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临床试验/NCT00802126
NCT00802126已完成1 期

Efficacy of Combining Intravitreal Bevacizumab With Photodynamic Therapy Using Reduced Light Fluence Rate in Choroidal Neovascularization Secondary to Pathologic Myopia.

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
16
试验地点
1
主要终点
BCVA improved

研究概览

简要总结

The purpose of this study is to report the treatment effect and safety of combined intravitreal bevacizumab (IVB) and photodynamic therapy (PDT) with verteporfin using a reduced (RF) light fluence rate, in choroidal neovascularization (CNV) secondary to pathologic myopia.

详细描述

In this retrospective interventional case series, 16 patients with myopic CNV were included. All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25 J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active leaking of CNV occurred 90 to 120 days after the treatment.

Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were recorded. Follow-up evaluations were carried out for 12 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
35 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Myopic CNV, CNV leakage

排除标准

  • CNV not associated with high myopia
  • No activity of CNV

研究组 & 干预措施

Bevacizumab and verteporfin

Experimental

干预措施: Combination therapy "IVB + rf-PDT" (Drug)

结局指标

主要结局

BCVA improved

时间窗: 6 months

次要结局

  • no CNV leakage(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chiosi Flavia

Chiosi Flavia

University of Campania "Luigi Vanvitelli"

研究点 (1)

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