Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.
Panretinal Photocoagulation vs Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy: A Randomized Clinical Trial.
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泛视光凝与用于增生性糖尿病性视网膜病的静脉内ranibizumab：一项随机临床试验。
DOI：
10.1001/jama.2015.15217
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发表时间：
2015-11-24
期刊：
影响因子：
--
通讯作者：
Beck RW
中科院分区：
文献类型：
--
作者：
Writing Committee for the Diabetic Retinopathy Clinical Research Network;Gross JG;Glassman AR;Jampol LM;Inusah S;Aiello LP;Antoszyk AN;Baker CW;Berger BB;Bressler NM;Browning D;Elman MJ;Ferris FL 3rd;Friedman SM;Marcus DM;Melia M;Stockdale CR;Sun JK;Beck RW
全视网膜光凝（PRP）是减少增殖性糖尿病视网膜病变（PDR）严重视力丧失的标准治疗方法。然而，PRP会损害视网膜，导致周围视力丧失或加重糖尿病性黄斑水肿（DME）。比较雷尼单抗与PRP治疗PDR。随机临床试验（55个美国站点）评估雷尼单抗与PRP在视力结果方面的非劣效性；2012年2月至12月，305名患有PDR的成年人入组（平均年龄52岁，44%女性，52%白人）。89名参与者的两只眼睛共有394只研究眼睛。最后一次为期两年的访问于2015年1月完成。雷尼单抗组（N=191眼）：玻璃体内注射0.5 mg雷尼单抗，如果治疗失败，给予PRP；雷尼单抗治疗二甲醚。PRP组（N=203眼）：PRP；雷尼单抗治疗二甲醚。初级：2年的平均视力变化（5个字母的非劣效性界限；意向治疗分析）。其次：视力曲线下面积、周边视野丧失、DME发展、新生血管形成、玻璃体切除和安全性。雷尼单抗组2年平均视力改善为+2.8，而PRP组为+0.2（差异为+2.2,95%可信区间[CI]: - 0.5至+5.0，非劣效性P<0.001）。治疗组2年的平均视力曲线下面积差异为+4.2 （95% CI: +3.0 ~ +5.4， P<0.001）。PRP组与雷尼单抗组相比，视野敏感度下降更严重（平均dB差372；95% CI: 213至531，P<0.001），玻璃体切除术更频繁（15%对4%，差9%，95% CI: 4%至15%，P<0.001）， DME发展更频繁（28%对9%，差19%，95% CI: 10%至28%，P<0.001）。2年无活动性或退行性新生血管形成的眼睛相似（35%[雷尼单抗组]与30% [PRP组]，差异3%，95% CI: - 7%至12%，P=0.58）。1只眼（雷尼单抗组）发生眼内炎。两组间主要心血管事件发生率无显著差异。在患有PDR的眼睛中，使用雷尼单抗治疗两年后的视力不低于（不差于）PRP治疗。虽然需要更长期的随访，但对于PDR患者，雷尼单抗可能是一种合理的治疗选择，至少可以持续2年。
Panretinal photocoagulation (PRP) is standard treatment for reducing severe visual loss from proliferative diabetic retinopathy (PDR). However, PRP can damage the retina, resulting in peripheral vision loss or worsening diabetic macular edema (DME). Compare ranibizumab versus PRP for PDR. Randomized clinical trial (55 U.S. sites) assessing non-inferiority of ranibizumab compared with PRP for vision outcomes; 305 adults with PDR enrolled February-December 2012 (mean age 52, 44% female, 52% white). Both eyes enrolled for 89 participants totaling 394 study eyes. The final 2-year visit was completed January 2015. Ranibizumab group (N=191 eyes): intravitreous 0.5-mg ranibizumab and, PRP if treatment failed; ranibizumab as needed for DME. PRP group (N=203 eyes): PRP; ranibizumab as needed for DME. Primary: mean visual acuity change at 2 years (5-letter non-inferiority margin; intention-to-treat analysis). Secondary: visual acuity area under the curve, peripheral visual field loss, DME development, neovascularization, vitrectomy, and safety. Mean visual acuity letter improvement at 2 years was +2.8 in the ranibizumab group versus +0.2 in the PRP group (difference +2.2, 95% confidence interval [CI]: −0.5 to +5.0, non-inferiority P<0.001). Mean treatment group difference in visual acuity area under the curve over 2 years was +4.2 (95% CI: +3.0 to +5.4, P<0.001). Visual field sensitivity loss was worse (mean dB difference 372; 95% CI: 213 to 531, P<0.001), vitrectomy more frequent (15% versus 4%, difference 9%, 95% CI: 4% to 15%, P<0.001), and DME development more frequent (28% versus 9%, difference 19%, 95% CI: 10% to 28%, P<0.001) in the PRP versus ranibizumab group, respectively. Eyes with neither active nor regressed neovascularization at 2 years was similar (35% [ranibizumab group] versus 30% [PRP group], difference 3%, 95% CI: −7% to 12%, P=0.58). One eye (ranibizumab group) developed endophthalmitis. No significant differences between groups in rates of major cardiovascular events were identified. Among eyes with PDR, treatment with ranibizumab resulted in visual acuity that was non-inferior to (not worse than) PRP treatment at two years. Although longer term follow-up is needed, ranibizumab may be a reasonable treatment alternative, at least through 2 years, for patients with PDR.
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DOI：
10.1097/iae.0b013e318217d739
发表时间：
2011-06
期刊：
Retina (Philadelphia, Pa.)
影响因子：
--
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
通讯作者：
Stockdale CR
影响因子：
8.1
作者：
通讯作者：
--
影响因子：
8.1
作者：
Bressler, Susan B.;Edwards, Allison R.;Chalam, Kakarla V.;Bressler, Neil M.;Glassman, Adam R.;Jaffe, Glenn J.;Melia, Michele;Saggau, David D.;Plous, Oren Z.
通讯作者：
Plous, Oren Z.
影响因子：
4.2
作者：
Beck, RW;Moke, PS;Kraker, RT
通讯作者：
Kraker, RT
影响因子：
13.7
作者：
Korobelnik, Jean-Francois;Do, Diana V.;Brown, David M.
通讯作者：
Brown, David M.