Efficacy of Ranibizumab (Lucentis) in Combination With Photodynamic Therapy for Neovascular Age-Related Macular Degeneration
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Mean change from baseline at 6 months in the best corrected visual acuity (VA) score using an early treatment diabetic retinopathy study eye chart at a starting distance of 4 meters.
研究概览
简要总结
The purpose of the investigators study is to look at the visual outcomes of Ranibizumab injections in combination with photodynamic therapy for the treatment of neovascular age-related macular degeneration.
详细描述
The main cause of severe vision loss in patients with age-related macular degeneration (AMD) is the development of choroidal neovascularization (CNV). This debilitating form of AMD affects the macula lutea, the central part of the retina, which is responsible for high resolution visual acuity. Characteristic findings in neovascular AMD include the development of new, abnormal blood vessels in the choroid layer beneath the macula otherwise known as CNV.
Current treatment options for this condition have included include laser therapy, photodynamic therapy (PDT), and intraocular injections (different types of anti-vascular endothelial growth factors) alone or in combination. While current treatments were demonstrated to slow the progression of vision loss, neither therapy was shown to significantly improve visual acuity.
Given their different modes of action, it is believed that combination therapy of Ranibizumab with PDT may lead to better visual outcomes and may result in an improved effect in treating AMD and therefore may help decrease the need for monthly Ranibizumab injections. After the first injection, regardless of which group the patient has been assigned to, they will receive Ranibizumab injections at 4 week intervals if clinically indicated. The purpose of the this study is to evaluate the visual outcomes of intraocular Ranibizumab injections in combination with photodynamic therapy with verteporfin for the treatment of 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
- Single (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
- •diagnosed with any subtype of primary subfoveal or juxtafoveal choroidal neovascularization
- •must be 50 years of age or older
- •have a lesion whose total size is no more than 5400micrometres in greatest linear dimension in the study eye
- •CNV that is more than 50% obscured by blood
- •have best corrected visual acuity of 20/50-20/320 (Snellen equivalent)
- •have been assessed with the use of early treatment diabetic retinopathy study charts
排除标准
- •previous treatment (including verteporfin therapy) that could compromise an assessment of the study treatment
- •any permanent structural damage to the central fovea
研究组 & 干预措施
Pre-PDT
Participants in this group will receive an intraocular Ranibizumab injection one week prior to the first PDT with verteporfin.
干预措施: Ranibizumab (Drug)
Post-PDT
Participants in this group will receive an intraocular Ranibizumab injection one week post the first PDT with verteporfin.
干预措施: Ranibizumab (Drug)
No PDT
Participants in this group will receive an intraocular Ranibizumab injection with no accompanying PDT with verteporfin.
干预措施: Ranibizumab (Drug)
结局指标
主要结局
Mean change from baseline at 6 months in the best corrected visual acuity (VA) score using an early treatment diabetic retinopathy study eye chart at a starting distance of 4 meters.
时间窗: Monthly for a total of 12 months
次要结局
- To determine the following: 1:Proportion of subjects who loose fewer than 15 letters from baseline visual acuity at 6 months 2: Proportion of subjects with VA of 20/200 or worse 3: Proportion of subjects with VA of 20/40 or better(One year)