Status:
TERMINATED
Effects of Sildenafil on Choroidal Thickness in AMD
Lead Sponsor:
Duke University
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
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 disea...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01830790
Start Date
March 1 2013
End Date
May 1 2014
Last Update
June 23 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke Eye Center
Durham, North Carolina, United States, 27710