Why is this research being done?
The purpose of this study is to assess the safety and effectiveness of the investigational drug ORACEA ® to determine if it can slow the progression of geographic atrophy in participants who have geographic atrophy secondary to non-exudative age-related macular degeneration (dry AMD).
Dry AMD affects the macula. The macula is the center of the retina (the light sensitive tissue at the back of they eye) and is the part of the eye that is used to see fine details needed to perform many everyday tasks. As we age, the cells in the macula may start to break down or degenerate, causing a decrease in the central vision that is needed for daily activities such as recognizing faces, driving a car, watching television, and reading. Geographic atrophy is the most advanced form of dry AMD and is the break down of the deepest cells in the retina. Dry AMD usually occurs in both eyes, and geographic atrophy can occur in one or both eyes.
ORACEA ® (the study drug) is an investigational drug that has not been proven to be safe or helpful in patients with dry AMD. ORACEA ® is approved by the Food and Drug Administration (FDA) for the treatment of rosacea, but is not approved by the FDA for the treatment of dry AMD.
Up to 286 people will be in this study at ~40 locations in the United States. This study is sponsored and funded by the University of Virginia, Department of Ophthalmology with support from the MEDARVA Foundation. Galderma Laboratories, L.P. is supplying the drug for this study at no cost to participants.