Cholesterol Efflux Capacity and Potential Serum Biomarkers in Macular Degeneration and Diabetic Retinopathy

Study ID
STU 102015-017

Cancer Related

Healthy Volunteers

Study Sites

  • UT Southwestern Ambulatory Services

Lisa Davis

Principal Investigator
Anna Kupcha


The study design will be a case-control series of between 20 and 60 patients with dry age related macular degeneration, between 20 and 60 patients with wet macular degeneration, between 20 and 60 patients with diabetic retinopathy, and between 20 and 80 age matched controls. The primary clinical information will be from patients seen at aston ambulatory Care Center (aaCC) Clinic. The study period will be from 1/1/2016 to 1/1/2019. Potentially eligible patients will be approached and queried for study participation; those who agree and sign the informed consent will either be asked, or their medical records will be reviewed, for the following : age, date of diagnosis w/ aMD and/or w/DR, most recent fundoscopic exam findings, whether or not they are currently or were previously on a Statin medication, niacin or other lipid / cholesterol medication, or ophthalmic medication, visual acuity, and recent serum lipid (LDL, HDL, total cholesterol) levels. Participants meeting all inclusion/exclusion criteria will undergo a single peripheral blood draw (approximately 5 mls or 1 teaspoon) that is performed solely for the purposed of this research. These procedures will normally take place in a single visit expected to last 1 to 1 [1/2]) hours. owing to time constraints, in some instances it may be necessary for the single peripheral blood draw to be performed during a second visit. Serum will be isolated and samples used for cholesterol efflux measurements according to the methods described by Rohatgi et al (see below). We will also use them to look at other potential biomarkers including Rna, proteins and lipids. For example, microRnas have been found to be useful biomarkers of metabolic abnormalities. Medical records for the participants will be reviewed up to twice a year after initial enrollment to assess disease development or progression. The study will last approximately 3 years.

We will also obtain de-identified plasma samples and data which will include aMD status, diabetes status, history of cardiovascular disease, smoking status, age, gender, and race/ethnicity that were all collected as part of another study. of the de-identified samples and data we aim to obtain 200 aMD cases and 200 controls.

Participant Eligibility

Subjects will be recruited from Aston Ambulatory Care Center. Patients will be 50 years or older in age and have a diagnosis of age related macular degeneration or diabetic retinopathy based on clinical exam, the severity / subtype of disease will be noted for analysis of results, but all patients with the diagnosis will be included for evaluation. Controls will be greater than 50 years of age, without significant clinical evidence of age related macular degeneration or diabetic retinopathy on recent (within 1 year) fundoscopic exam.