一项关于全身性免疫抑制治疗年龄相关性黄斑变性伴脉络膜新生血管的随机先导研究。
A randomized pilot study of systemic immunosuppression in the treatment of age-related macular degeneration with choroidal neovascularization.
机构信息
Laboratory of Immunology, National Eye Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.
出版信息
Retina. 2010 Nov-Dec;30(10):1579-87. doi: 10.1097/IAE.0b013e3181e7978e.
BACKGROUND
Age-related macular degeneration remains the leading cause of irreversible blindness in the United States and the developed world. Intravitreal injections of anti–vascular endothelial growth factor (VEGF) medications have become standard of care for the treatment of the wet form of the disease. Recent reports have demonstrated an association with various immune factors. We aimed to investigate the effect of immunosuppressive therapy in the clinical course of the wet form of the disease. We compared anti-VEGF therapy plus one of three systemic immunosuppressive therapies versus anti-VEGF therapy alone for recurrent choroidal neovascularization associated with age-related macular degeneration.
METHODS
This was a pilot, Phase I/II, prospective, randomized, unmasked, single-center trial. Patients with subretinal exudation secondary to recurrent choroidal neovascularization associated with age-related macular degeneration were included in the study. Patients were randomized to 1 of 3 systemic arms immunosuppressive agents (daclizumab, rapamycin, or infliximab) for 6 months plus intraocular anti-VEGF therapy if indicated, compared with a group who received only anti-VEGF therapy if indicated.
RESULTS
The number of anti-VEGF injections per group, visual acuity, retinal thickness, and safety measures were assessed in all groups. Thirteen patients were randomized; comparing anti-VEGF injections before and during the study, a decrease in the number of injections from 0.73 injections per month to 0.42 for daclizumab and from 0.67 to 0.34 for sirolimus was seen, while no apparent decrease was seen for either infliximab or observation. Visual acuities were maintained in all groups.
CONCLUSION
These preliminary data suggest that some immunosuppressive agents given systemically can alter the clinical course of the wet form of the disease and support the notion that more definitive clinical trials of immune mediation of age-related macular degeneration are indicated.
背景
年龄相关性黄斑变性仍然是美国和发达国家导致不可逆性失明的主要原因。玻璃体内注射抗血管内皮生长因子（VEGF）药物已成为治疗湿性疾病的标准治疗方法。最近的报告表明，它与各种免疫因素有关。我们旨在研究免疫抑制疗法对湿性疾病临床病程的影响。我们比较了抗 VEGF 治疗联合三种全身免疫抑制疗法中的一种与单独抗 VEGF 治疗用于治疗与年龄相关性黄斑变性相关的复发性脉络膜新生血管形成。
方法
这是一项前瞻性、随机、非盲、单中心的 I/II 期试验。研究纳入了因与年龄相关性黄斑变性相关的复发性脉络膜新生血管形成而导致的视网膜下渗出的患者。患者被随机分为三组全身免疫抑制药物（达珠单抗、雷帕霉素或英夫利昔单抗）治疗 6 个月联合眼内抗 VEGF 治疗（如果需要），与仅在需要时接受抗 VEGF 治疗的一组进行比较。
结果
所有组均评估了每组的抗 VEGF 注射次数、视力、视网膜厚度和安全性措施。13 名患者被随机分组；与研究前相比，比较抗 VEGF 注射次数，达珠单抗组从每月 0.73 次减少到 0.42 次，雷帕霉素组从 0.67 次减少到 0.34 次，而英夫利昔单抗或观察组则没有明显减少。所有组的视力均保持不变。
结论
这些初步数据表明，一些全身给予的免疫抑制剂可以改变湿性疾病的临床病程，并支持需要更明确的年龄相关性黄斑变性免疫介导的临床试验的观点。
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