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Genetic Testing Disclosure Timing for Age-Related Macular Degeneration (MAGENTA Trial)

Phase 2
Recruiting
Led By Paul Bernstein, MD, PhD
Research Sponsored by Paul S. Bernstein
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be between 18 and 64 years of age.
Participants must be between 18 and 64 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and month 12
Awards & highlights

MAGENTA Trial Summary

This trial will test whether or not receiving AMD genetic testing leads people to make healthier lifestyle choices as measured by their carotenoid status.

Who is the study for?
This study is for Caucasian individuals aged 18-64, with or without a family history of Age-related Macular Degeneration (AMD). It's not open to those who have AMD themselves, are non-Caucasian, work in eye care, had previous genetic testing for AMD risk, plan to have cataract surgery soon, or have major psychiatric disorders.Check my eligibility
What is being tested?
The trial is examining the effect of knowing one's genetic risk for AMD on lifestyle choices. Participants will receive their genetic test results either early or late in the study to see if and how this knowledge influences their behavior regarding eye health.See study design
What are the potential side effects?
Since this trial involves only the disclosure of genetic testing results rather than medication or procedures, there are no direct physical side effects. However, learning about personal genetic risks can sometimes cause anxiety or stress.

MAGENTA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 64 years old.
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I am between 18 and 64 years old.
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I am Caucasian, as required for the genetic test's accuracy.

MAGENTA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and month 12 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 skin carotenoid status in response to genetic risk disclosure as measured by Reflectance Spectroscopy
Change in skin carotenoid status in response to genetic risk disclosure as measured by Resonance Raman Spectroscopy
Secondary outcome measures
Chang in serum carotenoid status in response to genetic risk disclosure
Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Density
Change in ocular carotenoid status in response to genetic risk disclosure as measured by Macular Pigment Optical Volume

MAGENTA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early Genetic Results DisclosureExperimental Treatment1 Intervention
Early disclosure group receives results of genetic testing at Month 1
Group II: Late Genetic Results DisclosureActive Control1 Intervention
Late disclosure group receives results of genetic testing at Month 12

Find a Location

Who is running the clinical trial?

Paul S. BernsteinLead Sponsor
2 Previous Clinical Trials
55 Total Patients Enrolled
Paul Bernstein, MD, PhDPrincipal InvestigatorUniversity of Utah Moran Eye Center
2 Previous Clinical Trials
10,065 Total Patients Enrolled

Media Library

Early disclosure of genetic testing results Clinical Trial Eligibility Overview. Trial Name: NCT05265624 — Phase 2
Genetic Testing Research Study Groups: Early Genetic Results Disclosure, Late Genetic Results Disclosure
Genetic Testing Clinical Trial 2023: Early disclosure of genetic testing results Highlights & Side Effects. Trial Name: NCT05265624 — Phase 2
Early disclosure of genetic testing results 2023 Treatment Timeline for Medical Study. Trial Name: NCT05265624 — Phase 2

Frequently Asked Questions

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

Has the FDA approved dispensing genetic test results prior to completion?

"With limited data on efficacy, but some evidence of safety, the Early disclosure of genetic testing results has been assigned a score of 2."

Answered by AI

Are octogenarians being included in the enrollment process of this medical experiment?

"This research project is open to participants aged 18 and over, but below 64 years old."

Answered by AI

What is the enrollment quota for this research study?

"Affirmative. According to the data on clinicaltrials.gov, this study is actively searching for participants and has been since August 3rd 2022. The most recent edit was made 8 days later, on August 10th 2022, with a requirement of 80 recruits from one location."

Answered by AI

Who meets the eligibility criteria for participating in this clinical experiment?

"This research requires 80 participants of Caucasian heritage between 18 and 64 years old that have had genetic testing. It is not a requirement to show familial history of AMD, yet this could be beneficial for the study."

Answered by AI

Is enrollment currently available for this research project?

"Affirmative. According to information found on clinicaltrials.gov, this experiment is actively recruiting participants who meet its criteria and was last updated August 10th 2022. A total of 80 patients are required from 1 medical centre for the trial's completion."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Moran AMD Genetic Testing Assessment Study
Paul S. Bernstein 2022. "The Moran AMD Genetic Testing Assessment Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05265624.
All > Age Related Macular Degeneration > Macular Degeneration
~13 spots leftby Aug 2024
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