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High-Dose Atorvastatin for Early Stage Age-Related Macular Degeneration (DELPHI Trial)
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.
DELPHI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDELPHI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DELPHI Trial Design
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Who is running the clinical trial?
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- You have active inflammation in your eye called uveitis.You have any eye condition other than age-related macular degeneration (AMD).You have had surgery on your retina in the past.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.You are currently taking cyclosporine medication.You have been taking a high dose of Atorvastatin (80 mg) in the past.You have experienced negative side effects from taking statin medications in the past.
- Group 1: Intermediate Age-Related macular degeneration patients
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 30 Other Conditions - This treatment demonstrated efficacy for 30 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
What condition does this medication commonly target?
"This treatment can help patients manage lipidemias, postoperative thromboembolism, and anginal pain."
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."
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."
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