High-dose atorvastatin to improve dark adaptation in intermediate AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: John_miller@meei.harvard.edu
• Phone: 617-573-3750

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding Age-Related Macular Degeneration and Its Progression

  This study looks at how age-related macular degeneration develops and progresses by comparing people with the condition to healthy individuals, using non-invasive tests and personal feedback.

  Recruiting Center for Eye Research Australia · East Melbourne, Victoria · NCT04739319

• Blepharoptosis After Repeated Anti-VEGF Injections in One Eye

  This study tests whether repeated intravitreal anti-VEGF injections in one eye affect eyelid position compared with the untreated fellow eye.

  Recruiting Fatih Sultan Mehmet Training and Research Hospital · Istanbul · NCT07821450

• First-in-human test of ARO-033 in adults

  This study tests whether ARO-033 is safe and tolerable, and how it behaves in the body, in healthy adults and in adults with age-related macular degeneration.

  Recruiting Phase 1 Arrowhead Pharmaceuticals · Auckland · NCT07662096

• Predicting Risk of AMD Progression Using Imaging in Aging Eyes

  Researchers are test a new screening approach to detect early AMD and monitor its progression in adults 55 and older, to see if personalized monitoring can help in community settings.

  Recruiting at 2 sites Singapore National Eye Centre · Singapore and 1 other locations · NCT07653269

• C.001 for retinal degeneration: a first-in-human dose-escalation safety test

  A first-in-human study will test the safety and tolerability of a single subretinal injection of C.001 in adults with retinal diseases involving retinal pigment epithelium degeneration.

  Recruiting at 2 sites Phase 1 Cellio Therapeutics Inc · Beverly Hills, California and 2 other locations · NCT07594236

• Central microperimetry and radial OCT in geographic atrophy

  We will test whether central microperimetry and radial OCT scans can more accurately measure how geographic atrophy progresses toward the fovea in people with or at risk for GA from age-related macular degeneration.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07556406

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.