Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy.
Eye (Lond). 2012 Apr;26(4):485-93. doi: 10.1038/eye.2011.337. Epub 2012 Jan 13.
The current standard therapy for patients with diabetic macular oedema (DME)--focal/grid laser photocoagulation--usually does not improve impaired vision, and many patients lose vision despite laser therapy. Recent approval of ranibizumab by the European Medicines Agency to treat visual impairment due to DME fulfils the previously unmet medical need for a treatment that can improve visual acuity (VA) in these patients. We reviewed 1- and 2-year clinical trial findings for ranibizumab used as treatment for DME to formulate evidence-based treatment recommendations in the context of this new therapy. DME with or without visual impairment should be considered for treatment when it fulfils the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant oedema. For DME with centre involvement and associated vision loss due to DME, monthly ranibizumab monotherapy with treatment interruption and re-initiation based on VA stability is recommended. Laser therapy based on ETDRS guidelines is recommended for other forms of clinically significant DME without centre involvement or when no vision loss has occurred, despite centre involvement. Because these recommendations are based on randomised controlled trials of 1-2 years duration, guidance may need updating as long-term ranibizumab data become available and as additional therapeutic agents are assessed in clinical trials.
目前，糖尿病性黄斑水肿（DME）患者的标准治疗方法——局部/格栅激光光凝术——通常并不能改善视力受损的情况，许多患者尽管接受了激光治疗仍会丧失视力。最近，欧洲药品管理局批准雷珠单抗用于治疗 DME 引起的视力障碍，满足了此前人们对治疗方法的迫切需求，这种方法可以改善这些患者的视力。我们对雷珠单抗治疗 DME 的 1 年和 2 年临床试验结果进行了回顾，以期根据这一新疗法制定基于证据的治疗建议。DME 无论是否伴有视力损害，只要符合早期糖尿病性视网膜病变研究（ETDRS）的临床显著水肿标准，就应考虑进行治疗。对于伴有中心受累和 DME 相关视力丧失的 DME，建议每月使用雷珠单抗单药治疗，根据 VA 稳定性进行治疗中断和重新开始。对于不伴有中心受累或尽管中心受累但没有视力丧失的其他类型的临床显著 DME，建议根据 ETDRS 指南进行激光治疗。由于这些建议是基于 1 至 2 年的随机对照试验，因此可能需要更新指导，因为随着长期雷珠单抗数据的出现和其他治疗药物在临床试验中的评估，需要进行更新。
