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

NCT04735263 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2020P001265
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• To correlate Best Corrected Visual Acuity and retinal structural evaluation of study patients

  18 months

• To correlate change in contrast sensitivity and retinal structural evaluation of study patients

  18 months

• To correlate change in microperimetry visual functional and retinal structural evaluation of study patients

  18 months

Study Arms (1)

Intermediate Age-Related macular degeneration patients

OTHER

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

Drug: Atorvastatin 80mg

Interventions

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.

Also known as: Lipitor 80 mg(Brand name)

Intermediate Age-Related macular degeneration patients

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

• Vavvas DG, Daniels AB, Kapsala ZG, Goldfarb JW, Ganotakis E, Loewenstein JI, Young LH, Gragoudas ES, Eliott D, Kim IK, Tsilimbaris MK, Miller JW. Regression of Some High-risk Features of Age-related Macular Degeneration (AMD) in Patients Receiving Intensive Statin Treatment. EBioMedicine. 2016 Feb 4;5:198-203. doi: 10.1016/j.ebiom.2016.01.033. eCollection 2016 Mar.

  PMID: 27077128 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• John B Miller, MD

  Massachusetts Eye and Ear Infirmary, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John B Miller, MD

CONTACT

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

Deeba Husain

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Model Details: Prospective interventional trial for off label use of FDA approved drug

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: February 3, 2021
• Study Start: February 4, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)