sildenafil-citrate and Macular-Degeneration

The aim of the present study was to investigate the effect of sildenafil citrate (viagra) on retinal venous diameter in patients with age-related macular degeneration (AMD). We investigated 14 male patients in a double-masked, randomized, placebo-controlled, crossover study. In each subject, one eye with typical non-exudative AMD fundus features was studied. Each of the subjects received 100 mg dose of sildenafil or matching placebo on two separate study visits. Monochromatic fundus photographs were obtained in the study eye before dosing and then 30, 90, 180 and 300 min later. Measurements of the diameter of the major retinal veins from digitized negatives were carried out using "Vessel map" static vessel analysis program (IMEDOS GmbH, Weimar, Germany). Statistical analysis of the data comparing the effect of sildenafil and placebo on venous diameters was performed using analysis of variance (ANOVA) for repeated measures. An analysis of variance (ANOVA) comparing the effects of sildenafil citrate and placebo on retinal vein diameters showed a significant interaction between time and treatment (P = 0.03). In comparison to placebo, sildenafil citrate produced a statistically significant vasodilatation of major retinal veins of 4.7% at 90 min (P = 0.004), 5.5% at 180 min (P < 0.0001) and 5.8% at 300 min (P < 0.0001). At 30 min there was a 2.2% difference, which was not statistically significant (P=0.14). Our results suggest that in patients with age-related macular degeneration, sildenafil citrate (viagra) produces a statistically significant vasodilatation of major retinal veins that is similar to what has been reported in normal subjects. Whether this vasodilatation is associated with changes in retinal blood flow needs to be further investigated.

Topics: Administration, Oral; Aged; Cross-Over Studies; Double-Blind Method; Fluorescein Angiography; Humans; Macular Degeneration; Male; Piperazines; Purines; Retinal Vein; Sildenafil Citrate; Sulfones; Treatment Outcome; Vasodilation; Vasodilator Agents

To investigate the effects of sildenafil citrate (Viagra) on foveolar choroidal circulation in patients with age related macular degeneration (AMD). Double-blinded, randomized, placebo-controlled, crossover study. Fifteen male AMD patients received a dose of 100 mg of sildenafil or matching placebo on two separate days. Laser Doppler flowmetry was performed to assess relative choroidal blood velocity (ChB(Vel)), volume (ChB(Vol)) and flow (ChB(Flow)) in the study eye prior to administration of the drug at baseline and 30, 90, 180, 300 min after dosing. Best corrected visual acuity (BCVA), contrast sensitivity (CS), mean arterial blood pressure (BPm), heart rate (HR), intraocular pressure (IOP) and ocular perfusion pressure (PP) were determined. In comparison to placebo, sildenafil did not cause any statistically significant changes in mean ChB(Vel) (ANOVA, P=0.12), ChB(Vol) (ANOVA, P=0.24) or ChB(Flow) (ANOVA, P=0.46). There were no statistically significant changes in CS (ANOVA, P=0.59), BCVA (P=0.58), IOP (P=0.81) or HR (P=0.07) throughout the study. Significant decreases in BPm (P=0.006) and PP (P=0.006) were observed at 30 min after sildenafil. Administration of sildenafil citrate didn't cause any statistically significant changes in the foveolar choroidal circulation of AMD patients.

Topics: Aged; Blood Flow Velocity; Blood Pressure; Choroid; Contrast Sensitivity; Double-Blind Method; Fovea Centralis; Heart Rate; Humans; Intraocular Pressure; Laser-Doppler Flowmetry; Macular Degeneration; Male; Piperazines; Purines; Regional Blood Flow; Sildenafil Citrate; Sulfones; Vasodilator Agents; Visual Acuity

To assess the effects of a single 100-mg dose of sildenafil citrate on visual function in men with early-stage age-related macular degeneration.. Randomized double-blind placebo-controlled clinical trial.. Nine men (mean age 71 years, range 59-85 years) with early-stage (minimal visual impairment and large drusen in the macula) age-related macular degeneration and 20/40 or better-corrected visual acuity in at least one eye were prospectively randomized to receive either placebo or sildenafil citrate (Viagra; Pfizer Inc, New York, New York) 100 mg as a single oral dose. After 7-14 days, they received the alternate treatment. Subjects underwent visual acuity, Amsler grid, color discrimination (D15), traffic light, Humphrey perimetry, and photo-stress testing in each eye before and at specific intervals within 8 hours after dosing.. Compared with placebo, no pattern of errors were evident in any visual function test following sildenafil administration. No statistically or clinically relevant changes from baseline were observed in visual acuity, Humphrey perimetry (corrected pattern standard deviation), D15 color discrimination, or photo-stress tests. No clinically relevant changes were observed in the Amsler grid or traffic light tests. Sildenafil treatment was associated with transient mild or moderate headache, flushing, and rhinitis. There were no visual adverse events spontaneously reported to the investigator.. A single 100-mg dose of sildenafil was well tolerated and produced no acute visual effects or exacerbation of preexisting visual impairment in nine men with early-stage age-related macular degeneration.

