Actively Recruiting

Phase 2
Age: 50Years - 85Years
All Genders
NCT04735263

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

Led by Massachusetts Eye and Ear Infirmary · Updated on 2026-01-26

21

Participants Needed

1

Research Sites

360 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All subjects with intermediate AMD diagnosis in one or both eyes, regardless of severity stage or subtype in the other eye
  • Presence of high-risk intermediate AMD with numerous large, confluent drusen covering 60.5 disk area, with or without pigmentary changes, but no geographic atrophy or choroidal neovascularization in the study eye
  • Subjects may have either bilateral high-risk intermediate AMD or high-risk intermediate AMD in one eye with geographic atrophy and/or choroidal neovascularization in the other eye
  • Age between 50 and 85 years
Not Eligible

You will not qualify if you...

  • Previous use of high-dose atorvastatin (80 mg)
  • Previous use of other statins if primary care provider feels patient cannot be safely switched to high-dose atorvastatin or if high-dose atorvastatin is contraindicated
  • Known adverse reaction to statins
  • Severe renal disease or multiple comorbidities
  • Age over 85 years
  • Pregnancy
  • Use of cyclosporine
  • Active uveitis
  • Ocular infection
  • Any retinopathy other than AMD
  • Media opacities affecting the eye
  • Refractive error equal to or greater than 6 diopters (spherical equivalent)
  • History of retina surgery
  • Other ocular surgery or intraocular procedures (except anti-angiogenic injections or laser) in the study eye within 90 days before enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

J

John B Miller, MD

CONTACT

D

Deeba Husain

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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