Indocyanine Green Angiography-Guided Photodynamic Therapy for Treatment of Retinal Capillary Abnormalities.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement and/or stabilization of disease.
研究概览
简要总结
The purpose of this research is to use an approved drug(Visudyne) for neovascular age-related macular degeneration, which is essentially choroidal neovascularization for permeability and vascular proliferation for the retinal circulation, to treat another permeable abnormality - retinal capillary abnormalities - located eccentric to the central portion of the macula or in the foveal region.
详细描述
The study will include 30 patients who were diagnosed with retinal capillary abnormalities and include 2 follow-up visits at 6 and 12 months post-procedure to determine if the treatment has been effective in treating their disorder. It is anticipated that approximately half of the patients will require an additional treatment. Patients will be enrolled from our patient population and be 50 years of age and older, male or female. Pregnant women or women of normal child bearing age will be excluded since there are no adequate and well-controlled studies on the use of photodynamic therapy in pregnant women. Any retinal vascular abnormality that has a standard of care method of treatment will also be excluded from the study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Individuals that are 50 years of age and older.
- •Patients with retinal capilary abnormalities/vascular diseases such as macular telangiectasia type I and type II, retinal arteriolar macroanurysms, and retinal angiomous proliferation (RAP).
- •Patients with diabetic retinopathy and branch retinal vein occlusions
- •Other patients who are non-responders to approved treatment methods
排除标准
- •Patients whose diseases have approved methods of treatment.
- •Pregnant women or women of normal child bearing age.
研究组 & 干预措施
Visudyne
Visudyne half fluence- 1 treatment with the possibility of a second treatment.
干预措施: Visudyne (Drug)
结局指标
主要结局
Improvement and/or stabilization of disease.
时间窗: 1-2 years
The drug, approved for are-related macular degeneration should also prove effective for other permeable conditions, such as retinal capillary/vascular abnormalities that lead to macular edemas such as macular telangiectasia type I and type II, retinal arteriolar macroanurysms, and retinal angiomatous proliferation (RAP), which is a variant of neovascular age-related macular degeneration. These diseases currently have no available approved alternative treatment.
次要结局
未报告次要终点