A Randomized Observer and Subject Masked Trial Comparing the Visual Outcome After Treatment With Ranibizumab or Bevacizumab in Patients With Neovascular Age-related Macular Degeneration Multicenter Anti VEGF Trial in Austria (MANTA)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Change of visual acuity over time
研究概览
简要总结
Angiogenesis plays a key role in the development of choroidal neovascularizations (CNV) in age-related macular degeneration. Vascular endothelial growth factor (VEGF) is the most important factor involved in this angiogenetic processes in the eye. This forms the basis for new therapeutic interventions in exudative AMD. Currently two drugs have been approved by the FDA and one drug is used off-label. All these drugs are administered intravitreally. The present study aims to directly compare the effects ranibizumab and bevacizumab in a randomized controlled study in patients with neovascular AMD.
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
- Double (Participant, 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
- •Age ≥ 50 years
- •Active primary or recurrent subfoveal lesion with CNV secondary to AMD
排除标准
- •Prior treatment with any intravitreal drug in the study eye
- •Prior treatment with verteporfin photodynamic therapy in the study eye
- •Prior treatment with systemic bevacizumab
- •Prior treatment with any intravitreal durg or verteprofin photodynamic therapy in the nonstudy eye within the 3 moths before the study entry
- •Laser photocoagulation within 1 month before study entry in the study eye
- •Previous participation in any clinical trial within 1 month before the entry of the study
- •Subfoveal fibrosis or atrophy in the study eye
- •CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathologica myopia
- •Retinal pigment epithelial tear involving the macula in the study eye
- •Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss of best corrected visual acuity over the 12 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma). The decision on exclusion is to be based on the opinion of the local principal investigator.
- •Active intraocular inflammation
- •Vitreous hemorrhage in the study eye
研究组 & 干预措施
A
Intravitreal injectin of Ranibizumab (3 monthly injection followed by monthly injectins as long as required
干预措施: Ranibizumab (Drug)
B
Intravitreal injectin of Bevacizumab (3 monthly injection followed by monthly injectins as long as required
干预措施: Bevacizumab (Drug)
结局指标
主要结局
Change of visual acuity over time
时间窗: 12 months
次要结局
- Adverse events retinal thickness (OCT)(12 months)