Randomized clinical trial evaluating intravitreal ranibizumab or saline for vitreous hemorrhage from proliferative diabetic retinopathy.
Randomized clinical trial evaluating intravitreal ranibizumab or saline for vitreous hemorrhage from proliferative diabetic retinopathy.
复制标题
DOI：
10.1001/jamaophthalmol.2013.2015
复制
发表时间：
2013-03-01
影响因子：
8.1
通讯作者：
中科院分区：
文献类型：
--
作者：
重要性：血管内皮生长因子在增殖性糖尿病视网膜病变（PDR）中发挥作用。与单独观察相比，玻璃体内注射生理盐水可能会改善玻璃体出血患者的视力。因此，确定玻璃体内抗血管内皮生长因子是否可以降低玻璃体切除率是重要的目的：评价玻璃体内注射雷珠单抗与玻璃体内注射生理盐水相比对PDR玻璃体出血的玻璃体切除率的影响。设计：III期、双盲、随机、多中心临床试验。数据报告收集自2010年6月至2012年3月，包括16周的follow-up.SETTING：社区为基础的和学术为基础的眼科实践，专门从事视网膜diseases.PARTICIPANTS：261眼的261名研究参与者，谁是至少18岁的1型或2型糖尿病。研究眼因PDR导致的玻璃体出血妨碍了全视网膜光凝术的完成。干预：在基线和第4周和第8周，将眼随机分配到0.5 mg玻璃体内注射雷珠单抗（n = 125）或玻璃体内注射生理盐水（n = 136）。主要观察指标：16周内玻璃体切除术的累积概率。结果：16周时玻璃体切除术的累积概率为12%，而盐水组为17（差异，4%; 95%CI，-4%至13%）和完全全视网膜光凝术而不进行玻璃体切除术的患者在16周时分别为44%和31%（P = 0.05）。从基线到12周的平均（SD）视力改善分别为22（23）个字母和16（31）个字母（P = .04）。复发性玻璃体积血发生在16周内，分别为6%和17%（P = 0.01）。一只眼在盐水注射后发生眼内炎。结论和相关性：总的来说，两组16周的玻璃体切除率均低于预期。这项研究表明，对于PDR玻璃体积血患者，雷珠单抗和生理盐水之间在16周时的玻璃体切除率方面几乎不可能存在具有临床意义的差异。短期次要结局包括视力改善、全视网膜光凝完成率增加和复发性玻璃体出血率降低，表明雷珠单抗具有生物活性。长期的好处仍然未知。试验注册：该研究在www.clinicaltrials.gov上列出，标识符为NCT 00996437（网站注册日期为2009年10月14日）。
IMPORTANCE: Vascular endothelial growth factor plays a role in proliferative diabetic retinopathy (PDR). Intravitreal injection of saline has been shown potentially to lead to improved visual acuity compared with observation alone in eyes with vitreous hemorrhage. Therefore, it is important to determine if intravitreal anti-vascular endothelial growth factor can reduce vitrectomy rates (and risks associated with vitrectomy) compared with saline for vitreous hemorrhage from PDR that precludes placement or confirmation of complete panretinal photocoagulation.OBJECTIVE: To evaluate intravitreal ranibizumab compared with intravitreal saline injections on vitrectomy rates for vitreous hemorrhage from PDR.DESIGN: Phase 3, double-masked, randomized, multicenter clinical trial. Data reported were collected from June 2010 to March 2012 and include 16 weeks of follow-up.SETTING: Community-based and academic-based ophthalmology practices specializing in retinal diseases.PARTICIPANTS: Two hundred sixty-one eyes of 261 study participants, who were at least 18 years of age with type 1 or type 2 diabetes mellitus. Study eyes had vitreous hemorrhage from PDR precluding panretinal photocoagulation completion.INTERVENTION: Eyes were randomly assigned to 0.5-mg intravitreal ranibizumab (n = 125) or intravitreal saline (n = 136) at baseline and 4 and 8 weeks.MAIN OUTCOME MEASURE: Cumulative probability of vitrectomy within 16 weeks.RESULTS: Cumulative probability of vitrectomy by 16 weeks was 12% with ranibizumab vs 17% with saline (difference, 4%; 95% CI, -4% to 13%) and of complete panretinal photocoagulation without vitrectomy by 16 weeks was 44% and 31%, respectively (P = .05). The mean (SD) visual acuity improvement from baseline to 12 weeks was 22 (23) letters and 16 (31) letters, respectively (P = .04). Recurrent vitreous hemorrhage occurred within 16 weeks in 6% and 17%, respectively (P = .01). One eye developed endophthalmitis after saline injection.CONCLUSIONS AND RELEVANCE: Overall, the 16-week vitrectomy rates were lower than expected in both groups. This study suggests little likelihood of a clinically important difference between ranibizumab and saline on the rate of vitrectomy by 16 weeks in eyes with vitreous hemorrhage from PDR. Short-term secondary outcomes including visual acuity improvement, increased panretinal photocoagulation completion rates, and reduced recurrent vitreous hemorrhage rates suggest biologic activity of ranibizumab. Long-term benefits remain unknown. Whether vitrectomy rates after saline or ranibizumab injection are different than observation alone cannot be determined from this study.TRIAL REGISTRATION: The study is listed on www.clinicaltrials.gov, under identifier NCT00996437 (website registration date October 14, 2009).