Recruiting

Observational Study

Sponsor:

The New York Eye & Ear Infirmary

Code:

NCT04087356

Conditions

Age-related Macular Degeneration

Coronary Artery Disease

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Blood draw

Study Details

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.

Conditions

Age-related Macular Degeneration

Coronary Artery Disease

Cardiovascular Diseases

Study ID

NCT04087356

Start date

Aug 2, 2019

Status verified date

Sep, 2019

Completion date

Dec 20, 2020

Anticipated

Primary completion date

Jan 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

RMD+ Patients

Age-related macular degeneration patients with reticular macular disease

RMD- Patients

Age-related macular degeneration patients without reticular macular disease

Interventions

Blood draw

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

Primary outcome measure

  • Proportion of CAD+ patients in RMD+ Patients [ Time Frame: 6 months ]
  • Proportion of CAD+ patients in RMD- Patients [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

R. Theodore Smith, MD PhD

212-9794579rolandtheodore.smith@mssm.edu

Katy Tai

212-979-4251ktai@nyee.edu

Locations

New York Eye and Ear Infirmary

Recruiting

New York, New York, United States, 10003

Contacts

Theodore Smith, MD

212-979-4579rolandtheodore.smith@mssm.edu

Principal Investigator:

Theodore Smith, MD

More Information

Sponsor

The New York Eye & Ear Infirmary

Last update posted

Sep 12, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The New York Eye & Ear Infirmary on 2019-09-12.