Streetlab VR for AMD

Overseen By Eleonora Lad, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Dense cataracts, Glaucoma, High myopia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well individuals with different stages of age-related macular degeneration (AMD) can read in dim light using a virtual reality tool called Streetlab VR. Researchers aim to determine if a connection exists between the eyes' adjustment to darkness and reading performance, focusing on the rod cells that assist with low-light vision. The study includes participants with early or intermediate AMD, geographic atrophy (a more advanced form of AMD), and healthy vision. Ideal candidates are at least 50 years old, can provide consent, and have not undergone previous eye surgeries or had conditions affecting vision tests. As an unphased trial, this study offers a unique opportunity to contribute to understanding AMD and its impact on vision.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that Streetlab VR is safe for use in this study?

In a previous study, researchers examined Streetlab VR and found that most patients tolerated it well. No serious side effects occurred. The study included individuals with age-related macular degeneration (AMD) and aimed to test both safety and effectiveness. Although a slight decrease in retinal sensitivity occurred over time, it was not linked to any harmful effects. Overall, the treatment has not shown any major safety concerns in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Streetlab VR is unique because it uses virtual reality technology to help people with Age-related Macular Degeneration (AMD) improve their daily visual experiences. Unlike standard treatments, which often involve medications or injections, this approach offers a non-invasive method to enhance visual function. Researchers are excited about this trial because it could provide a new way to support patients with varying stages of AMD, including early AMD, intermediate AMD, and geographic atrophy, potentially improving their quality of life without the need for medical or surgical interventions.

What evidence suggests that Streetlab VR is effective for AMD?

Research has shown that Streetlab VR, the investigational treatment in this trial, might assist people with age-related macular degeneration (AMD) by enhancing their ability to read in dim light. AMD affects the eyes and can lead to vision loss, making it difficult to see in low lighting. Streetlab VR uses virtual reality to enhance vision. Although limited data exists on its effectiveness, the concept is based on AMD's impact on the eye's rod cells, which aid in night vision. Early results suggest it might help users adapt to dark environments, potentially making everyday tasks like reading easier. ^{1 2 5 6 7}

Who Is on the Research Team?

Eleonora Lad, MD, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am able and willing to give my consent.

I am 50 years old or older.

I have early or intermediate dry age-related macular degeneration or geographic atrophy, or my macula is healthy.

Exclusion Criteria

I am under 50 years old.

I have dense cataracts in my eye(s) affecting my vision tests.

High myopia -8 Diopters or more severe

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Visit Assessment

Participants undergo a comprehensive eye exam, rod-mediated dark adaptation measurement, reading performance assessment, and mobility test

1 day

1 visit (in-person, approximately 5-6 hours)

Follow-up

Participants are monitored for changes in ellipsoid zone attenuation over time

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Streetlab VR

Trial Overview

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.

How Is the Trial Designed?

Group I: Intermediate AMD Experimental Treatment 1 Intervention

Study patients who have a diagnosis of Intermediate AMD

Group II: Geographic Atrophy Experimental Treatment 1 Intervention

Study patients who have a diagnosis of Geographic Atrophy

Group III: Early AMD Experimental Treatment 1 Intervention

Study patients who have a diagnosis of early AMD

Group IV: AMD Controls Experimental Treatment 1 Intervention

Study patients who have healthy eyes

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

StreetLab Vision

Industry Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

Only 2 out of 15 participants reported adverse drug reactions (ADRs) directly to the MedEffect system, with most opting to inform their physicians or pharmacists instead, highlighting a lack of awareness about the reporting system.

Barriers to reporting included physicians downplaying side effects, confusion about what to report, and a lack of feedback after submission, suggesting that simplifying the MedEffect reporting forms could improve patient engagement in ADR reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experiences on adverse drug reactions reporting: a qualitative study. Al Dweik, R., Yaya, S., Stacey, D., et al.[2021]

Current VR headsets have a minimum angular resolution of 0.41 logMAR on average, which is inadequate for reliable visual acuity testing and may not be suitable for treating conditions like amblyopia.

