What is the mechanism of action of this treatment?

High-dose atorvastatin, a statin, works by inhibiting HMG-CoA reductase, an enzyme crucial for cholesterol synthesis. This reduction in cholesterol levels can lead to a decrease in drusen volume in the retina, which is significant in the progression of Age-Related Macular Degeneration (AMD). Other common treatments include anti-VEGF therapies that inhibit abnormal blood vessel growth and leakage in the retina. These treatments are essential for AMD patients as they target the underlying mechanisms of the disease, potentially slowing its progression and helping to preserve vision.

What side effects are associated with this type of intervention?

Common treatments for Age-Related Macular Degeneration (AMD) include statins like high-dose atorvastatin, which are being studied for their potential to reduce drusen volume and improve dark adaptation recovery time. Statins are generally well-tolerated but can cause side effects such as muscle pain, liver enzyme abnormalities, and, rarely, muscle damage. Other treatments for AMD, such as anti-VEGF injections (e.g., ranibizumab, aflibercept), can cause ocular side effects like increased intraocular pressure, retinal detachment, and endophthalmitis. Photodynamic therapy and laser treatments may also be used, with potential side effects including vision loss and scarring. Overall, while statins have a relatively mild side effect profile, other AMD treatments can have more serious ocular complications.

What prior FDA approvals exist?

Currently, there is no evidence from the provided context that statins like atorvastatin or simvastatin have received FDA approval specifically for the treatment of Age-Related Macular Degeneration (AMD). The context mentions that available randomized controlled trials (RCTs) have not shown a significant difference in visual outcomes for AMD patients treated with statins compared to placebo. Therefore, while statins are being studied for their potential benefits in AMD, they are not yet approved for this use. Other FDA-approved treatments for AMD include anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab, aflibercept, and bevacizumab, which are used to manage the neovascular (wet) form of AMD.

What other types of research exist?

Promising novel alternatives to high-dose atorvastatin for Age-Related Macular Degeneration patients include PCSK9 inhibitors (evolocumab and alirocumab) and inclisiran. These treatments have shown significant efficacy in lowering LDL cholesterol levels and may offer additional cardiovascular benefits.

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HMG-CoA Reductase Inhibitor

High-Dose Atorvastatin for Early Stage Age-Related Macular Degeneration (DELPHI Trial)

Phase 2

Waitlist Available

Led By John B Miller, MD

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Summary

This trial uses a high dose of atorvastatin (80 mg) to treat patients with a certain eye condition. The goal is to reduce deposits in the eye, which can help improve vision in low light conditions and slow the progression of the disease. Preliminary studies have shown significant improvement in patients taking this high-dose treatment.

Who is the study for?

This trial is for people with a condition called intermediate Age-Related Macular Degeneration (iAMD), where the eye has many large drusen (yellow deposits). Participants must not have advanced AMD, be on high-dose Atorvastatin already, or have other serious health issues. They should also not be over 85 years old or pregnant.

What is being tested?

The study tests if a high dose of Atorvastatin (80mg) can improve night vision recovery time and reduce drusen size in iAMD patients. It's an interventional trial to see how well this cholesterol-lowering drug might work off-label for AMD.

What are the potential side effects?

Atorvastatin may cause muscle pain, digestive problems, increased blood sugar levels, liver enzyme changes, and memory loss or confusion. However, individual reactions to the medication can vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Dark Adaptation recovery time measured by change in Rod Intercept time (RIT)

Change in drusen volume measured by Spectral Domain OCT

To correlate visual functions of dark adaption with change in drusen volume

Secondary study objectives

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

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

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intermediate Age-Related macular degeneration patientsExperimental Treatment1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Atorvastatin

FDA approved

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

High-dose atorvastatin, a statin, works by inhibiting HMG-CoA reductase, an enzyme crucial for cholesterol synthesis. This reduction in cholesterol levels can lead to a decrease in drusen volume in the retina, which is significant in the progression of Age-Related Macular Degeneration (AMD). Other common treatments include anti-VEGF therapies that inhibit abnormal blood vessel growth and leakage in the retina. These treatments are essential for AMD patients as they target the underlying mechanisms of the disease, potentially slowing its progression and helping to preserve vision.

The relationship between statin use and open-angle glaucoma.Fibrates and statins in the treatment of diabetic retinopathy.

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor

108 Previous Clinical Trials

13,013 Total Patients Enrolled

John B Miller, MDPrincipal InvestigatorMassachusetts Eye and Ear Infirmary, Harvard Medical School

Media Library

Atorvastatin (HMG-CoA Reductase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04735263 — Phase 2

Age-Related Macular Degeneration Research Study Groups: Intermediate Age-Related macular degeneration patients

Age-Related Macular Degeneration Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT04735263 — Phase 2

Atorvastatin (HMG-CoA Reductase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04735263 — Phase 2

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