Age-Related Macular DegenerationPhase 2MAGENTANCT05265624

The Moran AMD Genetic Testing Assessment Study

A Phase 2 study testing Early disclosure of genetic testing results and Late disclosure of genetic testing results in people with Age-Related Macular Degeneration and Genetic Testing, run by Paul S. Bernstein at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goals of this study are: To assess the impact of genetic testing for Age-related Macular Degeneration (AMD) on lifestyle behaviors as measured by systemic and ocular carotenoid status. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Age-Related Macular Degeneration, Genetic Testing, Nutritional Biomarkers
What is being tested?: Early disclosure of genetic testing results and Late disclosure of genetic testing results
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 3 Aug 2022to 12 Jul 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants must be between 18 and 64 years of age.
They must also be Caucasian as this genetic test is only validated in Caucasians.
They can have a positive family history of AMD but this is not necessary.

Who cannot join

Personal history of AMD
Non Caucasian
Employee of the Moran or other eye care practice (likely to have more knowledge about AMD than a layperson)
Personal history of prior genetic testing for AMD risk
Anticipated cataract surgery in the upcoming year (can affect Macular Pigment measurement)
Major psychiatric disorder

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah John A. Moran Eye Center
Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: A Phase 2 Study of the Value of Pre-symptomatic Genetic Risk Assessment for Age-Related Macular Degeneration

The goals of this study are:

To assess the impact of genetic testing for Age-related Macular Degeneration (AMD) on lifestyle behaviors as measured by systemic and ocular carotenoid status.

Conditions: Age-Related Macular Degeneration, Genetic Testing, Nutritional Biomarkers
Being tested: Early disclosure of genetic testing results, Late disclosure of genetic testing results
Medical subject headings: Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early disclosure of genetic testing resultsBehavioural
Early disclosure group receives results of genetic testing at Month 1
Late disclosure of genetic testing resultsBehavioural
Late disclosure group receives results of genetic testing at Month 12

Study groups in NCT05265624
Study group	Role	What they receive
Early Genetic Results Disclosure	Experimental	Early disclosure group receives results of genetic testing at Month 1 Receives: Behavioral: Early disclosure of genetic testing results
Late Genetic Results Disclosure	Active comparator	Late disclosure group receives results of genetic testing at Month 12 Receives: Behavioral: Late disclosure of genetic testing results

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy
Reflectance Spectroscopy (RS) is measured by Reflection Units. Possible scores range from 0 (no carotenoids detected) to greater than 500. Change = (Month 12 Score - Baseline Score).
Measured: Baseline and Month 12
Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Resonance Raman Spectroscopy
Resonance Raman Spectroscopy (RSS) is measured in Resonance Raman Units (RRU). Possible scores range from 0 (no carotenoids detected) to greater than 100,000. Change = (Month 12 Score - Baseline Score).
Measured: Baseline and Month 12

Secondary outcomes (2)

Change in Ocular Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Macular Pigment Optical Volume
Macular Pigment Optical Volume (MPOV) is a unitless measure of the amount of carotenoids present in the macula. Possible scores range from 0 (no carotenoids detected) to greater than 50,000. Change = (Month 12 Score - Baseline Score).
Measured: Baseline and Month 12
Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure
Serum carotenoid levels are measured in nanograms per milliliter (ng/mL). Possible scores range from 0 (no carotenoids detected) to greater than 1,000. Change = (Month 12 Score - Baseline Score).
Measured: Baseline and Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 202212 Jul 2024

First posted3 Mar 2022
Study start3 Aug 2022
Primary completion12 Jul 2024
Study completion12 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05265624
Sponsor's protocol ID: 150093
Other IDs: 1R21EY033579
Acronym: MAGENTA
Status last verified: Sep 2025
First submitted: 8 Feb 2022
Last updated: 1 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Addo EK, Hartnett ME, Bernstein PS. The value of pre-symptomatic genetic risk assessment for age-related macular degeneration: the Moran AMD Genetic Testing Assessment (MAGENTA) study-a study protocol for a randomized controlled trial. Trials. 2023 Jun 19;24(1):414. doi: 10.1186/s13063-023-07436-4.
PubMed 37337222

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Geographic Atrophy Secondary to Age-Related Macular Degeneration
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
Enrolling by invitation
Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study
Geographic Atrophy
Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Age-Related Macular Degeneration

