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Age-related Macular Degeneration | Effects of Sildenafil on Choroidal Thickness in AMD

Age-related Macular Degeneration research study

What is the primary objective of this study?

Who is eligible to participate?

Inclusion Criteria: - 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 Criteria: - 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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Age-related Macular Degeneration

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sildenafil citrateSingle dose of 100mg Sildenafil citrate

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Healthy ControlsHealthy 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

AMD patientsAge-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

Study Status

Terminated

Start Date: March 2013

Completed Date: May 2014

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Change in Choroidal Thickness as Assessed on Enhanced-Depth Imaging Optical Coherence Tomography (EDI-OCT)

Secondary Outcome: Change in Central Foveal Thickness as Assessed by Optical Coherence Tomography (OCT)

Study sponsors, principal investigator, and references

Principal Investigator: Sharon Fekrat, MD

Lead Sponsor: Duke University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01830790

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