NCT00305630已完成2 期
Neovascular Age Related Macular Degeneration, Periocular Corticosteroids, and Photodynamic Therapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
研究概览
简要总结
Randomized controlled clinical trial of periocular corticosteroids as adjunctive therapy to photodynamic therapy (PDT) for patients with neovascular age-related macular degeneration (AMD). Patients undergoing PDT are randomized to either a periocular corticosteroid injection with 40 mg of triamcinolone acetonide or observation just prior to PDT. Patients are followed for 6 months. Primary outcome is leakage from choroidal neovascularization (CNV) at 3 months on fluorescein angiography.
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
- •Active choroidal neovascularization
- •Age related macular degeneration
- •Visual acuity 20/20 to 20/400
排除标准
- •Neovascular lesion >6500 microns is greatest linear diameter
- •More than one prior photodynamic therapy treatment
- •Receiving systemic corticosteroids
- •Intraocular pressure > 21 mm Hg or glaucoma medication use
- •History of glaucoma or history of ocular hypertension
结局指标
主要结局
Fluorescein leakage from choroidal neovascularization on fluorescein angiography at 3 months after randomization.
次要结局
- Safety
研究者
研究点 (2)
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