Eggs and age-related macular degeneration (EggsAMD)
Feasibility Study of Whole Egg Consumption in Adults With Intermediate Age-related Macular Degeneration
EARLY_PHASE1 · Duke University · NCT07021027
This pilot will try daily whole-egg consumption (2 or 4 eggs) for five months to see if it is feasible and to collect early data in adults 55+ with intermediate age-related macular degeneration.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07021027 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional pilot enrolls older adults with intermediate dry AMD and assigns participants to consume either two or four whole eggs per day for five months while following a study diet protocol. The primary aim is feasibility, including adherence and tolerability of the egg intervention, with secondary measures collected at intervals to describe changes and estimate effect sizes. Secondary outcomes include retinal sensitivity, vision measures, cognition, and physical function to provide preliminary outcome data for a larger trial. The study is conducted at Duke Center for Living and requires participants to have refrigeration and reliable transportation for study visits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55 or older with documented intermediate dry AMD, stable best-corrected visual acuity within 10 letters over the prior six months, BMI 22.0–39.9 kg/m2, willing to limit eggs before the study and follow the diet protocol, and able to store eggs and travel to study visits.
Not a fit: People with central geographic atrophy, active retinal fluid or hemorrhage, glaucoma, dense cataracts, prior retinal surgery that affected the retina, or other excluded retinal pathology are not eligible and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, a practical daily egg regimen could offer a simple dietary approach to support retinal sensitivity and related vision outcomes in people with intermediate AMD.
How similar studies have performed: Nutritional research has linked egg-derived nutrients like lutein and zeaxanthin to eye health, but whole-egg daily interventions for intermediate AMD are relatively novel with limited prior trial evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with intermediate dry AMD as noted in their medical record (defined as having multiple medium drusen, at least one large druse (\>125 μm or the approximate size of a vessel coming off the optic nerve), and/or non-center involving geographic atrophy) who are BCVA stable from prior exam within 6 months - defined by change of \< 10 letters on EDTRS chart (BCVA within 10 letters within past 6 months) * 55 years of age and older * Willing to limit consumption of eggs for one month prior to beginning the study intervention * Willing to follow diet protocol * Body Mass Index (22.0 - 39.9 kg/m2) * Access to refrigeration * Access to reliable transportation Exclusion Criteria: * Presence of retinal pathology such as central geographic atrophy, hemorrhage or retinal fluid and other macular pathology other than AMD * Presence of dense cataracts * Presence of glaucoma * Previous retinal laser or surgical therapy that has impacted the integrity of the retina * Any other ocular condition requiring long-term therapy or surgery during the study period * Participant has photographically significant corneal or media opacities in either eye that would preclude adequate ophthalmic imaging and functional testing * Diagnosis of nystagmus that will interfere with testing * Egg allergy * Uncontrolled hyperlipidemia (cholesterol \>240 mg/dL in the last 12 months, unless under active medication management to achieve \<240 mg/dL)
Where this trial is running
Durham, North Carolina
- Duke Center for Living — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Kathryn N Starr, PhD, RDN — Duke University
- Study coordinator: Johanna Johnson, MS
- Email: johanna.johnson@duke.edu
- Phone: 919-660-6766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intermediate Age-Related Macular Degeneration, Older Adults, Eggs, vision