Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04087356
Status:
UNKNOWN
Last Update Posted:
2019-09-12
First Post:
2019-07-09
Brief Title:
Age-related Macular Degeneration AMD and Cardiovascular Disease
Sponsor:
The New York Eye Ear Infirmary
Organization:
The New York Eye Ear Infirmary
Study Overview
Official Title:
Age-related Macular Degeneration AMD and Cardiovascular Disease
Status:
UNKNOWN
Status Verified Date:
2019-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to investigate the link between age-related macular degeneration AMD or ARMD and coronary artery disease CAD Age-related macular degeneration is a medical condition which may result in blurred or no vision in the center of vision Coronary artery disease is a blockage of one or more arteries that supply blood to the heart The study will specifically look at the macular changes that occur in the retina which is the sensory membrane that lines the inner surface at the back of the eyeball and the relationship between coronary heart disease and the risk factors
Detailed Description:
The treatment of age-related macular degeneration AMD the leading cause of blindness in the developed world is undergoing a revolution Intraocular injections of medications that can shut down the rapidly destructive wet form of the disease have changed this form to a chronic illness However vision is still lost For the early forms of AMD progression to the advanced wet and dry forms and severe vision loss is impeded but not stopped by current therapies of oral antioxidants Thus a better understanding of early AMD is needed to discover its root causes and provide treatment before irreparable damage is done
The most important highest-risk and least understood form of early AMD is reticular macular disease RMD RMD is associated with significant progression to advanced AMD both wet and dry The lesions of RMD are well seen on the advanced retinal imaging techniques of spectral domain optical coherence tomography SD-OCT and scanning laser ophthalmoscopy SLO On SLO RMD presents a pox-like pattern of dark defects SD-OCT provides high-resolution cross-sectional images of the retina where RMD is seen as a collection of cholesterol-containing deposits and the choroid an essential blood supply of the retina which is thinned and may be damaged in RMD A unified explanation of these facets of RMD is lacking
Regarding AMD and systemic diseases the association between stroke heart attack and AMD has been studied but with some conflicting findings For example a relationship with heart attack has been established in patients less than age 75 but not in older patients Where does RMD fit in At present no one knows However the known facts are these RMD is associated with decreased longevity which is not the case with other early forms of AMD This could happen if RMD and systemic vascular disease co-exist Finally there is the very high proportion of women relative to men among older patients with RMD about 85 Women develop heart disease later than men and survive heart disease a decade longer on average It is possible that these diseases both begin earlier in life with more men dying before reaching older ages and demonstrating RMD The research team submitting this proposal has preliminary data suggesting that this is in fact the case
In a small group of subjects 50-75 years old RMD was detected in a significant proportion of those with CAD compared to those without Furthermore in this younger group the ratio of men to women in the RMD group was equal The team proposes a large-scale initiative to provide definitive answers to these questions in collaboration with expert cardiologists and neurologists to document vascular status unequivocally and utilizing the most advanced retinal imaging available for the detection of RMD This could lead to greater understanding of all three stroke heart attack and AMD and ultimately better treatment providing much needed relief to suffering patients and relief to the healthcare burden of an aging population
The most important highest-risk and least understood form of early AMD is reticular macular disease RMD RMD is associated with significant progression to advanced AMD both wet and dry The lesions of RMD are well seen on the advanced retinal imaging techniques of spectral domain optical coherence tomography SD-OCT and scanning laser ophthalmoscopy SLO On SLO RMD presents a pox-like pattern of dark defects SD-OCT provides high-resolution cross-sectional images of the retina where RMD is seen as a collection of cholesterol-containing deposits and the choroid an essential blood supply of the retina which is thinned and may be damaged in RMD A unified explanation of these facets of RMD is lacking
Regarding AMD and systemic diseases the association between stroke heart attack and AMD has been studied but with some conflicting findings For example a relationship with heart attack has been established in patients less than age 75 but not in older patients Where does RMD fit in At present no one knows However the known facts are these RMD is associated with decreased longevity which is not the case with other early forms of AMD This could happen if RMD and systemic vascular disease co-exist Finally there is the very high proportion of women relative to men among older patients with RMD about 85 Women develop heart disease later than men and survive heart disease a decade longer on average It is possible that these diseases both begin earlier in life with more men dying before reaching older ages and demonstrating RMD The research team submitting this proposal has preliminary data suggesting that this is in fact the case
In a small group of subjects 50-75 years old RMD was detected in a significant proportion of those with CAD compared to those without Furthermore in this younger group the ratio of men to women in the RMD group was equal The team proposes a large-scale initiative to provide definitive answers to these questions in collaboration with expert cardiologists and neurologists to document vascular status unequivocally and utilizing the most advanced retinal imaging available for the detection of RMD This could lead to greater understanding of all three stroke heart attack and AMD and ultimately better treatment providing much needed relief to suffering patients and relief to the healthcare burden of an aging population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None