Schmidt-Erfurth U, Wolf S
Department of Ophthalmology, Universitätsklinik fur Augenheilkunde und Optometrie, University of Vienna, AKH Vienna, Währinger Gürtel 18-20, A-1090 Vienna, Austria.
Br J Ophthalmol. 2008 Dec;92(12):1628-35. doi: 10.1136/bjo.2007.135277. Epub 2008 Sep 4.
To evaluate safety of same-day administration of verteporfin and ranibizumab.
Prospective, open-label, multicentre study; patients with predominantly classic (n = 13) or occult (n = 19) choroidal neovascularisation secondary to age-related macular degeneration received standard-fluence verteporfin at baseline and months 3, 6 and 9, based on fluorescein angiography (FA). Ranibizumab 0.5 mg was administered at baseline and months 1, 2 and 3.
The incidence of severe vision loss (best-corrected visual acuity (BCVA) loss > or = 30 letters; primary safety assessment).
No severe vision loss due to ocular inflammation or uveitis occurred. One patient had moderate vision loss (BCVA loss > or = 15 letters). Three patients had mild/moderate uveitis. Two serious ocular adverse events occurred (retinal pigment epithelial tear and moderate BCVA decrease). No systemic adverse events occurred. At 9 months, all lesions were inactive with no recurrent leakage on FA and optical coherence tomography; macular oedema and subretinal fluid resolved. The mean BCVA measured at 2 m improved by 6.9 letters at 4 months and 2.4 letters at 9 months. CONCLUSIONS/APPLICATION TO CLINICAL PRACTICE: Same-day verteporfin and ranibizumab was safe and not associated with severe vision loss or severe ocular inflammation. Lesions stabilized, with minimal treatment required after month 3.
评估维替泊芬与雷珠单抗同日给药的安全性。
前瞻性、开放标签、多中心研究;年龄相关性黄斑变性继发的主要为典型性(n = 13)或隐匿性(n = 19)脉络膜新生血管患者,根据荧光素血管造影(FA)在基线、第3、6和9个月接受标准剂量的维替泊芬治疗。在基线、第1、2和3个月给予0.5 mg雷珠单抗。
严重视力丧失的发生率(最佳矫正视力(BCVA)下降≥30个字母;主要安全性评估)。
未发生因眼部炎症或葡萄膜炎导致的严重视力丧失。1例患者出现中度视力丧失(BCVA下降≥15个字母)。3例患者出现轻度/中度葡萄膜炎。发生2例严重眼部不良事件(视网膜色素上皮撕裂和BCVA中度下降)。未发生全身不良事件。在9个月时,所有病变均无活性,FA和光学相干断层扫描未见复发性渗漏;黄斑水肿和视网膜下液消退。在2 m处测量的平均BCVA在4个月时提高了6.9个字母,在9个月时提高了2.4个字母。结论/临床实践应用:维替泊芬与雷珠单抗同日给药安全,与严重视力丧失或严重眼部炎症无关。病变稳定,3个月后所需治疗最少。