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临床试验/NCT02218177
NCT02218177已完成不适用

Neovascular Age-related Macular Degeneration: Intraocular Inflammatory Cytokines in the Non-responder to Ranibizumab Treatment

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年8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
30
试验地点
1
主要终点
Aqueous Humour Cytokine Levels

研究概览

简要总结

The purpose of this study is to evaluate the level of cytokines (which are small proteins important in cell signalling) in eye fluid (aqueous humour) in patients with wet age related macular degeneration patients who have been treated with an injection in the eye (intravitreal injection) with a drug called ranibizumab. The level of cytokines will be compared between patients who have a good response to ranibizumab treatment and patients who are non-responsive to ranibizumab and need other forms of therapy. This knowledge will help for the future treatment and to potentially develop new medication for wet age-related macular degeneration.

详细描述

In the treatment of CNV (Choroidal NeoVascularization) secondary from AMD (Age Related Macular Degeneration) by using ranibizumab, patients who are non-responders can be found in approximately 1-10% of treatments. Thus, failure of treatment can lead to loss of vision. Growth factors and cytokines, such as vascular endothelial growth factor (VEGF), pigment epithelium derived factor (PEDF), interleukin 6 (IL-6) and placenta growth factor (PLGF) are known to play an important role in the development of CNV angiogenesis.

The rationale for conducting this study to compare VEGF, PEDF, IL-6 and PLGF cytokine levels in the aqueous humor of wet AMD and Polypoidal Choroidal Vasculopathy (PCV) patients who are poor responders to anti VEGF treatment and age-matched "good" responders to anti VEGF. Ranibizumab poor responders in AMD and PCV, who are treated with a combination of PDT/ranibizumab or intravitreous injection of aflibercept (Eyelea®, Regeneron Pharmaceuticals Inc. Tarrytown, NY, USA and Bayer, Basel, Switzerland) will be enrolled to the study. An aqueous humor sample will be obtained when patient receives intravitreal injection treatment and also at 1, 2 months follow up period. VEGF, PEDF,IL-6 and PLGF in aqueous will be analyzed and used to compare between the poor response group and age matched patient with good response to ranibizumab. Age, gender, visual acuity, central macular thickness by OCT, lesion size and fundus autofluorescence data will be collected and used to compare between these groups. Subgroup analysis of different treatment comparison with ranibizumab good responder group will be evaluated. Factors associated with the non-responders of ranibizumab will be analyzed.

Non-responders to ranibizumab treatment in AMD may have different levels and responses of inflammatory cytokines compared to the responder group. Understanding the pathogenesis and characteristic of this specific group of patients can help narrow down a specific choice of treatment and prevent the reduction of visual acuity of the patient. This study also helps identify factors associated to poor responders from ranibizumab treatment for wAMD.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Age 50 years or more
  • Ranibizumab resistance/poor responder patients in all AMD entities (typical AMD, PCV and RAP) who will be treated with intravitreous ranibizumab in combination with verteporfin photodynamic therapy
  • Ranibizumab resistance/poor responder patients in all AMD entity (typical AMD, PCV and RAP) who will be treated with intravitreous aflibercept injection
  • AMD patient who is good response to the treatment of ranibizumab (control group)

排除标准

  • Any evidence of good response in treatment of ranibizumab,
  • Uncooperative patients to intravitreal treatment
  • Patients who have clinically active ocular inflammation
  • Patients who have previous PDT treatment within 6 months
  • Patient who previously have ocular treatment of immunosuppressive agent within 3 months
  • Patient who previously have ocular treatment of steroid with in 3 months
  • Patients who are currently on systemic treatment of anti-VEGF medication or immunosuppressive agents.

研究组 & 干预措施

Non-responders receiving aflibercept therapy

Non-responders to ranibizumab who are now receiving aflibercept therapy

干预措施: Aflibercept (Drug)

Non-responders receiving PDT combo therapy

patients who are non-responders to ranibizumab who have been switched to combination photodynamic therapy (PDT)

干预措施: Combination Photodynamic Therapy (Procedure)

Responders to ranibizumab

Patients who are responders to ranibizumab and are continuing monthly injections.

干预措施: Ranibizumab (Drug)

结局指标

主要结局

Aqueous Humour Cytokine Levels

时间窗: At time of Intravitreal Injection

次要结局

  • Fluorescein Angiography Results and Indocyanine Green Angiography Results(At time of appointment)
  • Number of anti-VEGF injections before developing non-responder characteristics(At time of appointment)
  • Optical Coherence Tomography (OCT) results(At time of appointment)
  • Demographic Data(At time of appointment)
  • History of Previous Treatment(At time of appointment)

研究者

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

Wai-Ching Lam

Professor University of Toronto, Residency Program Director Dept. of Ophthalmology, Continuing Medical Education Director Dept. of Ophthalmology

University Health Network, Toronto

研究点 (1)

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