High-dose atorvastatin to improve dark adaptation in intermediate AMD

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

This trial tests whether taking high-dose atorvastatin (80 mg) can speed dark adaptation recovery in people with high-risk intermediate age-related macular degeneration.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: Massachusetts Eye and Ear Infirmary (Academic / other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04735263 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives participants high-dose atorvastatin (80 mg) and tracks retinal changes over time. The study measures dark adaptation recovery time as an early functional marker and correlates that with drusen volume changes measured by spectral-domain OCT. Participants are selected for high-risk intermediate AMD in the study eye and those with contraindications to high-dose atorvastatin are excluded. The goal is to determine if early dark adaptation improvement predicts later drusen reduction to guide treatment decisions.

Who should consider this trial

Good fit: Adults younger than 85 with high-risk intermediate AMD in one or both eyes who are not currently on or intolerant to high-dose atorvastatin are the ideal candidates.

Not a fit: Patients with advanced geographic atrophy or active neovascular AMD in the study eye, those with severe comorbidities or contraindications to statins, or those previously treated with high-dose atorvastatin are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, patients might experience earlier functional improvement and measurable drusen reduction that could help clinicians decide whether to continue or stop high-dose statin therapy.

How similar studies have performed: Small case series and observational reports have suggested drusen regression with high-dose statins, but randomized controlled evidence is limited.

Eligibility 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

Where this trial is running

Boston, Massachusetts

• Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: John B Miller, MD — Massachusetts Eye and Ear Infirmary, Harvard Medical School
• Study coordinator: John B Miller, MD

Conditions Age-related Macular Degeneration