Recruiting
Phase 2

Statin Therapy

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT04735263

Conditions

Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Atorvastatin 80mg

Study Details

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

Conditions

Age-related Macular Degeneration

Study ID

NCT04735263

Start date

Feb 4, 2021

Status verified date

Jan, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intermediate Age-Related macular degeneration patients

Subjects can have either:

1. Bilateral high-risk iAMD
2. High-risk iAMD in one eye with GA and/or CNV in the fellow eye No control arm

Interventions

Atorvastatin 80mg

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

Primary outcome measure

  • Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT) [ Time Frame: 18 Months ]
  • Change in drusen volume measured by Spectral Domain OCT [ Time Frame: 18 months ]
  • To correlate visual functions of dark adaption with change in drusen volume [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

John B Miller, MD

617-573-3750John_miller@meei.harvard.edu

Deeba Husain

617-573-3750Deeba_Husain@meei.harvard.edu

Locations

Massachusetts Eye and Ear Infirmary

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

John B Miller, MD

617-573-3750John_Miller@meei.harvard.edu

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Jan 26, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-01-26.