Feasibility Study of a Remote Behavioral Dietary Intervention in Patients With Early to Intermediate AMD: Glucose Lowering for Vision Extension

NCT07605468 | Not Yet Recruiting

• 2 other identifiers: 73980R34EY035782
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of the study is to test dietary intervention at glycemic control and carotenoid levels in participants with intermediate age-related macular degeneration.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Success rate of the diet behavioral modification

  Success rate of the behavioral modification of the diet based on self-reported assessments and in association with systemic markers of improved health due to dietary modifications. Continuous glucose monitoring measurements will be used to determine the proportion of time glucose \>140 mg/dL for 24 hr/day for two weeks at each visit. The definition of success will be halving the time glucose is \>140 mg/dL.

  baseline through one year

Study Arms (1)

low glycemic Mediterranean diet behavioral modification

EXPERIMENTAL

Participants receive recommendations to modify their diets to be low glycemic and adhere to Mediterranean diet Participants wear continuous glucose monitors for 2 weeks for one year.

Behavioral: Low glycemic Mediterranean diet behavioral modification

Interventions

Low glycemic Mediterranean diet behavioral modification BEHAVIORAL

Participants will meet with behavioral interventionists to receive guidance on diet initially for 2 hours and then every month for one hour

low glycemic Mediterranean diet behavioral modification

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of early to intermediate AMD with no history of retinal geographic atrophy (cRORA) or exudative disease
• Eating a diet less healthy than average (Healthy Eating Index \[HEI\] score \<61) based on 3 24-hour dietary recalls
• Access to a computer or smart phone for use in the behavioral meetings (we will provide loaners for those lacking a smart phone
• Because the initial questionnaires (ASA24), surveys and informed consent will be on line and in English, only individuals with fluency in English will be included. (They do not need to list English as their primary language.)

You may not qualify if:

• HbA1c greater than 6.5%,
• Diabetes or medications used to treat diabetes or obesity (including GLP1 agonists, metformin, glyburide
• Use of statins, niacin or other lipid/cholesterol modifying medications
• Recent cancer (within past 3 years)
• Other retinal or ocular pathology (other than pseudophakia and/or refractive error (between -8 to +8 diopter spherical equivalence)

Sponsors & Collaborators

• Stanford University: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Mary E Hartnett, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmology

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 5 years

Locations

US (1)