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临床试验/NCT02015351
NCT02015351已完成不适用

Intravitreal Bevacizumab for the Treatment of Choroidal Neovascularization in Vogt-Koyanagi-Harada Disease - A Prospective Study

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Visual Acuity change

研究概览

简要总结

Efficacy of monthly intravitreal anti-vascular endothelial growth factor (VEGF) associated to systemic immunosuppression in patients with Vogt-Koyanagi-Harada Disease and choroidal neovascularization. Minimum follow-up 12 months. Endpoints: 6 and 12 months of follow-up. Outcome measures: improvement of VA, decrease in central foveal thickness as measured by Optical Coherence Tomography (OCT) and absence of intra/subretinal fluid.

详细描述

Choroidal neovascularization (CNV) in Vogt-Koyanagi-Harada (VKH) disease is associated with poor visual prognosis. Several treatments have been suggested, though there is still no standard therapy. CNV diagnosis will be based on fundus biomicroscopy (presence of serous retinal detachment with or without retinal hemorrhages), fluorescein angiography (FA) (presence of early phase hyperfluorescence with late phase leakage) and OCT findings (hyperreflective lesion related to a CNV complex with serous foveal detachment or intraretinal fluid with increased foveal thickness). Inflammation will be considered active if anterior chamber cells or optic disc leakage in FA is observed. Each patient will undergo a complete clinical exam, including best corrected visual acuity (VA) (Snellen charts). Once active CNV is identified, a loading dose of 3 injections of IV bevacizumab will be proceeded monthly and systemic immunosuppression will be introduced or intensified. After the first 3 injections, the patient will be clinically examined and OCT will be proceeded monthly. The persistence of intra/subretinal fluid in the OCT will indicate one more IV bevacizumab injection. Immunosuppression status evaluation will be done at 3, 6, 9 and 12 months of follow up and intensification will be done if inflammatory signs or persistence of intraretinal fluid is observed. Presence of intra/subretinal fluid and manual measurement of retina central foveal thickness (CFT) will be proceeded in horizontal scan by the same examiner.

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
10 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with Vogt-Koyanagi-Harada disease based on Revised Diagnostic Criteria presented by the International Committee on VKH disease in 2001;
  • Presence of choroidal neovascularization identified by fundus biomicroscopy, fluorescein angiography and OCT.

排除标准

  • Media opacities precluding posterior segment exam, ametropia over 5 dioptries, glaucoma (defined as a disease with characteristic damage at the optic nerve or characteristic visual field defect with compatible nerve fiber layer lesion), Age related Macular degeneration, impossibility to increase immunosuppression.

研究组 & 干预措施

Anti-VEGF and Immunosuppression

Experimental

Bevacizumab: Dosage 1.25mg/0.05ml; Frequency monthly injections; Duration at least 3 months.

Immunosuppression: cyclosporine and/or azathioprine

干预措施: bevacizumab (Drug)

结局指标

主要结局

Visual Acuity change

时间窗: 6 months

Visual Acuity will be measured using Snellen charts with best refraction by the same examiner.

Change in central foveal thickness

时间窗: 6 months

Central foveal thickness will be measured manually using the caliper by the same examiner. Measurements will be proceeded from the Bruch's membrane till the internal limiting membrane and comparison with previous measurement will be done.

Presence or absence of intra/subretinal fluid in OCT

时间窗: 6 months

OCT will be analyzed at 6 and 12 months for the presence of intra or subretinal fluid.

次要结局

  • Visual Acuity change(12 months)
  • Change in Central Foveal Thickness(12 months)
  • Presence or Absence of Intra/Subretinal fluid in OCT(12 months)

研究者

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

Joyce Hisae Yamamoto

MD, PhD, Coordinator of the Uveitis Service

University of Sao Paulo

研究点 (1)

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