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of the Value of Pre-symptomatic Genetic Risk Assessment for Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT05265624
Acronym / sponsor ID: MAGENTA / 150093
Conditions: Age-Related Macular Degeneration, Genetic Testing, Nutritional Biomarkers
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Paul S. BernsteinUniversity, hospital or other
Collaborators: National Eye Institute (NEI)
Study start: 3 Aug 2022 (actual)
Primary completion: 12 Jul 2024 (actual)
Study completion: 12 Jul 2024 (actual)
First posted: 3 Mar 2022 (actual)
Results: Posted 1 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goals of this study are:

To assess the impact of genetic testing for Age-related Macular Degeneration (AMD) on lifestyle behaviors as measured by systemic and ocular carotenoid status.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Early Genetic Results Disclosure	Experimental	Behavioral: Early disclosure of genetic testing resultsEarly disclosure group receives results of genetic testing at Month 1
Late Genetic Results Disclosure	Active comparator	Behavioral: Late disclosure of genetic testing resultsLate disclosure group receives results of genetic testing at Month 12

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Participants must be between 18 and 64 years of age.
They must also be Caucasian as this genetic test is only validated in Caucasians.
They can have a positive family history of AMD but this is not necessary.

Key exclusion criteria (6 listed)

Personal history of AMD
Non Caucasian
Employee of the Moran or other eye care practice (likely to have more knowledge about AMD than a layperson)
Personal history of prior genetic testing for AMD risk
Anticipated cataract surgery in the upcoming year (can affect Macular Pigment measurement)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Early disclosure of genetic testing resultsEarly disclosure group receives results of genetic testing at Month 1	Behavioural	Early Genetic Results Disclosure
Late disclosure of genetic testing resultsLate disclosure group receives results of genetic testing at Month 12	Behavioural	Late Genetic Results Disclosure

Primary outcome

Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy
Time frame: Baseline and Month 12
Reflectance Spectroscopy (RS) is measured by Reflection Units. Possible scores range from 0 (no carotenoids detected) to greater than 500. Change = (Month 12 Score - Baseline Score).
Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Resonance Raman Spectroscopy
Time frame: Baseline and Month 12
Resonance Raman Spectroscopy (RSS) is measured in Resonance Raman Units (RRU). Possible scores range from 0 (no carotenoids detected) to greater than 100,000. Change = (Month 12 Score - Baseline Score).

2 secondary outcomes

Change in Ocular Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Macular Pigment Optical Volume
Time frame: Baseline and Month 12
Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure
Time frame: Baseline and Month 12

Results and safety

Results posted to the registry on 1 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early Genetic Results Disclosure	60	56
Late Genetic Results Disclosure	20	20

Primary outcome: Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy

Time frame: Baseline and Month 12. Mean (Standard Error). Unit: Reflection units (RU)

Measure	Early Genetic Results Disclosure n = 56	Late Genetic Results Disclosure n = 20
Value	257.7 (7.4)	290.9 (12.5)

Primary outcome: Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Resonance Raman Spectroscopy

Time frame: Baseline and Month 12. Mean (Standard Error). Unit: Resonance raman units (RRU)

Measure	Early Genetic Results Disclosure n = 56	Late Genetic Results Disclosure n = 20
Value	30,578.3 (653.6)	31,678.6 (1,066.5)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early Genetic Results Disclosure	0 of 60 (0%)	18 of 60 (30%)	0 of 60
Late Genetic Results Disclosure	0 of 20 (0%)	2 of 20 (10%)	0 of 20

Limitations and caveats (from the sponsor): Our study population was mainly Caucasian because the genetic testing had been validated in this population. Due to logistical constraints, we could not undertake expanded measures of lifestyle modification and coaching, potential active nutritional interventions, or follow-up with individuals in the deferred disclosure group to determine any psychological impact.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37337222Addo EK, Hartnett ME, Bernstein PS. The value of pre-symptomatic genetic risk assessment for age-related macular degeneration: the Moran AMD Genetic Testing Assessment (MAGENTA) study-a study protocol for a randomized controlled trial. Trials. 2023 Jun 19;24(1):414. doi: 10.1186/s13063-023-07436-4.
Individual participant dataSharing planned: No

Related trials for Age-Related Macular Degeneration

RecruitingPhase 2
A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Geographic Atrophy Secondary to Age-Related Macular Degeneration
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Active, not recruitingPhase 3
4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration
Macular Neovascularization Secondary to Age-Related Macular Degeneration
Enrolling by invitation
Adaptive Optics Scanning Light Ophthalmoscopy (AOSLO) and Microperimetry (MP) Sub-study
Geographic Atrophy
Active, not recruitingPhase 1/2
Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration
Age-Related Macular Degeneration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paul Bernstein, MD, PhD principal investigator

University of Utah Moran Eye Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy (time frame: Baseline and Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05265624, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.