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

NCT ID: NCT04735263

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-04
• Study Completion Date: 2024-01-01

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

Detailed 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).

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Atorvastatin 80mg

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

Other Intervention Names

Lipitor 80 mg(Brand name)

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

John B. Miller, MD

Assistant Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John B Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear Infirmary, Harvard Medical School

Locations

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

John B Miller, MD

Role: CONTACT

John_miller@meei.harvard.edu

617-573-3750

Deeba Husain

Role: CONTACT

Deeba_Husain@meei.harvard.edu

617-573-3750

Facility Contacts

John B Miller, MD

Role: primary

John_Miller@meei.harvard.edu

617-573-3750

References

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.

Reference Type: BACKGROUND

PMID: 27077128 (View on PubMed)

Other Identifiers

2020P001265

Identifier Type: -

Identifier Source: org_study_id