Using Dark Adaptation to Track Response to High-Dose Atorvastatin Treatment in Intermediate Age-Related Macular Degeneration

What this Trial Is About

Researchers are studying the use of high-dose atorvastatin 80 mg in patients with intermediate age-related macular degeneration AMD to see if it can improve dark adaptation recovery time and reduce drusen volume in the eye. This phase 2 interventional trial aims to correlate how well patients recover their vision in low light with changes in drusen, which are deposits that can block nutrient flow and worsen AMD. The study seeks to provide early indications of treatment response to help guide care decisions, especially when considering side effects or alternative treatments. Participants will receive 80 mg of atorvastatin daily if they tolerate it throughout the study. Eligible patients have either bilateral high-risk intermediate AMD or high-risk intermediate AMD in one eye with geographic atrophy GA or choroidal neovascularization CNV in the other eye. There is no control group in this trial. The treatment and observations will continue over an 18-month period. During the study, participants will have their dark adaptation recovery time measured by rod intercept time and drusen volume assessed using spectral domain optical coherence tomography SD-OCT. Additional evaluations will include best corrected visual acuity, contrast sensitivity, and microperimetry to assess visual function and retinal structure. These assessments will occur throughout the 18 months to monitor changes and safety under medical supervision.

Dark Adaptation as an Early Indicator of Response to Statin Therapy for Intermediate AMD