NCT04735263

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Atorvastatin 80mg	Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.

Timeline

• Start date: 2021-02-04
• Primary completion: 2027-04-01
• Completion: 2028-01-01
• First posted: 2021-02-03
• Last updated: 2026-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study