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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
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.
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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

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
106 Previous Clinical Trials
12,928 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being given this medication as part of the research project?

"That is correct. The clinicaltrials.gov website has the most recent information regarding this study, which was posted on February 4th, 2021 and updated as recently as October 7th, 2021. Currently, they are admitting 21 patients from 1 site."

Answered by AI

Are people currently signing up to participate in this research?

"The study is still recruiting patients, if the information provided on clinicaltrials.gov is accurate. The trial was initially posted on February 4th 2021 and last updated October 7th 2021."

Answered by AI

What are the basic requirements for subjects of this experiment?

"The current clinical trial has a requirement that patients must be between 50-85 years old and have macular degeneration. Around 21 individuals will be accepted into the study."

Answered by AI

Is this trial open to people who are not yet 50 years old?

"According to the inclusion criteria laid out by the researchers, only patients aged 50 to 85 can enroll in this trial. There are 15 other clinical trials available for people under 18 and 229 for senior citizens."

Answered by AI

What condition does this medication commonly target?

"This treatment can help patients manage lipidemias, postoperative thromboembolism, and anginal pain."

Answered by AI

Has this medication been greenlit by the FDA?

"While there is some data supporting the safety of this treatment, it received a score of 2 because Phase 2 trials have yet to produce evidence of efficacy."

Answered by AI

Is this research the inaugural project of its type?

"As of now, there are 73 on-going studies for this medication in 28 countries and 162 cities. The first study was conducted in 2005 by Merck Sharp & Dohme LLC. It reached Phase 4 drug approval stage after 80 patients completed the trial. From 2005 to present day, a total of 464 studies have been completed."

Answered by AI
~5 spots leftby Mar 2025