Phase 2
N=80
The Moran AMD Genetic Testing Assessment Study
Age-Related Macular Degeneration · Genetic Testing · Nutritional Biomarkers
Bottom Line
View on ClinicalTrials.gov: NCT05265624 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy — 257.7; 290.9 Reflection units (RU)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Early disclosure of genetic testing results (Behavioral); Late disclosure of genetic testing results (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paul S. Bernstein
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy |
257.7; 290.9 | — |
| PRIMARY Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Resonance Raman Spectroscopy |
30,578.3; 31,678.6 | — |
| SECONDARY Change in Ocular Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Macular Pigment Optical Volume |
10,622.6; 10,566.1 | — |
| SECONDARY Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure |
238.3; 279.2; 618.0; 818.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05265624). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.