Comparison of Pharmacokinetics of and Effect on Systemic Vascular Endothelial Growth Factor (VEGF) Levels Over Time of Intravitreal Ranibizumab and Bevacizumab and Aflibercept in Age Related Macular Degeneration Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in serum and plasma levels of free Vascular Endothelial Growth Factor
研究概览
简要总结
To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.
详细描述
To determine plasma levels of VEGF and serum Pharmacokinetic (PK) levels after varying lengths of time following intravitreal injection with Avastin, Lucentis, or Eylea in exudative macular degeneration. Patients will be tested while following a normal course of treatment in our institute. All screenings and testing will be conducted in three study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide written informed consent for participation in this study.
- •Adults ≥ 50 years of age with exudative macular degeneration treated with Avastin, Lucentis, or Eylea in previously determined time intervals exclusive to a single anti-VEGF treatment type for not than three months.
- •CONTROL GROUP: Age matched control group with no previously diagnosed exudative macular degeneration will also be enrolled.
- •Provide signed informed consent.
排除标准
- •Uncontrolled blood pressure (defined as systolic > 160mm Hg or Diastolic > 95mm Hg while patient is sitting)
- •Uncontrolled diabetes mellitus defined by Hemoglobin A1c (HbA1C > 12% at screening)
- •Concomitant ocular or systemic administration of drugs that may interfere with or potentiate the mechanism of action of anti-VEGF medications.
- •Previous administration of systemic anti-angiogenic medications within 3 months
- •Participation in a simultaneous medical investigation or trial.
- •Treatment within 2 months with anti-VEGF agent in the fellow eye or anticipated need for further treatment during the study.
- •Patients with any cancer diagnosis in remission for less than five years with the exception that patients with skin cancers, basal cell or squamous cell, treated exclusively or topical treatment will be allowed.
- •Female patients who have not reached menopause, defined as cessation of menses for a minimum of twelve months with no perimenopausal symptoms.
- •Patients who have significant wound healing during the trial.
- •Patients with a history of vitrectomy in the study eye.
- •patients with uncontrolled psoriasis, rheumatoid arthritis, osteoarthritis.
研究组 & 干预措施
Group 1 Lucentis 4 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
干预措施: Ranibizumab (Drug)
Group 2 Avastin 4 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
干预措施: Bevacizumab (Drug)
Group 8 Avastin 8 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
干预措施: Bevacizumab (Drug)
Group 3 Eylea 4 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
干预措施: Aflibercept (Drug)
Group 4 Lucentis 6 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
干预措施: Ranibizumab (Drug)
Group 5 Avastin 6 weeks
Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.
干预措施: Bevacizumab (Drug)
Group 6 Eylea 6 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
干预措施: Aflibercept (Drug)
Group 7 Lucentis 8 weeks
Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.
干预措施: Ranibizumab (Drug)
Group 9 Eylea 8 weeks
Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.
干预措施: Aflibercept (Drug)
Group 10 Control Group no treatment
Blood samples will be collected from patients who are not receiving anti-VEGF treatment.
干预措施: Control Group (Other)
结局指标
主要结局
Change in serum and plasma levels of free Vascular Endothelial Growth Factor
时间窗: up to 8 weeks
Serum and plasma levels of free vascular endothelial growth factor will be measured up to 8 weeks following the standard of care treatment.
次要结局
- Change in Serum drug levels in nanomoles (nM) units following treatment(8 weeks)
- Amount of fluid (cubic mm) as measured by Ocular Coherence Tomography in the contralateral eye will be correlated with systemic Vascular Endothelial Growth Factor levels(8 weeks)
研究者
Ronald E. Frenkel, MD
Prinicipal Investigator
East Florida Eye Institute