珠单抗组(+1 ± 11;P < 0.001)和曲安奈德组(+2 ± 11;P < 0.001)在第 14 周时视力字母评分的平均变化明显更好,反映了视网膜增厚的结果。当对研究参与者进行 56 周的安全性随访时,这些差异不再维持。接受雷珠单抗治疗的 1 只眼(0.9%;95%置信区间,0.02%-4.7%)发生眼内炎。假手术组、雷珠单抗组和曲安奈德组的脑血管/心血管事件发生率分别为 4%、7%和 3%。
在接受局灶/格栅激光治疗糖尿病性黄斑水肿和全视网膜光凝的患眼中,单次玻璃体腔内注射曲安奈德或两次玻璃体腔内注射雷珠单抗治疗与 14 周时更好的视力和黄斑水肿减轻相关。从本研究中无法确定是否继续长期玻璃体内治疗是否有益。