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

Age-related Macular Degeneration Clinical Trial

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

Status Recruiting

Clinical Trial Summary

interventional trial for off label use of high dose atorvastatin 80 mg in intermediate AMD patients and correlate recovery response measured by dark adaptation recovery time with drusen volume reduction measured by SD-OCT

Clinical Trial Description

Dark adaptation recovery time is a sensitive marker of AMD progression in intermediate AMD, largely owing to drusen volume providing a transport barrier that slows the transfer of nutrients between the choroid and photoreceptors2. Consequently, dark adaptation may provide an early indication of response vs. nonresponse, aiding case-by-case decisions on continuation of treatment when patients experience adverse side effects (e.g., elevated CPK or liver enzymes) or when atorvastatin provides insufficient lipid control in patients also at high-risk for cardiovascular disease (and switching to an alternative statin might be desirable). ;

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

• NCT number: NCT04735263
• Study type: Interventional
• Source: Massachusetts Eye and Ear Infirmary
• Contact: John B Miller, MD
• Phone: 617-573-3750
• Email: John_miller@meei.harvard.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: February 4, 2021
• Completion date: January 1, 2024