Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Mean change in visual acuity from baseline over 12 months
研究概览
简要总结
Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.
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
- None
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
- •Neovascular age-related macular degeneration patients over age 50
- •Presence of a pigment epithelial detachment on optical coherence tomography
- •Initial or recurrent disease
- •Previous treatment allowed
- •Visual acuity between Snellen 20/40 - 20/400
排除标准
- •More than three previous treatments with PDT or other radiation/laser therapy
- •Previous vitrectomy or other AMD surgical intervention
- •Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)
- •Patients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.
研究组 & 干预措施
Group1
Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.
干预措施: ranibizumab (Drug)
Group 2
Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.
干预措施: ranibizumab (Drug)
结局指标
主要结局
Mean change in visual acuity from baseline over 12 months
时间窗: 12 months
次要结局
- Time to OCT resolution of macular edema and pigment epithelial detachment(One year)
- Proportion of patients with complete resolution of PED at 6 and 12 months(12 months)
- Durability of outcome: time from last ranibizumab injection to retreatment(One year)