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临床试验/NCT01350323
NCT01350323已完成不适用

Aqueous Humor Levels of Vascular Endothelial Growth Factor Before and After Intravitreal Bevacizumab in Type 3 Versus Type 1 and 2 Neovascularization. A Prospective, Case-control Study.

University of Molise2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2009年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
33
试验地点
2
主要终点
Aqueous VEGF concentration

研究概览

简要总结

This is a pilot, prospective, interventional, case-control study investigating aqueous levels of vascular endothelial growth factor (VEGF) in eyes with AMD-related neovascularization treated with intravitreal bevacizumab at the Medical Retina Department, University of Molise, Campobasso.

详细描述

This was a pilot, prospective, interventional, case-control study investigating aqueous levels of VEGF in eyes with AMD-related NV treated with intravitreal bevacizumab.

Classification of neovascularization was based on its anatomic localization as ascertained by multimodal imaging employing FA (fluorescein angiography), ICGA (indocyanine green angiography) and OCT (optical coherence tomography) as recently proposed by Freund et al.

Diagnostic procedures and follow-up At baseline all the patients underwent BCVA measurement using early treatment diabetic retinopathy study (ETDRS) chart at 4 meters, fundus biomicroscopy, FA, ICGA and sd-OCT. All examinations were repeated in occasion of the follow-up appointments with exception of angiographic tests.

Angiographic tests and OCTs scans were recorded using Spectralis sd-OCT (Spectralis SD-OCT, Heidelberg Engineering, Heidelberg, Germany).

CMT was calculated after acquiring a sequence of 145 horizontal sections recorded in the high-resolution mode (1024 A-scans/30 degrees) and covering an area of 20 degrees (horizontal) × 15 degrees (vertical) with a distance of ~30 µm between individual sections. On follow-up examinations, the imaging processing software allowed reevaluation at exactly the same location.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
55 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • wet age-related macular degeneration type 1, 2 or 3

排除标准

  • BCVA at baseline less than 1.0 logMAR
  • any previous treatment of the neovascular lesion
  • previous vitrectomy
  • laser coagulation within the last 3 months
  • previous participation in any studies using investigational drugs within 3months preceding day 0
  • intraocular surgery (including cataract surgery) in the study eye within 3 months preceding day 0
  • glaucoma in the study eye; diabetes mellitus
  • use of immunosuppressive drugs
  • malignant tumors of any location

结局指标

主要结局

Aqueous VEGF concentration

时间窗: Change from baseline of VEGF concentration at month 1

To establish if different types of wet-AMD were associated to different concentrations of VEGF at baseline

次要结局

  • Macular thickness assessment(Change from baseline of macular thickness at month 1)

研究者

发起方
University of Molise
申办方类型
Other

研究点 (2)

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