An Active-treatment Study of the Efficacy of Ziv-aflibercept in Patients With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Kapil Kapoor
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Efficacy of study drug measured by change in best corrected visual acuity
研究概览
简要总结
This is a randomized, open-label, interventional, controlled study to determine the effects of Zaltrap on Neovascularized Wet Macular Degeneration as compared to the control anti-vascular endothelial growth factor ("anti-VEGF") injections (bevacizumab, ranibizumab, or aflibercept).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are age 50-99
- •Have neovascular Age-related Macular Degeneration ("AMD") with an eye undergoing maintenance treatment with one or more of the following anti-VEGF drugs: bevacizumab, ranibizumab, or aflibercept.
- •Have an eye undergoing treatment that is of low visual potential (20/200 Snellen equivalent or worse) and the contralateral eye must have better visual potential.
- •Are willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments.
- •Have received an intravitreal injection of one of the drugs listed above within 120 days of Day 1 of the trial.
- •Both males and females will be enrolled.
排除标准
- •Active intraocular inflammation or infection
- •History of vitreous hemorrhage within three months prior to Day 1 of the study
- •Uncontrolled ocular hypertension or glaucoma in the study eye (defined as Intraocular Pressure ("IOP") >25 mm Hg or a Cup to Disc ratio > 0.8 despite treatment with anti-glaucoma medication) or any such condition which the investigator feels may warrant a glaucoma filtering surgery during the study
- •History of stroke within the last three months prior to Day 1 of the study
- •History of myocardial infarction within the last three months prior to Day 1 of the study
- •Undergone intraocular surgery or laser treatments within the last three months,
- •Significant Epiretinal Membrane ("ERM") or Vitreomacular Traction ("VMT") causing distortion of macular anatomy
- •No use of ocular corticosteroids within the last six months and no use of systemic corticosteroids at a dose of >10 mg/day
- •Not have active malignancies within the last 12 months except appropriately treated carcinoma in situ of the cervix, melanoma, and prostate cancers treated with a curative intent
- •Inability to comply with study or follow-up procedures
- •Women who may become pregnant or lactating or intend to become pregnant during the study
- •Women who are of childbearing potential, including women who have had tubal ligation, must have a blood test within 21 days prior to Day 1 of the study. A woman is considered to not be of childbearing potential if she is postmenopausal or has undergone hysterectomy and/or bilateral oophorectomy. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
研究组 & 干预措施
Study Drug Arm
Receiving 1.25mg of 0.05mL of Ziv-aflibercept intravitreal injection every month
干预措施: Ziv-Aflibercept 25 MG/ML [Zaltrap] (Drug)
Control Arm
Receiving bevacizumab, ranibizumab, or aflibercept intravitreal injection every 5 to 12 weeks (varied intervals based on individual need for treatment)
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Efficacy of study drug measured by change in best corrected visual acuity
时间窗: 18 months
Change in Snellen equivalent letters from baseline to end of study
Efficacy of study measured by change in central foveal thickness
时间窗: 18 months
Change in microns of macular thickness as assessed by Optical Coherence Tomography ("OCT") from baseline to end of study
次要结局
- Safety of study drug as measured by number of adverse events related to study drug(2.5 years)
研究者
Kapil Kapoor
Principal Investigator
Wagner Macula & Retina Center