Last updated: October 7, 2021
Sponsor: Massachusetts Eye and Ear Infirmary
Overall Status: Active - Recruiting
Phase
2
Condition
Geographic Atrophy
Aging
Myopic Macular Degeneration
Treatment
N/AClinical Study ID
NCT04735263
2020P001265
Ages 50-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 withoutpigmentary 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 thefellow eye.
Exclusion
Exclusion Criteria:
- Patient previously taking high dose Atorvastatin 80 mg
- Patients previously taking other statins than high dose atorvastatin, in whom primarycare provider (PCP) feels cannot be safely moved to high dose atorvastatin or those inwhich 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 thananti angiogenic injection, laser) within the 90 days prior to enrollment
Study Design
Total Participants: 21
Study Start date:
February 04, 2021
Estimated Completion Date:
January 01, 2024
Study Description
Connect with a study center
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts 02114
United StatesActive - Recruiting
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