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临床试验/NCT04356716
NCT04356716已完成2 期

Sildenafil for Treatment of Choroidal Ischemia

Columbia University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2014年11月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
22
试验地点
1
主要终点
Change in Visual Acuity (Sildenafil Group)

研究概览

简要总结

The hypothesis of this study is to determine if there is a benefit afforded by the use of systemic Sildenafil to patients with choroidal and retinal degenerations and dystrophies, such as vitelliform degeneration, dry and reticular age-related macular degeneration (AMD) as well as patients with hereditary and acquired retinal dystrophies such as retinitis pigmentosa and central serous retinopathy.

详细描述

Age-Related Macular Degeneration (AMD) is a sight-threatening visual disturbance that affects the macula in older ages. It is irreversible if the pigment epithelium is lost (dry AMD), but wet AMD can be arrested or delayed with the use of intraocular injections of one of 3 different compounds. All three drugs are injected into the eye in minute doses of usually 0.1 ml. These are usually injected at 4 to 6 week intervals and treatment may be extended for several years. Different patterns of injection times are followed but usually are monthly for 12 or more months, or monthly for 3 months and then extended observation at one to two month intervals unless vision (visual acuity) declines or Optical Coherence Tomography-angiography (OCT-A) shows recurrence of fluid or increase in size or amount of drusen (deposits of lipofuscin) in the retina. Vitelliform macular degeneration is a disorder that causes visual loss due to drusen in the macula, which have been shown to be identical to the deposits seen in macular degeneration. The goal of therapy in this proposal is to use sildenafil to increase choroidal blood flow to treat dry AMD and slow the progression of visual loss in vitelliform and age-related dry AMD as well as other macular, retinal and choroidal degenerations and dystrophies, as well as reduce or eliminate the number of injections required by slowing down transformation of dry AMD to wet AMD in treated patients.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of retinal and choroidal degenerations (reticular or vitelliform AMD or vitelliform-type subretinal drusen) or hereditary or acquired retinal dystrophies (retinitis pigmentosa or central serous retinopathy)

排除标准

  • Diagnosis of heart disease requiring use of nitrates
  • Inability to be examined monthly or bi-monthly

研究组 & 干预措施

Standard of Care Sildenafil

Active Comparator

Medical record review for participants that are prescribed Sildenafil off-label as part of standard of care treatment for disease.

干预措施: Standard of Care Sildenafil (Other)

Sildenafil

Active Comparator

Participants are prescribed sildenafil 40-80 mg daily.

干预措施: Sildenafil (Drug)

Sildenafil

Active Comparator

Participants are prescribed sildenafil 40-80 mg daily.

干预措施: Ocular Coherence Tomography-Angiography (OCT-A) (Diagnostic Test)

Sildenafil

Active Comparator

Participants are prescribed sildenafil 40-80 mg daily.

干预措施: Visual Acuity (VA) (Other)

结局指标

主要结局

Change in Visual Acuity (Sildenafil Group)

时间窗: Up to 63 months

Patients are evaluated for progression of disease/dystrophy via visual acuity (improved/stable/worsened) and appearance of fluid layer and drusen on OCT testing.

Change in Visual Acuity (Medical Record Review Group)

时间窗: 22 months

Patients are evaluated for progression of disease/dystrophy via visual acuity (improved/stable/worsened) and appearance of fluid layer and drusen on OCT testing.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Donald Coleman

Professor of Clinical Ophthalmology

Columbia University

研究点 (1)

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