Subtenon Injections of Ranibizumab Arrest Growth in Early Recurrent Pterygium

L. Rose, J. Byrd, Yousuf Qaseem
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引用次数: 6

Abstract

Importance: Currently the only treatment for recurrent pterygium is surgery. This is a phase 1 trial investigating ranibizumab as a medical treatment for recurrent pterygium. Objective: To assess the safety and efficacy of subtenon Ranibizimab for recurrent pterygia. Design: Subjects with recurrent pterygium received subtenon ranibizumab and were followed for 1 year. Safety parameters were measured. Photographs were taken and quantitatively analyzed to measure the short-term (2 months) and long-term (5–26 months) response to treatment. Setting: University of New Mexico Eye Clinic. Participants: Eight subjects with recurrent pterygia. Interventions: Subtenon delivery of 0.5 to 2 mg of ranibizumab, at day 0, month 1, and month 2. Main Outcome Measures: Safety parameters included visual acuity, intraocular pressure, and assessment of ocular surface. Efficacy was assessed by comparing photographs taken at day 0 with a short-term follow-up photograph taken at month 2 and a long-term follow-up image taken at the final patient visit (range 5–26 months). Quantitative analysis of photographs was performed to measure vascularity in the treated zone. Results: Four subjects had an arrest of pterygium growth with a visual reduction in vascularity and a quantitative reduction in the area of vascularization (average vascularized area in short-term follow-up images was 51% of the baseline photos at day 0, and in the long-term photos was 36% of day 0). The other four subjects had a less marked reduction in their vascularity in the short-term photos (69% of their baseline photos). This resulted in two subjects withdrawing from the study early. Long-term quantitative analysis for the two remaining “nonresponders,” who completed the study, showed an average vascularized area that was 71% of that in their baseline photos. The long-term photos in these subjects did not appear to have a clinically relevant difference from the short-term photos. Conclusions: In half of the subjects, subtenon ranibizumab appeared to arrest growth. Although the response is variable, this may warrant the drug's use when attempting to control growth of recurrent pterygia, and may prevent consecutive surgery for some patients.
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注射雷尼单抗抑制早期复发性翼状胬肉的生长
重要性:目前治疗复发性翼状胬肉的唯一方法是手术。这是一项研究雷尼单抗作为复发性翼状胬肉药物治疗的1期试验。目的:评价雷尼匹单抗治疗复发性翼状胬肉的安全性和有效性。设计:复发性翼状胬肉患者接受雷尼单抗治疗,随访1年。测量了安全参数。拍摄照片并定量分析,以衡量短期(2个月)和长期(5-26个月)对治疗的反应。单位:新墨西哥大学眼科诊所。参与者:8例复发性翼状胬肉患者。干预措施:Subtenon在第0天、第1个月和第2个月给药0.5 - 2mg雷尼单抗。主要结局指标:安全参数包括视力、眼压和眼表评估。通过比较第0天拍摄的照片、第2个月拍摄的短期随访照片和最后一次患者就诊时拍摄的长期随访照片(范围5-26个月)来评估疗效。对照片进行定量分析,以测量治疗区的血管状况。结果:4名受试者的翼状胬肉生长停止,并伴有视觉上的血管减少和血管面积的定量减少(短期随访图像中的平均血管面积为第0天基线照片的51%,长期随访图像中的平均血管面积为第0天的36%)。其他4名受试者在短期照片中的血管减少不太明显(为基线照片的69%)。这导致两名受试者提前退出研究。对其余两名完成研究的“无反应者”进行的长期定量分析显示,他们的血管化面积平均为基线照片的71%。这些受试者的长期照片似乎与短期照片没有临床相关差异。结论:在一半的受试者中,雷尼单抗subtenon似乎可以抑制生长。虽然反应是可变的,但这可能是在试图控制复发性翼状胬肉生长时使用该药物的理由,并且可能防止某些患者连续手术。
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