Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,208
- 试验地点
- 51
- 主要终点
- Change From Baseline in Visual-acuity Score (Continuous)
研究概览
简要总结
The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule.
A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.
详细描述
Age related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. More than 1.6 million people in the US currently have one or both eyes affected by the advanced stage of AMD.
Lucentis® is the most effective treatment for neovascular AMD studied to date. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several investigators began evaluating intravitreal Avastin® for the treatment of CNV. Given its molecular similarity to Lucentis, its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative to Lucentis®.
In addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy.
Only a single eye in each patient was analyzed.
At the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.
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 (Care Provider, Investigator, Outcomes Assessor)
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
- •Active, subfoveal choroidal neovascularization (CNV)
- •Fibrosis < 50% of total lesion area
- •Visual acuity (VA) 20/25-20/320
- •Age ≥ 50 yrs
- •At least 1 drusen (>63μ) in either eye or late AMD in fellow eye
排除标准
- •Previous treatment for CNV in study eye
- •Other progressive retinal disease likely to compromise VA
- •Contraindications to injections with Lucentis or Avastin
研究组 & 干预措施
1
Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
干预措施: ranibizumab (Drug)
2
Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
干预措施: bevacizumab (Drug)
3
Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
干预措施: ranibizumab (Drug)
4
Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
干预措施: bevacizumab (Drug)
结局指标
主要结局
Change From Baseline in Visual-acuity Score (Continuous)
时间窗: Baseline and 1 Year
Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline. In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.
次要结局
- Fluid on Optical Coherence Tomography(at 1 Year)
- Area of Lesion Change From Baseline(Baseline and 1 Year)
- Number of Treatments(1 Year)
- Dye Leakage on Angiogram(at 1 Year)
- Visual-acuity Score and Snellen Equivalent (Frequency)(at 1 Year)
- Visual-acuity Score and Snellen Equivalent (Continuous)(at 1 Year)
- Change in Diastolic Blood Pressure From Baseline(Baseline and 1 Year)
- Change From Baseline Visual-acuity Score (Frequency)(Baseline and 1 Year)
- Total Thickness Change From Baseline at Fovea(Baseline and 1 Year)
- Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea(Baseline and 1 Year)
- Average Cost of Drug/Patient(at 1 Year)
- Total Thickness at Fovea(at 1 Year)
- Area of Lesion(at 1 Year)
- Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea(at 1 Year)
- Change in Systolic Blood Pressure From Baseline(Baseline and 1 Year)