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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21EY033579 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Genetic Results Disclosure | Experimental | Early disclosure group receives results of genetic testing at Month 1 |
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| Late Genetic Results Disclosure | Active Comparator | Late disclosure group receives results of genetic testing at Month 12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early disclosure of genetic testing results | Behavioral | Early disclosure group receives results of genetic testing at Month 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | Baseline and Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Bernstein, MD, PhD | University of Utah Moran Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah John A. Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37337222 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Late Genetic Results Disclosure |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Error | Reflection units (RU) | Baseline and Month 12 |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ehlers-Danlos Syndrome hyper-mobility type | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Bernstein, Principal Investigator | University of Utah Moran Eye Center | 801-585-7231 | Paul.Bernstein@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 11, 2024 | Jul 25, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2023 | Jul 25, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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Participants will be masked to their AMD risk until their disclosure. Outcomes assessor and investigator will be masked to treatment assignment until completion of study.
| Late disclosure of genetic testing results | Behavioral | Late disclosure group receives results of genetic testing at 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). | Baseline and Month 12 |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Skin carotenoid status at baseline by RS | Reflectance Spectroscopy (RS) is measured by Veggie Meter and is presented in Reflection Units (RU). Possible scores range from 0 (no carotenoids detected) to greater than 500. | Mean | Standard Deviation | Reflection Units (RU) |
|
| Skin carotenoid status at baseline by RRS | Resonance Raman Spectroscopy (RSS) is presented in Resonance Raman Units (RRU). Possible scores range from 0 (no carotenoids detected) to greater than 100,000. | Mean | Standard Deviation | Resonance Raman Units (RRU) |
|
| Macular carotenoid status at baseline | 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. | Mean | Standard Deviation | unitless |
|
| Serum carotenoid status at baseline | Serum carotenoid levels are measured in nanograms per milliliter (ng/mL). Possible scores range from 0 (no carotenoids detected) to greater than 1,000. | Mean | Standard Deviation | nanograms per milliliter (ng/mL) |
|
|
|
| Primary | 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). | Posted | Mean | Standard Error | Resonance raman units (RRU) | Baseline and Month 12 |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Error | unitless | Baseline and Month 12 |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Error | nanograms per milliliter (ng/mL) | Baseline and Month 12 |
|
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|
| 0 |
| 60 |
| 0 |
| 60 |
| 18 |
| 60 |
| EG001 | 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 | 0 | 20 | 0 | 20 | 2 | 20 |
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
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| Splenic lesion | Blood and lymphatic system disorders | Systematic Assessment |
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| Covid-19 | Infections and infestations | Systematic Assessment |
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| Influenza A | Infections and infestations | Systematic Assessment |
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| Elevated cholesterol | Metabolism and nutrition disorders | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Hyperglycemia | Endocrine disorders | Systematic Assessment |
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| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Ptosis | Eye disorders | Systematic Assessment |
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| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Neoplasms benign, malignant and unspecified | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Retinal hemorrhage | Eye disorders | Systematic Assessment |
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| Pruritic rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | Systematic Assessment |
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| Cataract | Eye disorders | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
|
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