A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 36
- 主要终点
- Mean Change of CR/LT From Baseline at Week 12
研究概览
简要总结
This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD.
The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
详细描述
This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.
After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.
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
- Triple (Participant, Care Provider, Investigator)
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 (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
- •Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.
排除标准
- •History of any vitreous hemorrhage within 4 weeks prior to Day
- •Significant subfoveal atrophy or scarring.
- •Prior treatment with the following in the study eye:
- •Subfoveal thermal laser therapy.
- •Submacular surgery or other surgical intervention for the treatment of AMD.
- •Extrafoveal laser coagulation treatment within 12 weeks prior to Day
- •Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
- •Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
- •Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
- •Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.
- •Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).
- •Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.
结局指标
主要结局
Mean Change of CR/LT From Baseline at Week 12
时间窗: Baseline and at Week 12
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.
次要结局
- Mean Percent Change of CR/LT From Baseline at Week 12(Baseline and at Week 12)
- Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12(Baseline and at week 12)
- Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12(At Week 12)