Age-Related Macular DegenerationNCT06619405
AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance
A study testing Streetlab VR in people with Age-Related Macular Degeneration, run by Duke University at 1 site in United States.
Trial summary
The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod… Read more about this study
- Who is it for?
- Ages 50 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Streetlab VR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 31 Jan 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 50 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capable and willing to provide consent
- Has been diagnosed with early, intermediate dry age-related macular degeneration or geographic atrophy or has a healthy macular for controls
- At least 50 years of age
Who cannot join
- Unable or unwilling to give consent or unable to read consent since the study involves testing which requires reading
- Under 50 years of age
- Presence of dense cataracts in the study eye (s) that can affect visual function tests
- Presence of glaucoma requiring treatment during the study and/or visual field defects
- Previous retinal laser or surgical therapy in the study eye(s)
- Previous retinal laser or surgical therapy in the study eye(s)
Show all 11Show fewer
- Any other ocular condition requiring long-term therapy or surgery during the study
- The 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
- High myopia -8 Diopters or more severe
- The participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.
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, 1 recruiting
- Recruiting
Duke Eye Center
Durham, North Carolina, 27710
About this study
Official title: AMD and Validating Rod-Meditated Dark Adaptation With Everyday Task Performance
The goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.
Read the detailed description
The investigators propose two sites for the study, Duke University and UAB. Each site will enroll 100 participants as indicated in the table above, per the AREDS 9-step AMD classification system, with 200 participants in the sample. Because the variance of rod-mediated dark adaptation in AMD patients increases with increasing disease severity, the investigators will implement a larger sample size for intermediate AMD and a smaller sample for patients in normal macular health.
The investigators will collect demographic characteristics (age, race/ethnicity, gender), ocular medical history from the electronic health record, and medication use. In addition, the protocol will focus on measuring the following major components:
- Comprehensive eye exam
- Rod-mediated dark adaptation
- Reading performance
- Mobility
- Ellipsoid zone loss and attenuation
Statistical associations will be computed using correlational analysis for the overall sample, within each patient group, and also separately for those with SDD. Sample size estimation is challenging because there is no previous literature on the association between rod-mediated dark adaptation and MNREAD reading performance or MOST performance. With a sample size of 200 participants, the investigators will have adequate statistical power (80%) to detect a correlation of at least 0.20 for the total sample and adequate statistical power to detect within-group correlations of at least 0.40.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Streetlab VR
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streetlab VRDiagnostic test
Streetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels.
| Study group | Role | What they receive |
|---|---|---|
| Early AMD | Other | Study patients who have a diagnosis of early AMD Receives: Diagnostic Test: Streetlab VR |
| Intermediate AMD | Other | Study patients who have a diagnosis of Intermediate AMD Receives: Diagnostic Test: Streetlab VR |
| Geographic Atrophy | Other | Study patients who have a diagnosis of Geographic Atrophy Receives: Diagnostic Test: Streetlab VR |
| AMD Controls | Other | Study patients who have healthy eyes Receives: Diagnostic Test: Streetlab VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of participants with total ellipsoid zone (EZ) band attenuation
Total EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness = 0 μm.
Measured: Approximately 2 years
Secondary outcomes (4)
Total number of participants with partial ellipsoid zone (EZ) band attenuation
Partial EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness ≤ 20 μm.
Measured: Approximately 2 years
Rod-mediated dark adaptation
Measured for right and left eyes separately using the AdaptDx, a computerized dark adaptometer.
Measured: Single visit, approximately 5-6 hours
Reading performance as measured by the MNREAD (Minnesota low vision reading) chart
Reading performance will be assessed binocularly with the MNREAD iPad app on a digital version of the MNREAD chart. The MNREAD is a text based chart used to measure near visual acuity in people with normal or low vision.
Measured: Single visit, approximately 5-6 hours
Mobility as measured by the Mobility Standardized Test (MOST)
The MOST task involves walking through a maze which can be performed under a range of mesopic and photopic conditions. Scoring is automatically computed based on the duration and mobility errors, which generated a score from 0 to 100, with 100 as the best performance.
