An Exploratory Study of the Safety, Tolerability and Biological Effect of Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Safety and tolerability, bioeffect
研究概览
简要总结
The purpose of this trial is to assess the ocular and systemic safety and tolerability of a single intravitreal injection of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
详细描述
This study consists of three parts, Part A, Part B and Part C. Part A is a dose escalation. Part B was terminated early. The (one) subject who received Macugen is not discussed in this website. Part C had subjects receive one of two doses of VEGF Trap (0.15 mg or 4.0 mg).
This is the first study in which human subjects received intravitreal injections of VEGF Trap in a study eye.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subfoveal CNV secondary to AMD.
- •Central retinal/lesion thickness ≥ 250µm as measured by optical coherence tomography (OCT).
- •ETDRS best-corrected visual acuity of:
- •20/40 (73 letters) or worse
- •Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.
排除标准
- •Prior treatment with VEGF Trap, bevacizumab or ranibizumab.
- •Any investigational agent within 12 weeks of Visit 2 (Day 1).
- •Presence of other causes of CNV.
- •Active ocular infection.
研究组 & 干预措施
Part A
Part A: An open label study in which six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. The total volume of each injection will be 100 μL. Enrollment in new dose levels will not begin until all patients in the preceding dose level have completed Visit 5 (Day 15).
干预措施: VEGF Trap (Drug)
Part B
Part B: A controlled, prospective, randomized, double-masked study in which up to 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive a single ITV injection of2.0 mg/eye VEGF Trap (or the MTD if reached prior to 2.0 mg) followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Enrollment into Part B will begin 2 weeks after the last subject to receive the 2.0 mg/eye dose in Part A has been observed for 15 days and it has been determined that the safety profile of VEGF Trap at this dose level is adequate to support expansion of dosing at this dose level. The dose of pegaptanib sodium will be 0.3 mg, according to the package insert.
干预措施: VEGF Trap (Drug)
Part C
Part C: A controlled, prospective, randomized, double-masked study in which approximately 30 subjects meeting eligibility criteria will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. Initiation of Part C is contingent upon the 4.0 mg dose being adequately tolerated in Part A.
干预措施: VEGF Trap (Drug)
结局指标
主要结局
Safety and tolerability, bioeffect
时间窗: From baseline to Day 43
次要结局
- The effect of VEGF Trap administration on excess central retinal/lesion thickness(From baseline to Day 43)
- Plasma levels of VEGF Trap(From baseliene to Day 43)
- Extent of CNV leakage(From baseline to Day 43)
- Anti-VEGF Trap antibodies in the systemic circulation(From baseline to Day 43)
- Best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity(From baseline to Day 43)