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Age-Related Macular Degeneration clinical trials

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NCT ID: NCT01830790 Terminated - Clinical trials for Age-related Macular Degeneration

Effects of Sildenafil on Choroidal Thickness in AMD

Start date: March 2013
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT01717937 Terminated - Clinical trials for Diabetic Retinopathy

Comparison of Phase-variance Optical Coherence Tomography and Fluorescein Angiography in Retinovascular Imaging

PVOCT
Start date: February 2013
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether phase variance optical coherence tomography (PV-OCT), a software-based optical coherence tomography(OCT) image processing technology, can be used to generate angiographic images of the retinochoroidal vasculature that are comparable to those produced by fluorescein angiography (FA), the current gold standard diagnostic test.

NCT ID: NCT01402544 Terminated - Clinical trials for Age-Related Macular Degeneration

Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab

COMPASS
Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA.

NCT ID: NCT01337414 Terminated - Clinical trials for Age-related Macular Degeneration

Tools to Optimize Patient Presentation After Onset of Exudative Age-Related Macular Degeneration (AMD)

Start date: May 1, 2010
Phase: N/A
Study type: Interventional

Exudative age-related macular degeneration ("wet" AMD) continues to be a leading cause of central vision loss in the US for those over fifty years of age, despite the availability of several effective interventions to contain damaging neovascularization (new, abnormal blood vessel growth). The effectiveness of treatments is challenged by patients' lack of ability to recognize the need for urgent care between regular office visits. The Amsler and Yanuzzi tests, the only widely used self-tests for AMD, have proven largely ineffective at enabling patients to recognize the signs that they should consult their retina specialist for treatment. For optimal benefit, patients should be able to self-monitor their vision over time and detect changes that may be indicative of an exudative event. To facilitate compliance these observations should be part of a larger and more engaging program of AMD awareness and self-monitoring. Among the principal shortcomings of the current "gold-standard" Amsler grid are periodicity of the test pattern and lack of individual adjustment, and therefore the reliability and accuracy of this test are less than optimal for the detection of exudative retinal changes in AMD patients. In phase I of the current study, the investigatorsW developed and evaluated several versions of improved grids, both on paper and on the Internet. These patent-pending Visual and Memory Stimulating (VMS) grids proved at least equivalent to the Amsler grid in facilitating a substantial degree of recall of prior measurements, necessary for monitoring vision over time. Adjustment features were incorporated in the on-line version to allow patients to customize their grid to their particular visual field. In the phase II study the use of VMS grids will be supplemented by a test booklet that contains educational materials and diary based survey questions in addition to the printed VMS grids; the effectiveness of this booklet for self-monitoring will be compared the standard of care (Amsler grid). Goal of the study is to demonstrate that use of the test booklet leads to more rapid identification of newly developing vision problems, earlier diagnosis and treatment of incipient wet AMD that should result in fewer people losing their vision and less severe losses of vision.

NCT ID: NCT01319188 Terminated - Clinical trials for Coronary Artery Disease

Ranibizumab and the Risk of Arterial Thromboembolic Events

RATE
Start date: June 2010
Phase: Phase 4
Study type: Interventional

The investigators assume that ranibizumab might be dangerous in patients with history of coronary artery disease or cerebrovascular events. The main objective of study is to reveal contraindications for ranibizumab prescription in patients with history of coronary artery disease and cerebrovascular events. Moreover, an association between management with ranibizumab and ATE rate in healthy above 50 years old persons is a concern of great interest as well.

NCT ID: NCT01025232 Terminated - Clinical trials for Macular Degeneration

A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)

SAVE
Start date: December 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.

NCT ID: NCT00993330 Terminated - Clinical trials for Age Related Macular Degeneration

Macular Pigment Optical Density in Healthy Subjects

Start date: May 2009
Phase: N/A
Study type: Observational

The macular pigment (MP) in humans consists of the yellow, blue-absorbing carotenoids lutein and zeaxanthin, which are contained in vegetables and fruits. The highest concentrations of lutein and zeaxanthin are found in the fovea. Since light entering the eye passes through the MP before reaching the photo receptors it absorbs a significant portion of short-wavelength light. There is evidence that these absorbing properties of the MP as well as the ability of inactivating highly reactive oxygen species are protective for the retina. Measurement of macular pigment is difficult and the investigators have recently proposed a way of measuring macular pigment optical density (MPOD) based on optical reflectometry. There is increased interest in these measurements in the recent years, because a number of studies has provided evidence that low fruit and vegetable consumption increases the risk of age related macular degeneration (AMD). The present study investigates MP optical density (OD) in healthy volunteers and is used to form a database. Furthermore the nutritional habits and the influence on MP density will be evaluated.

NCT ID: NCT00987129 Terminated - Clinical trials for Age-related Macular Degeneration

Omega 6:Omega 3 Ratio and Progression of Age-related Macular Degeneration (AMD).

Start date: March 2012
Phase: Phase 3
Study type: Observational

Docosahexaenoic acid (DHA) supplementation has been shown to prevent specific age-related changes in the retina through biochemical and functional evaluations, but it is unclear whether increased DHA intake-reflected through elevated DHA+EPA blood levels-can affect the natural history and progression of age-related macular degeneration (AMD). AMD is a disease affecting the macula, the part of the eye containing cone photoreceptors at the center of the visual field. The macula is responsible for vision in most daily functions, including reading, seeing fine details, and colour recognition. Severe AMD can lead to a central scotoma, severely impairing daily functioning. AMD can be divided into two forms: the more severe wet AMD, consisting of proliferation of new blood vessels in the retina, and dry AMD characterized by the development of drusen, a buildup of extracellular material . The investigators are focused on the group with the highest risk of developing the two advanced forms of AMD [wet AMD or central geographic atrophy]: patients with unilateral wet AMD and dry AMD in their other eye. The study will consist of following up a cohort of such subjects and monitoring their visual function in a comprehensive manner. Working in concert with clinical ophthalmologists and basic scientists, the investigators will monitor "DHA+EPA" and "Omega6:Omega3 fatty acid ratio" levels in the blood, inherited predispositions through genetic analysis, lipofuscin (an accumulated waste product) levels & AMD progression via fundus photography, visual acuity, and retinal function via full-field and multifocal electroretinograms. These different factors will be cross-correlated and evaluated to determine how omega-3 fatty acids affect the progression of AMD.

NCT ID: NCT00890097 Terminated - Clinical trials for Age-Related Macular Degeneration

Geographic Atrophy Treatment Evaluation

GATE
Start date: April 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the safety and efficacy of AL-8309B Ophthalmic Solution versus Vehicle administered as a topical ocular drop for the treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

NCT ID: NCT00857259 Terminated - Clinical trials for Age-related Macular Degeneration

The Efficacy of Oral Everolimus in Patients With Neovascular Age-related Macular Degeneration

Start date: February 2009
Phase: Phase 2
Study type: Interventional

The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD)