Clinical trial NCT07021027: Eggs and Age-related Macular Degeneration (EggsAMD) Study.
Official title: Feasibility Study of Whole Egg Consumption in Adults With Intermediate Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Intermediate Age-Related Macular Degeneration
Keywords: Intermediate Age-Related Macular Degeneration
Older Adults
Eggs
vision
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Age-related macular degeneration (AMD) is the primary cause of vision loss in people over the age of 55. Currently, no cure is available for individuals suffering from AMD. The purpose of this pilot study is to evaluate the feasibility of implementing a 5-month egg intervention in adults with intermediate AMD. The objective of this research study is to evaluate the feasibility of a whole egg (2 or 4 per day) intervention in older adults with intermediate AMD. The secondary objective of this research is to determine descriptive statistics, change over time and estimate effect sizes for retinal sensitivity, and vision, cognition and physical function. By completing these research objectives, the researchers hope to gain preliminary evidence in support of a larger trial that will assess the impact of egg consumption on eye health in adults with AMD.


Eligibility criteria: Inclusion Criteria:

* Capable to provide consent
* 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)

Primary outcomes:
measure: Adherence rate to consuming four whole eggs per day
timeFrame: From intervention start to the end of treatment at 5 months.
Secondary outcomes:
measure: Vision function, as measured by percent reduced threshold (PRT)
timeFrame: Baseline and 5 months
measure: Vision function, as measured by Average threshold (AT)
timeFrame: Baseline and 5 months
measure: Vision function, as measured by Central macular thickness
timeFrame: Baseline and 5 months
measure: Vision function, as measured by Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline and 5 months
measure: Vision function, as measured by Low Luminance Visual Acuity (LL-BCVA)
timeFrame: Baseline and 5 months
measure: Vision function, as measured by Reading Acuity (MN Read)
timeFrame: Baseline and 5 months
measure: Vision function, as measured by Contrast Sensitivity
timeFrame: Baseline and 5 months
measure: Vision function, as measured by National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)
timeFrame: Baseline and 5 months
measure: Cognitive function, as measured by the Hopkins Verbal Learning Test
timeFrame: Baseline and 5 months
measure: Physical Function, as measured by balance
timeFrame: Baseline and 5 months
measure: Physical Function, as measured by 30-Second Chair Stand
timeFrame: Baseline and 5 months
measure: Physical Function, as measured by 30-Second Arm curl
timeFrame: Baseline and 5 months
measure: Physical Function, as measured by 8-foot up and go
timeFrame: Baseline and 5 months
measure: Quality of Life, as measured by the 36-Item Short Form Health Survey (SF-36)
timeFrame: Baseline and 5 months
measure: Dietary Intake
timeFrame: Baseline and 5 months
measure: Satisfaction with study participation
timeFrame: From enrollment to the end of treatment at 5 months
measure: Satisfaction with egg consumption (Whole Egg - 2)
timeFrame: From intervention start to the end of treatment at 5 months.
measure: Satisfaction with egg consumption (Whole Egg - 4)
timeFrame: From intervention start to the end of treatment at 5 months.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Kathryn N Starr, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
References: