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[ARVO2012]南佛罗里达大学 Ivan J. Suner教授专访

  作者:  IvanJ.Suner  2012/5/11 9:31:00
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内容概要:Suner 教授:我们报道的是一个1000多例患者的多中心研究,对比了大剂量雷珠单抗与标准剂量雷珠单抗的有效性和安全性。标准剂量为每月或者按需注射0.5mg,我们增加为2 mg的剂量,研究是否更有效。

  <International OphthalmologyTimes>:Could you give us a brief summary of your study?
  Dr Suner: The study that we did is the HARBOR study and it was a large multicenter trial with over a thousand patients comparing the efficacy and safety of a higher dose of ranibizumab (Lucentis). In the trial, we compared the standard dose of 0.5mg on a monthly or as-needed basis with a 2mg dose on a monthly or as-needed basis. The goal was to see if 2mg is more efficacious on a monthly basis or as an as-needed basis compared to the standard 0.5mg on a monthly basis.

  《国际眼科时讯》:能对您的研究要点做一下简要介绍吗?
  Suner 教授:我们报道的是一个1000多例患者的多中心研究,对比了大剂量雷珠单抗与标准剂量雷珠单抗的有效性和安全性。标准剂量为每月或者按需注射0.5mg,我们增加为2 mg的剂量,研究是否更有效。

  <International OphthalmologyTimes>:What about the patient’s basic characteristics?
  Dr Suner: These were a group of patients who had wet macular degeneration as a first diagnosis. They were not diagnosed previously or treated previously so were treatment na?ve. Their mean age was 78 years old. Their median visual acuity was approximately 28 by the Snellen acuity and their lesion size was also pretty standard across all the four different groups. Their OCT characteristics were also all very similar with an OCT thickness of approximately 380 microns.

  《国际眼科时讯》:患者的基线特征是……
  Suner 教授:患者初步诊断为黄斑变性,并且在确诊之前没有接受过其他治疗,患者平均年龄为78岁,平均视敏度约为28(),OCT测量视网膜厚度为380 μm。

  <International OphthalmologyTimes>: Compared to other similar studies, were there any important differences in the patient characteristics?
  Dr Suner: They were pretty well balanced to other trials. The only difference would be that the VIEW 2 trial had a larger population of Asian patients. These were about 98% Caucasian patients.

  《国际眼科时讯》:与其他相似的研究相比,本研究中患者特征有什么重要的不同点呢?
  Suner 教授:与其他试验相比,我们的选择更加均衡,唯一的不同是,我们选择的对象人群高加索人占到98%,而VIEW 2研究多为亚洲人。

  <International OphthalmologyTimes>:Compared to other studies, your results are not the same. Is that correct?
  Dr Suner: It is very similar in that the best result was attained with ranibizumab 0.5mg monthly at a mean improvement of 10.2 letters. However, interestingly, at the higher dose, the vision was not better; so vision remained the same. The other interesting thing is that in the as-needed or PRN groups, the visual acuity is fairly good but with a lower number of injections. On the monthly injections obviously there were twelve injections per year whilst on average in the PRN group they received seven injections. There was still a very good visual outcome with an average gain of 8.2 or 8.6 letters of improvement compared to 10.2 with the monthly dosing. That is not different from CATT for example and not different from VIEW 1 and VIEW 2.

  《国际眼科时讯》:您的研究与其他研究结果并不是完全一致?
  Suner 教授:相似的地方在于,0.5mg剂量按月治疗组的视力结果最好,患者平均视力提高10.2个字母,但是有趣的是,剂量增加2mg后,视力提高并未更多。另外,按需治疗组的注射次数减少了,但患者视力非常好。与按月治疗组每年共注射12次相比,按需治疗组平均每年注射7次,但视力平均提高8.2~8.6个字母,这些结果与CATT、VIEW 1和VIEW 2的研究结果相似。

  <International OphthalmologyTimes>:What then is your opinion on the 2mg ranibizumab treatment in clinical practice?
  Dr Suner: At this point the 2mg dose did not show any greater efficacy. It was also interesting that it did not show any other safety signals of increased adverse events which we were worried about given the higher dose. But there seemed to be no increase in adverse events but also no increased efficacy on the 2mg dose compared to the 0.5mg.

  《国际眼科时讯》:您如何看待2mg雷珠单抗在临床治疗中的应用呢?
  Suner 教授:2mg的剂量没有显示有更强的有效性,但是也没有出现我们担心的不良事件增多的情况。既没有增加不良事件,也未进一步提高视力。

  <International OphthalmologyTimes>:As for recalcitrant neovascular AMD or low responders, what is your current management strategy?
  Dr Suner: Right now for those who are non-responders, the management strategy for many people is to perform indocyanine green angiography looking for a component of polypoidal which might respond to other therapies including Visudyne photodynamic therapy. Also switching medications from ranibizumab to perhaps aflibercept or bevacizumab is a strategy as well. In terms of these non-responders, we usually characterize them by having fluid despite continuous treatment but I think with treatment every month the numbers of those not responding is quite low so the need to switch medications is also quite low.

  《国际眼科时讯》:对于难治性新生血管性AMD或对药物反应性差的患者,您的治疗策略是什么呢?
  Suner 教授:对于这些患者,建议做吲哚青绿血管造影,寻找息肉状脉络膜血管病变,这可能会对其他治疗有反应,如光动力治疗。并且,适当更换药物,如雷珠单抗换为阿帕西普或贝伐单抗等。对于无反应者,我们通常认为其特点是尽管接受持续治疗,但仍有视网膜内或视网膜下的液体。但是我认为接受按月治疗后仍无反应的患者数量非常少,因此实际上需要更换药物的患者极少。

  <International OphthalmologyTimes>:Besides 2mg ranibizumab, what is your opinion about combination therapy?
  Dr Suner: Monotherapy with anti-VEGF therapy is I think excellent and probably the standard of care right now. However if there is non-response then I think at that point we pursue it further with imaging and ICG specifically, and in those patients photodynamic therapy is very efficacious in controlling the residual fluid so combination therapy does apply. But I think the gold standard is still monotherapy with an anti-VEGF agent.

  《国际眼科时讯》:关于联合治疗,您有什么建议呢?
  Suner 教授:单用抗血管内皮生长因子(VEGF)药物的治疗效果出色,甚至我们将其视作目前的标准治疗方法。但是对于药物反应性差的患者,我们应进行眼底成像,特别是ICG,其中使用光动力药物治疗很有效的患者,即能有效减少残余液体的患者,可以考虑PDT和雷珠单抗联合应用。但我还是认为金标准仍是抗VEGF单药治疗。


 
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