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

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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).

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

Conditions
-----------------
Age-related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Atorvastatin 80mg


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective interventional trial for off label use of FDA approved drug
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intermediate Age-Related macular degeneration patients<br>Subjects can have either: Bilateral high-risk iAMD High-risk iAMD in one eye with GA and/or CNV in the fellow eye No control arm | Drug: Atorvastatin 80mg<br>* Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.<br>* Other names: Lipitor 80 mg(Brand name);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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 | 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 | 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 18 months |