NCT02569892已完成不适用
Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in Macular Drusen Volume
研究概览
简要总结
This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
- •Previous macular laser treatment.
- •Any previous ocular condition that may be associated with a risk of developing macular oedema.
- •Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).
- •Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
- •Important known allergies to sodium fluorescein dye used in angiography.
- •Ocular or periocular infections.
- •Planned intra-ocular surgery within one year.
- •Patient is unavailable for follow-up visits.
结局指标
主要结局
Change in Macular Drusen Volume
时间窗: baseline, 6, 12, and 24 months
Mean change in macular drusen volume as measured on high-resolution spectral domain ocular coherence tomography (SD-OCT)
次要结局
- Change in Visual Acuity(baseline, 6, 12, and 24 months)
- Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)(2 years)
研究者
Steven R. Sanislo
Professor
Stanford University
研究点 (2)
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