What this study is
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
What's being tested
- Atorvastatin 80mg
Intervention · DRUG
Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.
Study details
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Conditions
- Age-related Macular Degeneration
- Enrolling
- 21 people
- Starts
- 2021-02-04
- Est. completion
- 2028-01-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years – 85 YearsSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- 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
You can't join if
- 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
Subjects can have either
You may qualify if
- (i) Bilateral high-risk iAMD, or (ii) High-risk iAMD in one eye with GA and/or CNV in the fellow eye.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMassachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
- John B Miller, MD · Contact617-573-3750John_Miller@meei.harvard.edu
Recruiting
Study team
Sponsor
Massachusetts Eye and Ear Infirmary
Study ID 2020P001265
Principal investigator
John B Miller, MD
Massachusetts Eye and Ear Infirmary, Harvard Medical School
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.