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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorMassachusetts Eye and Ear Infirmary

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Atorvastatin 80mg

    Drug

    Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.

Treatment groups

21 Participants
are divided into 1 treatment group
Group A: Intermediate Age-Related macular degeneration patientsOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
18 Months
2

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
3

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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