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The Moran AMD Genetic Testing Assessment Study
Phase 2 trial testing Early disclosure of genetic testing results in Age-Related Macular Degeneration in 80 participants. Completed in 12 July 2024.
| Lead sponsor | Paul S. Bernstein |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 3 August 2022 |
| Primary completion | 12 July 2024 |
| Estimated completion | 12 July 2024 |
| Sites | 1 location across United States |
Paul S. Bernstein — full company profile →
Adults 18 to 64, any sex, with Age-Related Macular Degeneration or Genetic Testing. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| Early Genetic Results Disclosure | 257.7 | ± 7.4 |
| Late Genetic Results Disclosure | 290.9 | ± 12.5 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Early Genetic Results Disclosure | 30,578.3 | ± 653.6 |
| Late Genetic Results Disclosure | 31,678.6 | ± 1,066.5 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Early Genetic Results Disclosure | 10,622.6 | ± 173.0 |
| Late Genetic Results Disclosure | 10,566.1 | ± 290.0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Early Genetic Results Disclosure | 238.3 | ± 17.2 |
| Late Genetic Results Disclosure | 279.2 | ± 29.9 |
| Group | Value | 95% CI |
|---|---|---|
| Early Genetic Results Disclosure | 618.0 | ± 47.6 |
| Late Genetic Results Disclosure | 818.7 | ± 82.7 |
Time frame: 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Early Genetic Results Disc… | Late Genetic Results Discl… |
|---|---|---|---|
| Covid-19 | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Hypertension | Vascular disorders | — | — |
| Ehlers-Danlos Syndrome hyper-mobility type | Musculoskeletal and connective tissue disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Endometriosis | Reproductive system and breast disorders | — | — |
| Splenic lesion | Blood and lymphatic system disorders | — | — |
| Influenza A | Infections and infestations | — | — |
| Elevated cholesterol | Metabolism and nutrition disorders | — | — |
| Arthritis | Musculoskeletal and connective tissue disorders | — | — |
| Hyperglycemia | Endocrine disorders | — | — |
| Gout | Musculoskeletal and connective tissue disorders | — | — |
| Hypothyroidism | Endocrine disorders | — | — |
| Ptosis | Eye disorders | — | — |
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Neoplasms benign, malignant and unspecified | Skin and subcutaneous tissue disorders | — | — |
| Retinal hemorrhage | Eye disorders | — | — |
| Pruritic rash | Skin and subcutaneous tissue disorders | — | — |
| Inguinal hernia | Gastrointestinal disorders | — | — |
| Cataract | Eye disorders | — | — |
| Sinusitis | Infections and infestations | — | — |
Data from ClinicalTrials.gov NCT05265624 adverse events section.
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.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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