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

  • End date
    Jan 1, 2024
  • participants needed
  • sponsor
    Massachusetts Eye and Ear Infirmary
Updated on 22 October 2021
spectral domain optical coherence tomography


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


Dark adaptation recovery time is a sensitive marker of AMD progression in intermediate AMD, largely owing to drusen volume providing a transport barrier that slows the transfer of nutrients between the choroid and photoreceptors2. Consequently, dark adaptation may provide an early indication of response vs. nonresponse, aiding case-by-case decisions on continuation of treatment when patients experience adverse side effects (e.g., elevated CPK or liver enzymes) or when atorvastatin provides insufficient lipid control in patients also at high-risk for cardiovascular disease (and switching to an alternative statin might be desirable).

Condition Macular Degeneration, age-related macular degeneration
Treatment Atorvastatin 80mg
Clinical Study IdentifierNCT04735263
SponsorMassachusetts Eye and Ear Infirmary
Last Modified on22 October 2021


Yes No Not Sure

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
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
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