Effects of Sildenafil on Choroidal Thickness in Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in Choroidal Thickness as Assessed on Enhanced-Depth Imaging Optical Coherence Tomography (EDI-OCT)
研究概览
简要总结
Choroidal thinning has been hypothesized to partake in the pathogenesis of age-related macular degeneration (AMD), but it is not known if increasing choroidal thickness may potentially alter the disease course. Past studies have shown that a single dose of the phosphodiesterase type-5 inhibitor sildenafil citrate can increase choroidal thickness in young healthy patients. The investigators hypothesize that sildenafil may also increase choroidal thickness in eyes with AMD and perhaps potentially reduce AMD progression. Alternatively, if sildenafil has minimal effect on choroidal thickness in eyes in patients with AMD, such results may suggest that choroidal vascular compliance or stiffness is reduced in this condition. Patients seen at the Duke Eye Center with a diagnosis of AMD or age-matched control subjects with no macular pathology will be administered a single 100mg oral dose of sildenafil citrate (Viagra®; Pfizer), and undergo EDI-OCT imaging before and after treatment. Images obtained will be used to measure choroidal thickness, as well as central macular thickness (CMT) and macular volume (MV). Choroidal thickness changes after a single-dose sildenafil treatment in AMD patients will be compared with age-matched control subjects using standard statistical methods. By also correlating choroidal thickness changes with functional (visual acuity) and anatomical (CMT & MV) changes, the investigators hope to further their understanding of the choroid's role in aging and AMD pathogenesis. The safety of a single dose of sildenafil citrate will be addressed by excluding any patients with risk factors or using medications that are contraindicated for sildenafil as determined by careful informed consent and a study questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •has been diagnosed with AMD (362.50-52) or healthy controls as detailed above
- •at least 65 years of age
- •capable and willing to provide consent
排除标准
- •History of previous photodynamic therapy (PDT), intravitreal corticosteroid injection, macular focal laser photocoagulation, panretinal photocoagulation, ocular ionizing irradiation, transpupillary thermotherapy, or any vitreoretinal surgeries
- •History of central serous chorioretinopathy, polypoidal choroidal vasculopathy, uveitis, or diabetic retinopathy
- •History of amblyopia, glaucoma, retinal detachment, retinal dystrophy, ocular trauma, ocular tumor, proliferative retinopathy, or epiretinal membrane with distortion of central macula
- •History of myopia of more than 6 diopters (D) spherical equivalent
- •History of uncontrolled diabetes or hypertension
- •Current use of oral phosphodiesterase type 5 inhibitors (including sildenafil, avanafil, lodenafil, mirodenafil, tadalafil, vardenafil, udenafil, zaprinast)
- •Current use of systemic corticosteroids
- •Any contraindication to sildenafil use, including history of cardiovascular disease or stroke, hepatic cirrhosis (Child-Pugh A and B), severe renal impairment (creatinine clearance <30mL/min), anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease), disorders predisposing to priapism (e.g. sickle cell anemia, multiple myeloma, or leukemia), or current use of organic nitrates, alpha-blockers, or potent cytochrome P450 3A4 inhibitors
研究组 & 干预措施
Healthy Controls
Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
干预措施: Sildenafil citrate (Drug)
AMD patients
Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness
干预措施: Sildenafil citrate (Drug)
结局指标
主要结局
Change in Choroidal Thickness as Assessed on Enhanced-Depth Imaging Optical Coherence Tomography (EDI-OCT)
时间窗: Baseline, 1 hour, and 3 hours post-treatment
次要结局
- Change in Central Foveal Thickness as Assessed by Optical Coherence Tomography (OCT)(Baseline, 1hour, and 3 hours post-treatment)