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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
RECRUITINGChange in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT)
Determine weather improvement in dark adaptation recovery time or rod intercept time (RIT) can be used as an early indicator of positive response to high dose statin therapy for intermediate AMD patients
Time frame: 18 Months
Change in drusen volume measured by Spectral Domain OCT
To measure and quantify improvement or positive response to high dose statin therapy in patients with intermediate AMD using drusen volume measured by SDOCT
Time frame: 18 months
To correlate visual functions of dark adaption with change in drusen volume
Patient will have Dark Adaptation testing performed to check change in vision function with changes in drusen volume.
Time frame: 18 months
To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients
Patient will have Best Corrected visual acuity, testing performed to check changes in vision function
Time frame: 18 months
To correlate change in contrast sensitivity and retinal structural evaluation of study patients
Patient will have quantitative contrast sensitivity function testing performed to check change in vision function with changes in drusen volume.
Time frame: 18 months
To correlate change in microperimetry visual functional and retinal structural evaluation of study patients
Patient will have microperimetry function testing performed to check change in this vision function with changes in drusen volume
Time frame: 18 months
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