RECRUITING

Eggs and Age-related Macular Degeneration (EggsAMD) Study.

Conditions

Intermediate Age-Related Macular Degeneration Older Adults Eggs vision

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility Study of Whole Egg Consumption in Adults With Intermediate Age-related Macular Degeneration

Quick Facts

Study Start:2025-06-18

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07021027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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)

Inclusion Criteria

Exclusion 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

* 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)

Contacts and Locations

Study Contact

Johanna Johnson, MS

CONTACT

919-479-2300

johanna.johnson@duke.edu

Principal Investigator

Kathryn N Starr, PhD, RDN

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University School of Medicine

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Kathryn Starr

Kathryn N Starr, PhD, RDN, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-18

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-06-18

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

Intermediate Age-Related Macular Degeneration
Older Adults
Eggs
vision

Additional Relevant MeSH Terms

Intermediate Age-Related Macular Degeneration