Trial results for 'The Moran AMD Genetic Testing Assessment Study' investigating Macular Degeneration were posted on ClinicalTrials.gov on 2025-10-01. The study enrolled 80 participants to assess the impact of genetic testing for Age-related Macular Degeneration (AMD) on lifestyle behaviors, as measured by systemic and ocular carotenoid status.
Background
Age-related Macular Degeneration (AMD) is a leading cause of vision loss among older adults. Nutritional factors, particularly carotenoids like lutein and zeaxanthin, are known to play a protective role in macular health. Genetic testing can identify individuals at higher risk for developing AMD, and understanding how the disclosure of this genetic risk influences patient behavior and subsequent nutritional biomarker levels is crucial. This study aimed to quantify these behavioral changes through objective measurements of carotenoid status in different bodily compartments.
Trial design
This completed Phase 2 study enrolled 80 participants. The trial investigated conditions including Age-Related Macular Degeneration, Genetic Testing, and Nutritional Biomarkers. The primary objective was to assess the impact of genetic testing for AMD on lifestyle behaviors, specifically as measured by systemic and ocular carotenoid status. The study design involved comparing outcomes between groups receiving early versus late genetic results disclosure.
Key results
The trial reported several key measurements related to changes in carotenoid status following genetic risk disclosure:
- Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy:
- For the 'Early Genetic Results Disclosure' group, the mean change was 257.7 (Standard Error 7.4 Reflection units (RU)).
- For the 'Late Genetic Results Disclosure' group, the mean change was 290.9 (Standard Error 12.5 Reflection units (RU)).
- Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Resonance Raman Spectroscopy:
- For the 'Early Genetic Results Disclosure' group, the mean change was 30,578.3 (Standard Error 653.6 Resonance raman units (RRU)).
- For the 'Late Genetic Results Disclosure' group, the mean change was 31,678.6 (Standard Error 1,066.5 Resonance raman units (RRU)).
- Change in Ocular Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Macular Pigment Optical Volume:
- For the 'Early Genetic Results Disclosure' group, the mean change was 10,622.6 (Standard Error 173.0 unitless).
- For the 'Late Genetic Results Disclosure' group, the mean change was 10,566.1 (Standard Error 290.0 unitless).
- Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure (first measurement):
- For the 'Early Genetic Results Disclosure' group, the mean change was 238.3 (Standard Error 17.2 nanograms per milliliter (ng/mL)).
- For the 'Late Genetic Results Disclosure' group, the mean change was 279.2 (Standard Error 29.9 nanograms per milliliter (ng/mL)).
- Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure (second measurement):
- For the 'Early Genetic Results Disclosure' group, the mean change was 618.0 (Standard Error 47.6 nanograms per milliliter (ng/mL)).
- For the 'Late Genetic Results Disclosure' group, the mean change was 818.7 (Standard Error 82.7 nanograms per milliliter (ng/mL)).
What this means
The results from 'The Moran AMD Genetic Testing Assessment Study' provide insights into how the timing of genetic risk disclosure for Macular Degeneration may influence an individual's carotenoid status. The measurements of changes in skin, ocular, and serum carotenoid levels suggest that genetic information can correlate with changes in these nutritional biomarkers. These findings contribute to understanding the potential behavioral impact of genetic testing in the context of AMD prevention and management, particularly regarding dietary and lifestyle modifications aimed at increasing carotenoid intake.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05265624, titled "The Moran AMD Genetic Testing Assessment Study", were posted on 2025-10-01 on clinicaltrials.gov.