Comparative Study - Bevacizumab Versus Ranibizumab in Age Related Macular Degeneration
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )
研究概览
简要总结
To report the short term anatomic and visual acuity response after intravitreal injection of bevacizumab and ranibizumab in patients with choroidal neovascularization secondary to age-related macular degeneration.
详细描述
We conducted a retrospective study of 500 eyes with choroidal neovascularization secondary to age-related macular degeneration who were treated with at least two (initial and one month after) intravitreal injection of 1.25 mg bevacizumab or 0.5 mg ranibizumab and had a follow-up of at least 3 months. Patients underwent Snellen visual acuity testing, optical coherence tomography (OCT) imaging and ophthalmoscopic examination at baseline and follow-up visits.
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, 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
- •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 drug or verteporfin 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 pathological 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
Ranibizumab
Intravitreal injection of Ranibizumab (3 monthly injection followed by monthly injections as long as required)
干预措施: Ranibizumab (Intravitreal injection) (Drug)
Bevacizumab
Intravitreal injection of Bevacizumab (3 monthly injection followed by monthly injections as long as required)
干预措施: Bevacizumab (Intravitreal injection) (Drug)
结局指标
主要结局
Vision change Anatomical changes (Regression of NVE, CNVM, reduction in macular thickness) Electrophysiological changes (ERG, VEP )
时间窗: 6 months
次要结局
- Ocular side effects (infection, RD, IOP rise, cataract)(6 months)
研究者
Joao Nassaralla
Medical Doctor
Instituto de Olhos de Goiania