LUCAS. A Randomized, Prospective, Multicenter Study Comparing the Effect of Intravitreal Injection of Bevacizumab to Ranibizumab When Given to Patients With Neovascular Age-related Macular Degeneration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Mean change in VA at 1 and 2 years as measured with the ETDRS chart
研究概览
简要总结
Age-related macular degeneration (AMD) is the most common cause of blindness in individuals over 50 years of age. Bevacizumab and ranibizumab are two agents developed by the American pharmaceutical corporation Genentech, both of which inhibit blood vessel growth factors. These drugs, when injected intraocularly, reduce the pathological growth of blood vessels in the macular area of the eye. Bevacizumab (Avastin) is an antibody developed for intravenous treatment of metastasized colon cancer. Ranibizumab (Lucentis) is an antibody fragment developed from a similar antibody. It was introduced 2006 as an effective treatment for wet AMD. Treatment costs are, however, up to 50 times higher compared to use of bevacizumab. Avastin has shown similar effects to ranibizumab, and has been used off-label in many countries, both before and after Lucentis received approval. There is thus a recognized need for large randomized studies to garner proper scientific proof of Avastin's effectiveness regarding exudative AMD.
LUCAS is a randomized multicenter study, performed in Norway, comparing ranibizumab and bevacizumab use for AMD. The goal of the study was to demonstrate if the two agents were equivalent regarding both efficacy and safety. A total of 441 patients with objective evidence of wet AMD were randomized to a double-blind treatment with ranibizumab or bevacizumab over the course of 2 years. The treatment interval was determined by a "Treat and Extend" protocol.
详细描述
LUCAS (LUcentis Compared to Avastin Study) A randomized, double-blind, prospective multicenter study comparing the effect of intravitreal injection of bevacizumab (Avastin) to ranibizumab (Lucentis) when given to patients with exudative (wet) age-related macular degeneration in Norway.
Version: 4, Protocol: 166-09, EudraCT: 2008-004225-41
Purpose:
LUCAS is a prospective, randomized, multicenter study comparing the effects of intravitreal injection of bevacizumab (Avastin) with ranibizumab (Lucentis) when given to patients with exudative (wet) AMD in Norway.
The study will include 420 patients to be recruited starting March 2009. The study will continue for 2 years after completed enrollment.
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
- Quadruple (Participant, 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
- •Men and women.
- •Age ≥50 years.
- •Wet AMD in the study eye, defined as:
- •Not previously treated active choroidal neovascular membrane (CNV), including retinal angiomatous proliferation (RAP), with edema involving the fovea as demonstrated with optical coherence tomography (OCT) and fluorescein angiography (FA). FA shall not be older than 7 days at randomization.
- •Best corrected visual acuity (BCVA) in the study eye 20/25 - 20/
- •Only one eye of each study patient may be recruited into the study. If the non-study eye is being treated with intravitreal anti-VEGF therapy, or develops wet AMD, then the same drug being used in the study eye shall be used in the non-study eye. Treatment must be given double-blind in the non-study eye as well.
排除标准
- •Previous treatment of CNV in the study eye.
- •Participation in another AMD study, or use of other investigational medicines.
- •Anti-VEGF treatment in the non-study eye during the last 4 weeks.
- •Earlier or current treatment with systemic anti-VEGF drug.
- •Subretinal hemorrhage and/or fibrosis that involves ≥50 percent of the CNV lesion in the study eye.
- •CNV of other pathogenesis, such as pathologic myopia (defined as having a spherical equivalent of >8 diopters myopia) or Presumed Ocular Histoplasmosis Syndrome (POHS).
- •Presence of retinal diseases other than AMD (diabetic retinopathy, macular hole, etc) that lead to loss of visual acuity in the study eye.
- •Cataract that will presumably require operation within 2 years or other intraocular surgery or laser treatment during the last 3 months.
- •Impaired visualization of the retina (by vitreous hemorrhage, corneal dystrophy, etc.) that may hamper adequate diagnosis.
- •Intraocular pressure ≥25 mm Hg, measured before mydriasis, or uncontrolled glaucoma as evaluated by the examining ophthalmologist.
- •Active uveitis in the study eye or intraocular inflammation after use of Lucentis or Avastin in the non-study eye.
- •Infection in one or both eyes.
- •Premenopausal women who do not use appropriate birth control, or who are nursing.
- •Patients who for mental or physical reasons are unable to comply with the study's procedures,
- •Serious disease where there is a probability of death within the duration of the study.
研究组 & 干预措施
Bevacizumab
Bevacizumab 1,25 mg, intravitreal injections every 4th to 12th week
干预措施: Bevacizumab (Drug)
Bevacizumab
Bevacizumab 1,25 mg, intravitreal injections every 4th to 12th week
干预措施: Ranibizumab (Drug)
Ranibizumab
Ranibizumab 0,5 mg, intravitreal injection, every 4th to 12th week
干预措施: Bevacizumab (Drug)
Ranibizumab
Ranibizumab 0,5 mg, intravitreal injection, every 4th to 12th week
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Mean change in VA at 1 and 2 years as measured with the ETDRS chart
时间窗: After 1 and 2 years
Mean change in VA at 1 and 2 years as measured with the ETDRS chart (with a non-inferiority limit of 5 letters)
次要结局
- Number of treatments.(After 1 and 2 years)
- Macular morphology as measured by FA and OCT after 2 years.(After 2 years)
- Proportion of patients losing fewer than 15 letters on ETDRS chart(After 1 and 2 years)
- Number of non-responders.(After 2 years)
- Adverse events(2 years)