21 Participants Needed

High-Dose Atorvastatin for Early Stage Age-Related Macular Degeneration

(DELPHI Trial)

JB
DH
Overseen ByDeeba Husain
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Massachusetts Eye and Ear Infirmary
Must be taking: High dose atorvastatin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether high-dose atorvastatin, a medication typically used to lower cholesterol, can aid individuals with early-stage age-related macular degeneration (AMD) by improving vision recovery and reducing drusen (fatty deposits under the retina). The focus is on individuals with intermediate AMD, particularly those with numerous drusen in their eyes. Candidates may qualify if diagnosed with intermediate AMD in one or both eyes and are not already taking high-dose atorvastatin. The trial aims to determine if this treatment can slow or improve the progression of AMD. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking cyclosporine or have been on high-dose atorvastatin or other statins that your doctor thinks you can't switch from safely.

Is there any evidence suggesting that high-dose atorvastatin is likely to be safe for humans?

Research has shown that high doses of atorvastatin, a medication commonly used to lower cholesterol, may help treat age-related macular degeneration (AMD). One study found that patients with high-risk AMD improved when taking 80 mg of atorvastatin, suggesting the treatment might help reduce fat deposits in the eye.

Atorvastatin is generally safe for many people and is already approved by the FDA for cholesterol management, so its safety is well-known. However, high doses might cause side effects like muscle pain or digestive issues. Participants should monitor for any side effects if joining a trial using higher doses than usual.12345

Why do researchers think this study treatment might be promising for AMD?

Unlike the standard treatments for age-related macular degeneration (AMD), which primarily focus on managing symptoms and slowing progression with options like anti-VEGF injections, Atorvastatin offers a unique approach. Researchers are excited about Atorvastatin because it is a high-dose cholesterol-lowering drug that might reduce the lipid deposits in the retina, potentially slowing down or even halting the disease's progression. This new angle on targeting lipid metabolism could offer a novel pathway for treating intermediate AMD, distinguishing it from current therapies that focus on different mechanisms.

What evidence suggests that high-dose atorvastatin might be an effective treatment for age-related macular degeneration?

Research suggests that a high dose of atorvastatin, a type of medication, might benefit people with intermediate age-related macular degeneration (AMD). Studies have shown that taking 80 mg of atorvastatin can reduce drusen, the fatty deposits in the eye associated with AMD. This reduction might also improve vision for some patients. Another study found that high doses of statins, like atorvastatin, were linked to a lower risk of developing AMD over time. While these findings are promising, not all studies agree on the effectiveness of statins for AMD. Participants in this trial will receive high-dose atorvastatin to evaluate its effects on intermediate AMD.13456

Who Is on the Research Team?

JB

John B Miller, MD

Principal Investigator

Massachusetts Eye and Ear Infirmary, Harvard Medical School

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.
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.
You have either advanced age-related macular degeneration (AMD) in both eyes, or advanced AMD in one eye with certain complications in the other eye.

Exclusion Criteria

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 severe renal disease or multiple comorbidities
Age >85 years
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive high dose atorvastatin 80 mg to assess dark adaptation recovery time and drusen volume reduction

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Atorvastatin

Trial Overview

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.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

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

Atorvastatin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Lipitor for:
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Approved in United States as Lipitor for:
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Approved in Canada as Lipitor for:
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Approved in Japan as Lipitor for:
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Approved in China as Lipitor for:
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Approved in Switzerland as Lipitor for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials
115
Recruited
15,000+

Citations

Statins for age‐related macular degeneration - PMC - NIH

At three years, low‐quality evidence showed an effect of simvastatin in slowing progression of AMD compared with placebo to be uncertain (odds ratio 0.51, 95% ...

Patients with High-Risk Macular Degeneration Show ...

The researchers found evidence that treatment with high-dose atorvastatin (80mg) is associated with regression of lipid deposits and improvement ...

Statin Potency Modulates Protective Effects Against AMD

High-intensity statin users exhibited a significant reduction in the risk of developing AMD at both three years (hazard ratio, HR: 0.74) and ...

The Relationship between Statin and Risk of Age‐Related ...

According to the results of this study, taking statins does not increase or decrease the risk of AMD development.

Regression of Some High-risk Features of Age-related ...

Here we present the first evidence that treatment with high dose atorvastatin may result in regression of drusen and improvement of visual acuity (VA) in ...

The association between statin use and risk of age-related ...

These results demonstrated that statin use was protective for early and exudative AMD. Additional large prospective cohort studies and RCTs are ...