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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Treatments: Atorvastatin

Criteria

Inclusion Criteria:

• All subjects with intermediate AMD diagnosis in one or both eyes will be considered, regardless the severity stage and subtype of disease in the other eye.

High-risk iAMD (numerous large, confluent drusen covering ≥ 0.5 disk area, with or without pigmentary changes but having no evidence of GA or CNV) in the study eye

Subjects can have either:

(i) Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.

Exclusion Criteria:

• Patient previously taking high dose Atorvastatin 80 mg

• Patients previously taking other statins than high dose atorvastatin, in whom primary care provider (PCP) feels cannot be safely moved to high dose atorvastatin or those in which high dose atorvastatin is deemed contraindicated by PCP

• Patients with known adverse reaction to statins

• Patients with severe renal disease or multiple comorbidities

• Age >85 years

• Pregnancy

• Patients with concomitant use of cyclosporine

• Active uveitis;

• Ocular infection;

• Any retinopathy other than AMD;

• Media opacities;

• Refractive error equal or superior to 6 diopters (spherical equivalent);

• Any previous retina surgery;

• Other ocular surgery or intra-ocular procedure in the study eye (injection other than anti angiogenic injection, laser) within the 90 days prior to enrollment