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

Mass Eye and Ear

Status and phase: Enrolling; Phase 2

Conditions: Age-related Macular Degeneration

Treatments: Drug: Atorvastatin 80mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04735263

2020P001265

Details and patient eligibility

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

Full 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).

Enrollment: 21 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Intermediate Age-Related macular degeneration patients

Other group

Description:

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

Treatment:

Drug: Atorvastatin 80mg