Macular Degeneration Center, Casey Eye Institute, Oregon Health & Science University, Portland, Oregon 97239-4197, USA.
Retina. 2012 Mar;32(3):417-23. doi: 10.1097/IAE.0b013e318229b0af.
To evaluate whether bromfenac eyedrops and ranibizumab intravitreal injections would provide added efficacy over ranibizumab alone.
This was a single-site, multiinvestigator, prospective, open-label, interventional, Phase II study of patients with new or recurrent exudative/neovascular age-related macular degeneration. Thirty eyes were enrolled consecutively and were randomized in a ratio of 2:1 to combination therapy with intravitreal ranibizumab and topical bromfenac, and ranibizumab alone. All patients received ranibizumab monthly therapy for 4 months then as needed monthly in accordance with standard of care. Patients receiving bromfenac self-administered 1 drop twice a day for 12 months. Patients were followed for 12 months.
There were no safety concerns with the combination therapy. No statistically significant differences were identified in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity or the number of injections required. However, the mean 12-month change in central macular thickness in the combination group was -81.56 μm while in the ranibizumab group alone the change was -42.50 μm (P = 0.03). The proportion of eyes experiencing a decrease in CMT of 50 μm or more was also significantly higher in those receiving combination therapy (P = 0.046).
This pilot study is the first to prospectively identify a biologic signal that may indicate combination therapy with an easily administered well-tolerated eyedrop and ranibizumab is efficacious for the treatment of neovascular age-related macular degeneration. Further studies are warranted to validate this finding.
评估溴芬酸钠滴眼液与雷珠单抗玻璃体腔内注射相较于单独使用雷珠单抗是否能提高疗效。
这是一项单中心、多研究者、前瞻性、开放性、干预性、Ⅱ期临床试验，纳入了患有新发或复发性渗出性/新生血管性年龄相关性黄斑变性的患者。连续纳入 30 只眼，并以 2:1 的比例随机分为联合治疗组（玻璃体腔内注射雷珠单抗联合局部滴用溴芬酸钠）和雷珠单抗单药治疗组。所有患者均接受每月一次的雷珠单抗治疗，共 4 个月，然后根据标准治疗方案按需每月治疗一次。接受溴芬酸钠治疗的患者自行每日滴眼 2 次，共 12 个月。患者随访 12 个月。
联合治疗无安全性问题。早期治疗糖尿病视网膜病变研究最佳矫正视力或所需注射次数均无统计学差异。然而，联合治疗组的平均 12 个月中央黄斑厚度变化为-81.56 μm，而雷珠单抗组单独治疗的变化为-42.50 μm（P=0.03）。接受联合治疗的患者中，CMT 减少 50 μm 或更多的比例也显著更高（P=0.046）。
这项前瞻性研究首次发现了一个生物学信号，表明使用易于管理且耐受性良好的滴眼剂联合雷珠单抗治疗新生血管性年龄相关性黄斑变性可能有效。需要进一步的研究来验证这一发现。