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Aged; Aged, 80 and over; Color Perception; Color Perception Tests; Cross-Over Studies; Double-Blind Method; Drug Evaluation; Humans; Macular Degeneration; Male; Middle Aged; Phosphodiesterase Inhibitors; Piperazines; Prospective Studies; Purines; Safety; Sildenafil Citrate; Sulfones; Visual Acuity; Visual Field Tests; Visual Fields

Age-related macular degeneration (AMD) - the leading cause of vision loss in the elderly - share many risks factors as atherosclerosis, which exhibits loss of vascular compliance resulting from aging and oxidative stress. Here, we attempt to explore choroidal and retinal vascular compliance in patients with AMD by evaluating dynamic vascular changes using live ocular imaging following treatment with oral sildenafil citrate, a phosphodiesterase type 5 (PDE5) inhibitor and potent vasodilator. Enhanced-depth imaging optical coherence tomography (EDI-OCT) and OCT angiography (OCT-A) were performed on 46 eyes of 23 subjects, including 15 patients with non-exudative AMD in one eye and exudative AMD in the fellow eye, and 8 age-matched control subjects. Choroidal thickness, choroidal vascularity, and retinal vessel density were measured across the central macula at 1 and 3 hours after a 100 mg oral dose of sildenafil citrate. Baseline choroidal thickness was 172.1 ± 60.0 μm in non-exudative AMD eyes, 196.4 ± 89.8 μm in exudative AMD eyes, and 207.4 ± 77.7 μm in control eyes, with no difference between the 3 groups (P = 0.116). After sildenafil, choroidal thickness increased by 6.0% to 9.0% at 1 and 3 hours in all groups (P = 0.001-0.014). Eyes from older subjects were associated with choroidal thinning at baseline (P = 0.005) and showed less choroidal expansion at 1 hour and 3 hours after sildenafil (P = 0.001) regardless of AMD status (P = 0.666). The choroidal thickening appeared to be primarily attributed to expansion of the stroma rather than luminal component. Retinal vascular density remained unchanged after sildenafil in all 3 groups (P = 0.281-0.587). Together, our studies suggest that vascular response of the choroid to sildenafil decreases with age, but is not affected by the presence of non-exudative or exudative AMD, providing insight into changes in vessel compliance in aging and AMD.

Topics: Aged; Aged, 80 and over; Aging; Case-Control Studies; Choroid; Female; Fluorescein Angiography; Humans; Macula Lutea; Macular Degeneration; Male; Phosphodiesterase 5 Inhibitors; Retinal Vessels; Sildenafil Citrate; Tomography, Optical Coherence; Vasodilator Agents

A patient-reported outcome is any report on the status of a patient's health condition that comes directly from the patient. Clear and meaningful interpretation of patient-reported outcome scores are fundamental to their use as they can be valuable in designing studies, evaluating interventions, educating consumers, and informing health policy makers involved with regulatory, reimbursement, and advisory agencies. Interpretation of patient-reported outcome scores, however, is often not well understood because of insufficient data or lack of experience or clinical understanding to draw from. This article provides an update review on two broad approaches--anchor-based and distributed-based--aimed at enhancing the understanding and meaning of patient-reported outcome scores. Anchor-based approaches include percentages based on thresholds, criterion-group interpretation, content-based interpretation, and clinical important difference. Distributed-based approaches include effect size, probability of relative benefit, and responder analysis and cumulative proportions. A third strategy called mediation analysis, which can elucidate a health condition measured by a patient-reported outcome in the context of an intervention's mechanism of action, is also highlighted and illustrated. Mediation analysis in the context of interpretation of patient-reported outcome scores is a relatively new development. The logic and rationale of the three methods are expressed generally. While the three approaches themselves are not new, some applications of them taken from their examples published in the past few years are original and coalesced in this article to add real-life implications of the different methodologies in one integrated report.

Topics: Analgesics; Clinical Trials as Topic; Data Interpretation, Statistical; Erectile Dysfunction; Female; Fibromyalgia; gamma-Aminobutyric Acid; Humans; Macular Degeneration; Male; Patient Outcome Assessment; Piperazines; Pregabalin; Purines; Sickness Impact Profile; Sildenafil Citrate; Sulfonamides; Surveys and Questionnaires; Urological Agents

Topics: 3',5'-Cyclic-GMP Phosphodiesterases; Contraindications; Humans; Macular Degeneration; Male; Phosphodiesterase Inhibitors; Piperazines; Purines; Sildenafil Citrate; Sulfones