Visual Remapping for Age-Related Macular Degeneration

Overseen By Gordon Legge, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Unilateral scotomas, Poor fixation, others

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

Compensation: Varies

Number of Visits: 9

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help individuals with age-related macular degeneration, a common eye condition that causes central vision loss, improve their reading ability. It tests different techniques of "remapping," which shift the missing text in a person's vision to areas they can see more clearly. Participants may receive either personalized remapping, a tailored approach, or traditional remapping strategies. Individuals with central vision loss affecting daily activities and who can maintain steady eye focus might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance daily life for those facing vision challenges.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these remapping techniques are safe for patients with central vision loss?

Research has shown that treatments for age-related macular degeneration (AMD) are generally safe. Studies have used artificial intelligence (AI) to predict and manage AMD for personalized treatments. Although these studies do not specifically focus on safety, AI can tailor treatments to each person, often enhancing safety.

For traditional treatments, research primarily examines their effectiveness and their relation to AMD severity. These studies do not specifically mention serious side effects, suggesting that traditional treatments are well-tolerated.

Overall, both personalized and traditional treatments have not raised major safety concerns in the available studies. This suggests they are likely safe options for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the visual remapping techniques for age-related macular degeneration (AMD) because they offer a new way to help patients adapt to vision loss. Traditional treatments like anti-VEGF injections target the disease's progression, but remapping focuses on retraining the brain to use the remaining healthy parts of the retina. Personalized remapping tailors this process to each individual's unique vision changes, potentially leading to better visual function. This approach could complement existing therapies, providing a holistic strategy to improve quality of life for those with AMD.

What evidence suggests that this trial's remapping techniques could be effective for age-related macular degeneration?

This trial will compare personalized remapping with traditional remapping for individuals with age-related macular degeneration (AMD). Research has shown that personalized treatment plans could benefit people with AMD by addressing their specific needs. Artificial intelligence shows promise in predicting AMD progression, potentially leading to better personalized care. Conversely, traditional methods have evidence supporting the brain's ability to adapt in people with central vision loss. Studies have found that the brain can reorganize how it processes visual information, aiding patients in adjusting to changes in their vision. Both methods aim to help people with AMD improve their reading and sight, offering hope for better vision management. ^{1 2 3 6 7}

Who Is on the Research Team?

Stephen Engel, Ph.D.

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for individuals aged 16 or older with central vision loss from age-related macular degeneration. Participants must have a stable gaze within one degree using their preferred retinal locus (PRL) and be able to calibrate an eye tracker. Those with cognitive impairment, poor fixation, or insufficient central vision loss are excluded.

Inclusion Criteria

You are able to use an eye tracker accurately.

No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).

I can keep my gaze steady using my preferred retinal location.

Exclusion Criteria

It is not possible to properly calibrate the eye tracker for accurate measurements.

I have central vision loss but can still see directly in front of me.

Poor fixation (worse than+/- 1 deg) using their PRL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Initial Assessment and Calibration

Participants undergo visual field loss characterization, scotoma mapping, and eye tracker calibration

1 week

1 visit (in-person)

Personalized Remapping and Reading Tasks

Participants perform visual tasks and reading tasks with and without remapping over multiple sessions

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for any changes in reading performance and eye movement quality

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Remapping
• Traditional Remapping

Trial Overview The study measures reading performance in patients with Central Vision Loss. It compares the effectiveness of traditional remapping versus personalized remapping of text to different visual fields in aiding reading.

How Is the Trial Designed?

Group I: Patients with scotoma Experimental Treatment 2 Interventions

No remapping (control condition), traditional remapping, personalized remapping

Group II: Normally sighted with artificial scotoma Active Control 2 Interventions

No remapping (control condition), traditional remapping, personalized remapping

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8590159/

Personalized Atrophy Risk Mapping in Age-Related Macular ... We developed a machine learning method for RORA progression prediction, which provides continuous-time output. It was used to compute atrophy risk maps.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666914524001015

Artificial Intelligence-Based Disease Activity Monitoring to ... Purpose. To evaluate the performance of a disease activity (DA) model developed to detect DA in participants with neovascular age-related macular degeneration ( ...

3. ophthalmologytimes.com ophthalmologytimes.com/view/ai-models-offer-hope-for-personalized-amd-treatment-plans

AI models offer hope for personalized AMD treatment plans A team of Korean researchers developed an AI model using OCT images to predict neovascular AMD treatment outcomes after anti-VEGF injections.

4. nature.com nature.com/articles/s41433-022-02154-8

Personalized treatment supported by automated ... Treat-and-extend versus monthly regimen in neovascular age-related macular degeneration: results with ranibizumab from the TREND study.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5954014/

Exploring the Use of Molecular Biomarkers for Precision ... In this review, we provide an overview of the studies that have evaluated the use of molecular biomarkers to predict response to treatment in AMD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3405316/

Predictive, preventive and personalised medicine for age ... Age-related macular degeneration (AMD) is an ophthalmologic disease which usually affects older adults and represents the leading cause of legal blindness ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07216924

Remapping Text in Sentence and Word Tasks to Aid ... Exclusion Criteria: Neovascular AMD; Any history of visual disorders other than that causing the central vision loss. Ages Eligible for Study.