Effects of Sildenafil on Choroidal Thickness in AMD

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Sleutelwoorden

Abstract

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.

Datums

Laatst geverifieerd:	03/31/2015
Eerste ingediend:	04/09/2013
Geschatte inschrijving ingediend:	04/10/2013
Eerst geplaatst:	04/11/2013
Laatste update ingediend:	05/26/2015
Laatste update geplaatst:	06/22/2015
Datum van eerste ingediende resultaten:	04/28/2015
Datum van eerste ingediende QC-resultaten:	04/28/2015
Datum van eerste geposte resultaten:	05/13/2015
Werkelijke startdatum van het onderzoek:	02/28/2013
Geschatte primaire voltooiingsdatum:	04/30/2014
Geschatte voltooiingsdatum van het onderzoek:	04/30/2014

Conditie of ziekte

Age-related Macular Degeneration

Interventie / behandeling

Drug: Sildenafil citrate

Fase

Fase 2

Armgroepen

Arm	Interventie / behandeling
Active Comparator: 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
Experimental: 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

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie	65 Years Naar 65 Years
Geslachten die in aanmerking komen voor studie	All
Accepteert gezonde vrijwilligers	Ja
Criteria	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

Resultaat

Primaire uitkomstmaten

1. Change in Choroidal Thickness as Assessed on Enhanced-Depth Imaging Optical Coherence Tomography (EDI-OCT) [Baseline, 1 hour, and 3 hours post-treatment]

Secundaire uitkomstmaten

1. Change in Central Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) [Baseline, 1hour, and 3 hours post-treatment]

Effects of Sildenafil on Choroidal Thickness in AMD

Sleutelwoorden

phosphodiesterase

atrofie

macular degeneration

citrate