Trial Outcomes & Findings for The Moran AMD Genetic Testing Assessment Study (NCT NCT05265624)
NCT ID: NCT05265624
Last Updated: 2025-10-01
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
Baseline and Month 12
Results posted on
2025-10-01
Participant Flow
Participant milestones
| Measure |
Early Genetic Results Disclosure
Early disclosure group receives results of genetic testing at Month 1
Early disclosure of genetic testing results: Early disclosure group receives results of genetic testing at Month 1
|
Late Genetic Results Disclosure
Late disclosure group receives results of genetic testing at Month 12
Late disclosure of genetic testing results: Late disclosure group receives results of genetic testing at Month 12
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
20
|
|
Overall Study
COMPLETED
|
56
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Early Genetic Results Disclosure
Early disclosure group receives results of genetic testing at Month 1
Early disclosure of genetic testing results: Early disclosure group receives results of genetic testing at Month 1
|
Late Genetic Results Disclosure
Late disclosure group receives results of genetic testing at Month 12
Late disclosure of genetic testing results: Late disclosure group receives results of genetic testing at Month 12
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The Moran AMD Genetic Testing Assessment Study
Baseline characteristics by cohort
| Measure |
Early Genetic Results Disclosure
n=60 Participants
Early disclosure group receives results of genetic testing at Month 1
Early disclosure of genetic testing results: Early disclosure group receives results of genetic testing at Month 1
|
Late Genetic Results Disclosure
n=20 Participants
Late disclosure group receives results of genetic testing at Month 12
Late disclosure of genetic testing results: Late disclosure group receives results of genetic testing at Month 12
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
51.3 years
STANDARD_DEVIATION 10.3 • n=107 Participants
|
48.6 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
20 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Skin carotenoid status at baseline by RS
|
269 Reflection Units (RU)
STANDARD_DEVIATION 113.5 • n=99 Participants
|
261 Reflection Units (RU)
STANDARD_DEVIATION 101.1 • n=107 Participants
|
267.5 Reflection Units (RU)
STANDARD_DEVIATION 110 • n=206 Participants
|
|
Skin carotenoid status at baseline by RRS
|
27,865 Resonance Raman Units (RRU)
STANDARD_DEVIATION 9,089.6 • n=99 Participants
|
27,185 Resonance Raman Units (RRU)
STANDARD_DEVIATION 7,470.3 • n=107 Participants
|
27,695.5 Resonance Raman Units (RRU)
STANDARD_DEVIATION 8,672.6 • n=206 Participants
|
|
Macular carotenoid status at baseline
|
10,252 unitless
STANDARD_DEVIATION 4,861.3 • n=99 Participants
|
9,945 unitless
STANDARD_DEVIATION 4,286.7 • n=107 Participants
|
10,175.5 unitless
STANDARD_DEVIATION 4,699.6 • n=206 Participants
|
|
Serum carotenoid status at baseline
|
623.9 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 357.2 • n=99 Participants
|
541.8 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 247.3 • n=107 Participants
|
603.3 nanograms per milliliter (ng/mL)
STANDARD_DEVIATION 333.6 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 12Reflectance 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).
Outcome measures
| Measure |
Early Genetic Results Disclosure
n=56 Participants
Early disclosure group receives results of genetic testing at Month 1
Early disclosure of genetic testing results: Early disclosure group receives results of genetic testing at Month 1
|
Late Genetic Results Disclosure
n=20 Participants
Late disclosure group receives results of genetic testing at Month 12
Late disclosure of genetic testing results: Late disclosure group receives results of genetic testing at Month 12
|
|---|---|---|
|
Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Reflectance Spectroscopy
|
257.7 Reflection units (RU)
Standard Error 7.4
|
290.9 Reflection units (RU)
Standard Error 12.5
|
PRIMARY outcome
Timeframe: Baseline and Month 12Resonance 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).