Measured: Single visit, approximately 5-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start15 Aug 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 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 Duke 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, StreetLab Vision
- Responsible party
- Sponsor
- Investigators
- Eleonora Lad, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619405
- Sponsor's protocol ID
- Pro00115500
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2024
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMD and Validating Rod-Meditated Dark Adaptation With Everyday Task Performance
- ClinicalTrials.gov ID
- NCT06619405
- Acronym / sponsor ID
- Pro00115500
- Conditions
- Age-Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, StreetLab Vision
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 1 Oct 2024 (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 goal is to conduct a cross-sectional, single timepoint study on older adults with early and intermediate AMD, and with subretinal drusenoid deposits (SDD), and those in normal health, establishing an association between dark adaptation and reading performance under dim illumination, both which depend on rod photoreceptors.
Detailed description
The investigators propose two sites for the study, Duke University and UAB. Each site will enroll 100 participants as indicated in the table above, per the AREDS 9-step AMD classification system, with 200 participants in the sample. Because the variance of rod-mediated dark adaptation in AMD patients increases with increasing disease severity, the investigators will implement a larger sample size for intermediate AMD and a smaller sample for patients in normal macular health.
The investigators will collect demographic characteristics (age, race/ethnicity, gender), ocular medical history from the electronic health record, and medication use. In addition, the protocol will focus on measuring the following major components:
- Comprehensive eye exam
- Rod-mediated dark adaptation
- Reading performance
- Mobility
- Ellipsoid zone loss and attenuation
Statistical associations will be computed using correlational analysis for the overall sample, within each patient group, and also separately for those with SDD. Sample size estimation is challenging because there is no previous literature on the association between rod-mediated dark adaptation and MNREAD reading performance or MOST performance. With a sample size of 200 participants, the investigators will have adequate statistical power (80%) to detect a correlation of at least 0.20 for the total sample and adequate statistical power to detect within-group correlations of at least 0.40.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early AMD | Other | Diagnostic Test: Streetlab VRStudy patients who have a diagnosis of early AMD |
| Intermediate AMD | Other | Diagnostic Test: Streetlab VRStudy patients who have a diagnosis of Intermediate AMD |
| Geographic Atrophy | Other | Diagnostic Test: Streetlab VRStudy patients who have a diagnosis of Geographic Atrophy |
| AMD Controls | Other | Diagnostic Test: Streetlab VRStudy patients who have healthy eyes |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Capable and willing to provide consent
- Has been diagnosed with early, intermediate dry age-related macular degeneration or geographic atrophy or has a healthy macular for controls
- At least 50 years of age
Key exclusion criteria (11 listed)
- Unable or unwilling to give consent or unable to read consent since the study involves testing which requires reading
- Under 50 years of age
- Presence of dense cataracts in the study eye (s) that can affect visual function tests
- Presence of glaucoma requiring treatment during the study and/or visual field defects
- Previous retinal laser or surgical therapy in the study eye(s)
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 |
|---|---|---|
| Streetlab VRStreetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels. | Diagnostic test | AMD Controls, Early AMD, Geographic Atrophy, Intermediate AMD |
Primary outcome
Total number of participants with total ellipsoid zone (EZ) band attenuation
Time frame: Approximately 2 years
Total EZ attenuation is defined as EZ-RPE (retinal pigment epithelium) thickness = 0 μm.
4 secondary outcomes
Total number of participants with partial ellipsoid zone (EZ) band attenuation
Time frame: Approximately 2 years
Rod-mediated dark adaptation
Time frame: Single visit, approximately 5-6 hours
Reading performance as measured by the MNREAD (Minnesota low vision reading) chart
Time frame: Single visit, approximately 5-6 hours
Mobility as measured by the Mobility Standardized Test (MOST)
Time frame: Single visit, approximately 5-6 hours
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 10 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Age-Related Macular Degeneration
Active, not recruitingPhase 4
A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration
Geographic Atrophy, Age-Related Macular Degeneration
RecruitingObservational study
Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)
Age-Related Macular Degeneration
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
Not yet recruiting
Remapping Text in Sentence and Word Tasks to Aid Reading With Central Vision Loss
Macular Degeneration, Central Visual Impairment
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.
Eleonora Lad, MD, PhD 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 study testing Streetlab VR in people with Age-Related Macular Degeneration, run by Duke 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Aug 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?
Contact Eleonora Lad, MD, PhD (919-684-4359, nora.lad@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of participants with total ellipsoid zone (EZ) band attenuation (time frame: Approximately 2 years). 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 10 Aug 2026.