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Streetlab VR for AMD
N/A
Waitlist Available
Led By Eleonora Lad, MD, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with early, intermediate dry age-related macular degeneration or geographic atrophy, or has a healthy macula for controls
At least 50 years of age
Must not have
Under 50 years of age
Presence of dense cataracts in the study eye(s) that can affect visual function tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study older adults with a specific eye condition and compare their ability to see in the dark and read in low light to those with normal vision, to understand how well their eyes are functioning
Who is the study for?
This trial is for adults over 50 with early to intermediate dry age-related macular degeneration or geographic atrophy, and healthy individuals as controls. Participants must be able to consent and have no conditions like dense cataracts, severe myopia, nystagmus, glaucoma requiring treatment, or any condition that could affect the study's procedures.
What is being tested?
The study examines how well older adults with different stages of AMD can adapt to darkness and read in dim light using a virtual reality system called Streetlab VR. It aims to link dark adaptation (which relies on rod photoreceptors) with reading performance under low illumination.
What are the potential side effects?
Since this trial involves non-invasive testing using virtual reality technology rather than medication or surgery, there are minimal expected side effects. However, participants may experience discomfort from wearing VR headsets.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have early or intermediate dry age-related macular degeneration or geographic atrophy, or my macula is healthy.
Select...
I am 50 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 50 years old.
Select...
I have dense cataracts in my eye(s) affecting my vision tests.
Select...
I have an eye condition that needs long-term treatment or surgery.
Select...
I have nystagmus that affects my ability to undergo certain tests.
Select...
I have clear eyes that allow for detailed eye exams and tests.
Select...
I am being treated for glaucoma or have vision problems.
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I have had laser or surgery on my eye(s) before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total number of participants with total ellipsoid zone (EZ) band attenuation
Secondary study objectives
Mobility as measured by the Mobility Standardized Test (MOST)
Reading performance as measured by the MNREAD (Minnesota low vision reading) chart
Rod-mediated dark adaptation
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Intermediate AMDExperimental Treatment1 Intervention
Study patients who have a diagnosis of Intermediate AMD
Group II: Geographic AtrophyExperimental Treatment1 Intervention
Study patients who have a diagnosis of Geographic Atrophy
Group III: Early AMDExperimental Treatment1 Intervention
Study patients who have a diagnosis of early AMD
Group IV: AMD ControlsExperimental Treatment1 Intervention
Study patients who have healthy eyes
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Who is running the clinical trial?
Boehringer IngelheimIndustry Sponsor
2,551 Previous Clinical Trials
15,857,917 Total Patients Enrolled
StreetLab VisionIndustry Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,349 Total Patients Enrolled
Eleonora Lad, MD, PhDPrincipal InvestigatorDuke University
2 Previous Clinical Trials
188 Total Patients Enrolled