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

Kathryn Starr

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Intermediate Age-Related Macular Degeneration

Treatments: Drug: Whole Egg - 4; Drug: Whole Egg - 2

Study type: Interventional

Funder types: Other

Identifiers

NCT07021027

Pro00112553

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Whole Egg - 4

Experimental group

Description:

Participants will be asked to consume 4 medium eggs per day for five months.

Treatment:

Drug: Whole Egg - 4

Whole Egg - 2

Active Comparator group

Description:

Participants will be asked to consume 2 medium eggs per day for five months.

Treatment:

Drug: Whole Egg - 2