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

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/A

Clinical Study ID

NCT04735263
2020P001265
  • Ages 50-85
  • All Genders

Study 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

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

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).

Connect with a study center

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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