Age-Related Macular DegenerationGLOVENCT07605468
Feasibility Study of a Remote Behavioral Dietary Intervention in Patients With Early to Intermediate AMD: Glucose Lowering for Vision Extension
A study testing Low glycemic Mediterranean diet behavioral modification in people with Age-Related Macular Degeneration, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Low glycemic Mediterranean diet behavioral modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2028
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Nonrandomized, Unmasked Feasibility Study of a Remote-based Behavioral Dietary Intervention in Patients With Early to Intermediate AMD: Glucose Lowering for Vision Extension (GLOVE)
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
- Being tested
- Low glycemic Mediterranean diet behavioral modification
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic Mediterranean diet behavioral modificationBehavioural
Participants will meet with behavioral interventionists to receive guidance on diet initially for 2 hours and then every month for one hour
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Low glycemic Mediterranean diet behavioral modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline through one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Mary Elizabeth Hartnett, Stanford University
- Investigators
- Mary E Hartnett, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605468
- Sponsor's protocol ID
- 73980
- Other IDs
- R34EY035782
- Acronym
- GLOVE
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data will be shared among UCLA, Dartmouth, Tufts and Stanford
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nonrandomized, Unmasked Feasibility Study of a Remote-based Behavioral Dietary Intervention in Patients With Early to Intermediate AMD: Glucose Lowering for Vision Extension (GLOVE)
- ClinicalTrials.gov ID
- NCT07605468
- Acronym / sponsor ID
- GLOVE / 73980
- Conditions
- Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 May 2026 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| low glycemic Mediterranean diet behavioral modification | Experimental | Behavioral: Low glycemic Mediterranean diet behavioral modificationParticipants 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. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| Low glycemic Mediterranean diet behavioral modificationParticipants will meet with behavioral interventionists to receive guidance on diet initially for 2 hours and then every month for one hour | Behavioural | low glycemic Mediterranean diet behavioral modification |
Primary outcome
Success rate of the diet behavioral modification
Time frame: baseline through one year
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.
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 26 May 2026.
- Individual participant dataSharing planned: Yes. data will be shared among UCLA, Dartmouth, Tufts and Stanford
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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.
Mary E Hartnett, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic Mediterranean diet behavioral modification in people with Age-Related Macular Degeneration, run by Stanford University 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 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.
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?
Success rate of the diet behavioral modification (time frame: baseline through one year). 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 26 May 2026.