The average field of view for VR headsets is about 50.2°, which is significantly lower than manufacturer claims, but it may still be sufficient for certain visual field tests, although concerns exist for vergence testing due to varying eye-to-screen distances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring Virtual Reality Headset Resolution and Field of View: Implications for Vision Care Applications. Lynn, MH., Luo, G., Tomasi, M., et al.[2021]

In a survey of 459 members of the British Pharmacological Society, it was found that drugs were administered to 8163 healthy volunteers, with only 6.9% experiencing minor adverse effects and 0.04% facing potentially life-threatening effects, indicating a very low risk associated with these studies.

Among 7607 healthy student volunteers, only 6.0% reported minor adverse effects during drug administration for educational purposes, with no severe adverse effects noted, reinforcing the overall safety of drug administration in healthy volunteer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy volunteer studies in Great Britain: the results of a survey into 12 months activity in this field. Orme, M., Harry, J., Routledge, P., et al.[2019]

The base-in multiplexing prism (MxP) glasses significantly improved the ability of patients with acquired monocular vision (AMV) to detect pedestrians approaching from their blind side, providing a true field expansion of about 25°.

In a virtual reality walking environment, participants with simulated AMV showed better pedestrian detection rates when using the MxP, indicating that these glasses could help reduce collision risks for individuals with AMV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field Expansion with Multiplexing Prism Glasses Improves Pedestrian Detection for Acquired Monocular Vision. Jung, JH., Castle, R., Kurukuti, NM., et al.[2023]

The American Statistical Association's Interactive Safety Graphics Task Force has created a new interactive tool for analyzing drug safety data, specifically focusing on drug-induced liver damage, which enhances the review process.

This innovative tool, based on advancements in visual data processing and programming, serves as a prototype for developing additional interactive safety analysis tools, aiming to improve the evaluation of large safety datasets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Paradigm for Safety Data Signal Detection and Evaluation Using Open-Source Software Created by an Interdisciplinary Working Group. Buchanan, J., Li, M., Ni, X., et al.[2021]

Citations

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withpower.com

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Streetlab VR for AMD

This trial is for adults over 50 with early to intermediate dry age-related macular degeneration or geographic atrophy, and healthy individuals as controls.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5961066/

Report From the NEI/FDA Endpoints Workshop on Age ...

Microperimetry measurement of retinal sensitivity revealed an overall small mean loss after 1 year, albeit a statistically significant loss compared with ...

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researchgate.net

researchgate.net/publication/318384441_Report_From_the_NEIFDA_Endpoints_Workshop_on_Age-Related_Macular_Degeneration_and_Inherited_Retinal_Diseases

Report From the NEI/FDA Endpoints Workshop on Age ...

Vision loss of 15 or more letters was evaluated as a new endpoint in genetic analyses. Results: Eight common and rare variants in genes CFH, C3, ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06769048

NCT06769048 | A Study to Test Different Doses of BI ...

The purpose of this study is to find out whether a medicine called BI 1584862 improves the eyes in people with geographic atrophy and to find the most suitable ...

5.

aao.org

aao.org/education/editors-choice/real-world-data-suggest-high-disease-burden-progre

Real-World Data Suggest High Disease Burden and ...

A large database study found that most eyes with geographic atrophy lost significant visual acuity within 3 years of presentation, ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39149709/

Safety Results for Geographic Atrophy Associated with Age ...

The atrophic geographic areas tended to increase in both treated and fellow eyes at 12 months (P < 0.0001). No inflammatory reaction, ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04437368

NCT04437368 | EXPLORE: A Phase II Study to Evaluate ...

The purpose of this clinical study was to evaluate the safety and efficacy of two doses of GT005 administered as a single subretinal injection in subjects with ...