Patients can be any race and must be between the ages of 50 and 85 years inclusive.
Patients must weigh ≥110 lb (50 kg).
Study eye must have a diagnosis of nonexudative “dry” AMD with ≥10 large, soft, semisoft, and/or confluent drusen within 3,000 nm of the foveal center.
Study eye must have a best-corrected visual acuity using the ETDRS chart between 20/32 and 20/125 inclusive.
Geographic atrophy is allowed as long as it is less than three disc diameters outside of 3,000 nm of the foveal center.
Serous pigment epithelial detachment is allowed as long as no clearly identifiable neovascularization is present.
Patients must have elevated baseline concentrations of two of the following three rheologic factors: total serum cholesterol level ≥200 mg/dL, fibrinogen level ≥300 mg/dL, or serum immunoglobulin A (IgA) level ≥200 mg/dL, as determined at the qualifying evaluation.
Patients must have a score of no more than 75 on the VFQ-25 Visual Functioning Questionnaire.
Study eye must not have conditions that limit the view of the fundus.
Patients must have normal prothrombin and partial thromboplastin clotting times with the exception of patients who are stable on long-term Coumadin therapy.
Patients must have adequate bilateral antecubital venous access.
Patients taking lipid-lowering medication at the beginning of the treatment phase must agree to continue to take it throughout the treatment phase using their current regimen.
Patients must be available for minimum study duration of about 12 months.
Patients must be highly motivated, alert, oriented, mentally competent, and able to understand and comply with the requirements of the study.
Patients must agree to discontinue their previous vitamin regimen and to substitute their regimen with a uniform supplement regimen provided by the study, OcularRx (Science-Based Health, Corde Madera, California). This was done to ensure that every patient in the study ingested the same supplement regimen.
