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Age-related Macular Degeneration (AMD) and Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT04087356
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
The New York Eye & Ear Infirmary

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.

Condition or disease Intervention/treatment
Age-related Macular Degeneration Coronary Artery Disease Cardiovascular Diseases Genetic: Blood draw

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Age-related Macular Degeneration (AMD) and Cardiovascular Disease
Actual Study Start Date : August 2, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RMD+ Patients
Age-related macular degeneration patients with reticular macular disease
Genetic: Blood draw
Blood samples are collected for genetic analysis, looking specifically at serum lipids and the inflammatory biomarker hs-CRP.

RMD- Patients
Age-related macular degeneration patients without reticular macular disease
Genetic: Blood draw
Blood samples are collected for genetic analysis, looking specifically at serum lipids and the inflammatory biomarker hs-CRP.




Primary Outcome Measures :
  1. Proportion of CAD+ patients in RMD+ Patients [ Time Frame: 6 months ]
    Rate of coronary artery disease in age-related macular disease patients with reticular macular disease

  2. Proportion of CAD+ patients in RMD- Patients [ Time Frame: 6 months ]
    Rate of coronary artery disease in age-related macular disease patients without reticular macular disease


Secondary Outcome Measures :
  1. Evaluation of CAD risk factors as predictors of RMD status [ Time Frame: 6 months ]
    Investigating the relationship between AMD/RMD to cardiac risk factors such as tobacco use, hyperlipidemia, elevated C-Reactive protein an inflammatory biomarker, and hypertension.

  2. Correlation of lipid panels with RMD status [ Time Frame: 6 months ]
    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.

  3. Correlation of the C-Reactive Protein as an inflammatory biomarker with RMD status [ Time Frame: 6 months ]
    High sensitivity CRP (hsCRP) blood tests able to measure down to 0.3 mg/L which is necessary in risk assessment for vascular disease.

  4. Correlation of imaging features with RMD status [ Time Frame: 6 months ]
    Correlation of presence of soft drusen, geographic atrophy or choroidal neovascularization status in fellow eye, if present, with RMD status

  5. 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. [ Time Frame: 6 months ]
    High sensitivity RMD genetic blood test for markers with RMD status


Biospecimen Retention:   Samples With DNA
Blood draw for serum markers and genetics


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with AMD with and without RMD
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04087356


Contacts
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Contact: R. Theodore Smith, MD PhD 212-9794579 rolandtheodore.smith@mssm.edu
Contact: Katy Tai 212-979-4251 ktai@nyee.edu

Locations
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United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Theodore Smith, MD    212-979-4579    rolandtheodore.smith@mssm.edu   
Principal Investigator: Theodore Smith, MD         
Sub-Investigator: Bailey Freund, MD         
Sponsors and Collaborators
The New York Eye & Ear Infirmary
Investigators
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Study Chair: R. Theodore Smith, MD PhD New York Eye And Ear Infirmary of Mount Sinai

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Responsible Party: The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier: NCT04087356     History of Changes
Other Study ID Numbers: IRB-19-01872
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Coronary Artery Disease
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Retinal Degeneration
Retinal Diseases
Eye Diseases