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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

DELPHI Trial Summary

This trial is testing whether a high dose of atorvastatin can help people with early stage age-related macular degeneration, and whether there is a correlation between the drug's effectiveness and the size of drusen in the eye.

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.Check my eligibility
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.See study design
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.

DELPHI Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

DELPHI Trial Design

1Treatment groups
Experimental Treatment
Group I: Intermediate Age-Related macular degeneration patientsExperimental Treatment1 Intervention
Subjects can have either: Bilateral high-risk iAMD 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

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
107 Previous Clinical Trials
12,965 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
~5 spots leftby Jun 2025
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