Outcome measures
| Measure |
Early Genetic Results Disclosure
n=56 Participants
Early disclosure group receives results of genetic testing at Month 1
Early disclosure of genetic testing results: Early disclosure group receives results of genetic testing at Month 1
|
Late Genetic Results Disclosure
n=20 Participants
Late disclosure group receives results of genetic testing at Month 12
Late disclosure of genetic testing results: Late disclosure group receives results of genetic testing at Month 12
|
|---|---|---|
|
Change in Skin Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Resonance Raman Spectroscopy
|
30,578.3 Resonance raman units (RRU)
Standard Error 653.6
|
31,678.6 Resonance raman units (RRU)
Standard Error 1,066.5
|
SECONDARY outcome
Timeframe: Baseline and Month 12Macular 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).
Outcome measures
| Measure |
Early Genetic Results Disclosure
n=56 Participants
Early disclosure group receives results of genetic testing at Month 1
Early disclosure of genetic testing results: Early disclosure group receives results of genetic testing at Month 1
|
Late Genetic Results Disclosure
n=20 Participants
Late disclosure group receives results of genetic testing at Month 12
Late disclosure of genetic testing results: Late disclosure group receives results of genetic testing at Month 12
|
|---|---|---|
|
Change in Ocular Carotenoid Status in Response to Genetic Risk Disclosure as Measured by Macular Pigment Optical Volume
|
10,622.6 unitless
Standard Error 173.0
|
10,566.1 unitless
Standard Error 290.0
|
SECONDARY outcome
Timeframe: Baseline and Month 12Serum 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).
Outcome measures
| Measure |
Early Genetic Results Disclosure
n=56 Participants
Early disclosure group receives results of genetic testing at Month 1
Early disclosure of genetic testing results: Early disclosure group receives results of genetic testing at Month 1
|
Late Genetic Results Disclosure
n=20 Participants
Late disclosure group receives results of genetic testing at Month 12
Late disclosure of genetic testing results: Late disclosure group receives results of genetic testing at Month 12
|
|---|---|---|
|
Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure
Lutein + Zeaxanthin
|
238.3 nanograms per milliliter (ng/mL)
Standard Error 17.2
|
279.2 nanograms per milliliter (ng/mL)
Standard Error 29.9
|
|
Change in Serum Carotenoid Status in Response to Genetic Risk Disclosure
Total Carotenoids
|
618.0 nanograms per milliliter (ng/mL)
Standard Error 47.6
|
818.7 nanograms per milliliter (ng/mL)
Standard Error 82.7
|
Adverse Events
Early Genetic Results Disclosure
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Late Genetic Results Disclosure
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Early Genetic Results Disclosure
n=60 participants at risk
Early disclosure group receives results of genetic testing at Month 1
Early disclosure of genetic testing results: Early disclosure group receives results of genetic testing at Month 1
|
Late Genetic Results Disclosure
n=20 participants at risk
Late disclosure group receives results of genetic testing at Month 12
Late disclosure of genetic testing results: Late disclosure group receives results of genetic testing at Month 12
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ehlers-Danlos Syndrome hyper-mobility type
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Reproductive system and breast disorders
Endometriosis
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Blood and lymphatic system disorders
Splenic lesion
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Covid-19
|
3.3%
2/60 • Number of events 2 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Infections and infestations
Influenza A
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Metabolism and nutrition disorders
Elevated cholesterol
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/60 • 12 months
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
3.3%
2/60 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Endocrine disorders
Hyperglycemia
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Gout
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Endocrine disorders
Hypothyroidism
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Ptosis
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Vascular disorders
Hypertension
|
3.3%
2/60 • Number of events 2 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Neoplasms benign, malignant and unspecified
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Retinal hemorrhage
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritic rash
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Eye disorders
Cataract
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
|
Infections and infestations
Sinusitis
|
1.7%
1/60 • Number of events 1 • 12 months
|
0.00%
0/20 • 12 months
|
Additional Information
Paul Bernstein, Principal Investigator
University of Utah Moran Eye Center
Phone: 801-585-7231
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place