Age-related Macular Degeneration (AMD) and Cardiovascular Disease

Coronary Artery Disease Clinical Trial

Official title:

Age-related Macular Degeneration (AMD) and Cardiovascular Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04087356
• Other study ID #: IRB-19-01872
• Status: Recruiting
• Start date: August 2, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: September 2019
• Source: The New York Eye & Ear Infirmary
• Contact: R. Theodore Smith, MD PhD
• Phone: 212-9794579
• Email: rolandtheodore.smith[@]mssm.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 20, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of age-related macular degeneration in at least one eye.

• Patients can have unilateral, but not bilateral CNV. In the case of unilateral CNV, the eye without the CNV will be the study eye.

• Age greater than 50

• Willing and able to comply with clinic visit and study-related procedures

• Provide signed informed consent

• Able to understand and complete study-related questionnaire

• Be able to tolerate dilating drops

Exclusion Criteria:

• Bilateral CNV

• Other retinal degenerations and retinal vascular diseases such as diabetic retinopathy or macular edema, prior retinal surgery

• Pregnant, lactating, or currently expecting a child

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Cardiovascular Diseases
• Coronary Artery Disease
• Macular Degeneration

Intervention

Genetic:
• Blood draw
Blood samples are collected for genetic analysis, looking specifically at serum lipids and the inflammatory biomarker hs-CRP.

Locations

Country	Name	City	State
United States	New York Eye and Ear Infirmary	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
The New York Eye & Ear Infirmary

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of CAD+ patients in RMD+ Patients	Rate of coronary artery disease in age-related macular disease patients with reticular macular disease	6 months
Primary	Proportion of CAD+ patients in RMD- Patients	Rate of coronary artery disease in age-related macular disease patients without reticular macular disease	6 months
Secondary	Evaluation of CAD risk factors as predictors of RMD status	Investigating the relationship between AMD/RMD to cardiac risk factors such as tobacco use, hyperlipidemia, elevated C-Reactive protein an inflammatory biomarker, and hypertension.	6 months
Secondary	Correlation of lipid panels with RMD status	Measuring the total cholesterol in blood, the standard cholesterol test (called a "lipid panel") measures three specific kinds of fat: Low-density lipoproteins (LDL). High-density lipoproteins (HDL). Triglycerides.	6 months
Secondary	Correlation of the C-Reactive Protein as an inflammatory biomarker with RMD status	High sensitivity CRP (hsCRP) blood tests able to measure down to 0.3 mg/L which is necessary in risk assessment for vascular disease.	6 months
Secondary	Correlation of imaging features with RMD status	Correlation of presence of soft drusen, geographic atrophy or choroidal neovascularization status in fellow eye, if present, with RMD status	6 months
Secondary	Correlation of genetic markers with CFHY402H and CFHrs1410996 genotypes, adjusting for AMD grade. These phenotypes may be a marker of genetic susceptibility for patients with RMD status.	High sensitivity RMD genetic blood test for markers with RMD status	6 months