Intermediate Age-Related Macular DegenerationEarly Phase 1EggsAMDNCT07021027
Eggs and Age-related Macular Degeneration (EggsAMD) Study.
A Early Phase 1 study testing Whole Egg - 4 and Whole Egg - 2 in people with Intermediate Age-Related Macular Degeneration, run by Kathryn Starr at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Intermediate Age-Related Macular Degeneration
- What is being tested?
- Whole Egg - 4 and Whole Egg - 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 31 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Living
Durham, North Carolina, 27705
About this study
Official title: Feasibility Study of Whole Egg Consumption in Adults With Intermediate Age-related Macular Degeneration
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.
- Being tested
- Whole Egg - 4, Whole Egg - 2
- Keywords
- Intermediate Age-Related Macular Degeneration, Older Adults, Eggs, vision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Egg - 4Drug
Participants will be asked to consume 4 medium Eggland's Best eggs per day for 5 months.
Whole Egg - 2Drug
Participants will be asked to consume 2 medium Eggland's Best eggs per day for 5 months.
| Study group | Role | What they receive |
|---|---|---|
| Whole Egg - 4 | Experimental | Participants will be asked to consume 4 medium eggs per day for five months. Receives: Drug: Whole Egg - 4 |
| Whole Egg - 2 | Active comparator | Participants will be asked to consume 2 medium eggs per day for five months. Receives: Drug: Whole Egg - 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate to consuming four whole eggs per day
Adherence Rate (%) = (Number of days with 4 whole eggs consumed / Total number of days in the observation period) x 100
Measured: From intervention start to the end of treatment at 5 months.
Secondary outcomes (18)
Vision function, as measured by percent reduced threshold (PRT)
Mesopic microperimetry with eye tracking (MAIA) results will be reported as percent reduced threshold (PRT), defined as the percentage of abnormal retinal sensitivity thresholds below 25 dB.
Measured: Baseline and 5 months
Vision function, as measured by Average threshold (AT)
Mesopic microperimetry with eye tracking (MAIA) results will be reported as average threshold (AT), defined as the average of retinal sensitivity values from all loci tested.
Measured: Baseline and 5 months
Vision function, as measured by Central macular thickness
Central macular thickness will be measured by Optical Coherence Tomography (OCT)
Measured: Baseline and 5 months
Vision function, as measured by Best Corrected Visual Acuity (BCVA)
BCVA will be assessed by reading a standard eye chart placed at a distance
Measured: Baseline and 5 months
Vision function, as measured by Low Luminance Visual Acuity (LL-BCVA)
LL-BCVA will be assessed by reading a standard eye chart placed at a distance in low-light conditions
Measured: Baseline and 5 months
Vision function, as measured by Reading Acuity (MN Read)
Participants will be asked to read a chart with various print sizes (MNREAD acuity charts)
Measured: Baseline and 5 months
Vision function, as measured by Contrast Sensitivity
Participants will be asked to read letters (which will be colored in a range of gray) on an eye chart or iPad, placed at a distance.
Measured: Baseline and 5 months
Vision function, as measured by National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)
Participants will rate their vision on multiple activities of daily living based on their own opinion. The NEI VFQ-25 is scored by converting item responses to a 0-100 scale, averaging them into subscales, and calculating a composite score (excluding general health), with higher scores indicating better visual function.
Measured: Baseline and 5 months
Cognitive function, as measured by the Hopkins Verbal Learning Test
The Hopkins Verbal Learning Test is scored by summing the number of correct words recalled across three learning trials (Total Recall), the number recalled after a delay (Delayed Recall), and the number of correctly identified words on a recognition task (Recognition Discrimination Index), with higher scores indicating better verbal learning and memory performance.
Measured: Baseline and 5 months
Physical Function, as measured by balance
Will be asked to stand for 10 seconds with feet in 3 different positions (side-by-side, semi-tandem, tandem). The balance component of the SPPB is scored from 0 to 4 based on the ability to hold side-by-side, semi-tandem, and tandem stances for up to 10 seconds each, with higher scores indicating better balance.
Measured: Baseline and 5 months
Physical Function, as measured by 30-Second Chair Stand
Number of full stands that can be completed in 30 seconds with arms folded across chest
Measured: Baseline and 5 months
Physical Function, as measured by 30-Second Arm curl
Number of arm curls completed in 30 seconds.
