Age-related Macular Degeneration (AMD) and Cardiovascular Disease
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedStudy Start
First participant enrolled
August 2, 2019
CompletedFirst Posted
Study publicly available on registry
September 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2020
CompletedSeptember 12, 2019
September 1, 2019
6 months
July 9, 2019
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of CAD+ patients in RMD+ Patients
Rate of coronary artery disease in age-related macular disease patients with reticular macular disease
6 months
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 Outcomes (5)
Evaluation of CAD risk factors as predictors of RMD status
6 months
Correlation of lipid panels with RMD status
6 months
Correlation of the C-Reactive Protein as an inflammatory biomarker with RMD status
6 months
Correlation of imaging features with RMD status
6 months
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.
6 months
Study Arms (2)
RMD+ Patients
Age-related macular degeneration patients with reticular macular disease
RMD- Patients
Age-related macular degeneration patients without reticular macular disease
Interventions
Blood samples are collected for genetic analysis, looking specifically at serum lipids and the inflammatory biomarker hs-CRP.
Eligibility Criteria
Patients with AMD with and without RMD
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Related Publications (1)
Thomson RJ, Chazaro J, Otero-Marquez O, Ledesma-Gil G, Tong Y, Coughlin AC, Teibel ZR, Alauddin S, Tai K, Lloyd H, Scolaro M, Govindaiah A, Bhuiyan A, Dhamoon MS, Deobhakta A, Narula J, Rosen RB, Yannuzzi LA, Freund KB, Smith RT. SUBRETINAL DRUSENOID DEPOSITS AND SOFT DRUSEN: Are They Markers for Distinct Retinal Diseases? Retina. 2022 Jul 1;42(7):1311-1318. doi: 10.1097/IAE.0000000000003460.
PMID: 35213528DERIVED
Biospecimen
Blood draw for serum markers and genetics
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
R. Theodore Smith, MD PhD
New York Eye And Ear Infirmary of Mount Sinai
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2019
First Posted
September 12, 2019
Study Start
August 2, 2019
Primary Completion
January 31, 2020
Study Completion
December 20, 2020
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share