Measured: Baseline and 5 months
Physical Function, as measured by 8-foot up and go
Number of seconds required to get up from a seated position, walk 8 feet (2.44 m), turn, and return to seated position
Measured: Baseline and 5 months
Quality of Life, as measured by the 36-Item Short Form Health Survey (SF-36)
Measured: Baseline and 5 months
Dietary Intake
3-day food record and recalls. Total calories (kcals) consumed are determined by averaging the intake of three days. A higher mean number indicates that more calories are consumed.
Measured: Baseline and 5 months
Satisfaction with study participation
On a 1-5 Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied), overall, how satisfied are you with your decision to participate in this study?
Measured: From enrollment to the end of treatment at 5 months
Satisfaction with egg consumption (Whole Egg - 2)
On a 1-5 Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied), How satisfied were you with consuming two medium eggs per day for the duration of the study?
Measured: From intervention start to the end of treatment at 5 months.
Satisfaction with egg consumption (Whole Egg - 4)
On a 1-5 Likert scale (1 = Very Dissatisfied, 5 = Very Satisfied), how satisfied were you with consuming four medium eggs per day for the duration of the study?
Measured: From intervention start to the end of treatment at 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start18 Jun 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathryn Starr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathryn Starr, Duke University
- Investigators
- Kathryn N Starr, PhD, RDN, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021027
- Sponsor's protocol ID
- Pro00112553
- Acronym
- EggsAMD
- Status last verified
- Apr 2026
- First submitted
- 5 Jun 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Whole Egg Consumption in Adults With Intermediate Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07021027
- Acronym / sponsor ID
- EggsAMD / Pro00112553
- Keywords
- Intermediate Age-Related Macular Degeneration, Older Adults, Eggs, vision
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kathryn StarrUniversity, hospital or other
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Egg - 4 | Experimental | Drug: Whole Egg - 4Participants will be asked to consume 4 medium eggs per day for five months. |
| Whole Egg - 2 | Active comparator | Drug: Whole Egg - 2Participants will be asked to consume 2 medium eggs per day for five months. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Egg - 4Participants will be asked to consume 4 medium Eggland's Best eggs per day for 5 months. | Drug | Whole Egg - 4 |
| Whole Egg - 2Participants will be asked to consume 2 medium Eggland's Best eggs per day for 5 months. | Drug | Whole Egg - 2 |
Primary outcome
Adherence rate to consuming four whole eggs per day
Time frame: From intervention start to the end of treatment at 5 months.
Adherence Rate (%) = (Number of days with 4 whole eggs consumed / Total number of days in the observation period) x 100
18 secondary outcomes
Vision function, as measured by percent reduced threshold (PRT)
Time frame: Baseline and 5 months
Vision function, as measured by Average threshold (AT)
Time frame: Baseline and 5 months
Vision function, as measured by Central macular thickness
Time frame: Baseline and 5 months
Vision function, as measured by Best Corrected Visual Acuity (BCVA)
Time frame: Baseline and 5 months
Vision function, as measured by Low Luminance Visual Acuity (LL-BCVA)
Time frame: Baseline and 5 months
Vision function, as measured by Reading Acuity (MN Read)
Time frame: Baseline and 5 months
Vision function, as measured by Contrast Sensitivity
Time frame: Baseline and 5 months
Vision function, as measured by National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25)
Time frame: Baseline and 5 months
Cognitive function, as measured by the Hopkins Verbal Learning Test
Time frame: Baseline and 5 months
Physical Function, as measured by balance
Time frame: Baseline and 5 months
Physical Function, as measured by 30-Second Chair Stand
Time frame: Baseline and 5 months
Physical Function, as measured by 30-Second Arm curl
Time frame: Baseline and 5 months
Physical Function, as measured by 8-foot up and go
Time frame: Baseline and 5 months
Quality of Life, as measured by the 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline and 5 months
Dietary Intake
Time frame: Baseline and 5 months
Satisfaction with study participation
Time frame: From enrollment to the end of treatment at 5 months
Satisfaction with egg consumption (Whole Egg - 2)
Time frame: From intervention start to the end of treatment at 5 months.
Satisfaction with egg consumption (Whole Egg - 4)
Time frame: From intervention start to the end of treatment at 5 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn N Starr, PhD, RDN principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Whole Egg - 4 and Whole Egg - 2 in people with Intermediate Age-Related Macular Degeneration, run by Kathryn Starr at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence rate to consuming four whole eggs per day (time frame: From intervention start to the end of treatment at 5 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.