Actively Recruiting

Phase Not Applicable
Age: 50Years - 89Years
All Genders
Healthy Volunteers
ID06619405

AMD and Validating Rod-Mediated Dark Adaptation With Everyday Task Performance

Led by Duke University · Updated on 2025-08-21

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

B

Boehringer Ingelheim

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the relationship between rod-mediated dark adaptation and everyday task performance, such as reading under dim light, in older adults with early and intermediate age-related macular degeneration (AMD), including those with subretinal drusenoid deposits, as well as in individuals with normal eye health. The study involves a cross-sectional design conducted at two sites with a total of 200 participants classified by AMD severity using the AREDS system. This research aims to understand how AMD severity affects these visual functions important for daily activities. Participants are grouped based on their diagnosis: early AMD, intermediate AMD, geographic atrophy, or healthy controls. The study includes comprehensive eye exams and uses a virtual reality headset called Streetlab VR to simulate walking through a maze at various light levels. The main study assessments include measuring rod-mediated dark adaptation, reading ability with the MNREAD chart, mobility through the Mobility Standardized Test, and evaluation of ellipsoid zone loss in the retina. Individuals will attend a single study visit lasting approximately 5 to 6 hours, during which all visual and mobility tests will be performed. Researchers will collect detailed demographic information, ocular history, and medication use. Outcomes measured include the extent of ellipsoid zone attenuation and performance on dark adaptation, reading, and mobility tasks. The study will analyze correlations between these measures across participant groups. Total participation involves only this one-time visit, with safety and data monitored throughout the study period ending in 2027.

CONDITIONS

Brief Title

AMD and Validation Rod-Meditated Dark Adaptation With Everyday Task Performance

Who Can Participate

Age: 50Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Capable and willing to provide consent
  • Diagnosed with early, intermediate dry age-related macular degeneration, geographic atrophy, or has a healthy macula
  • At least 50 years old
Not Eligible

You will not qualify if you...

  • Unable or unwilling to give consent or unable to read consent
  • Under 50 years old
  • Dense cataracts in the study eye(s) affecting visual tests
  • Glaucoma requiring treatment or visual field defects
  • Previous retinal laser or surgical therapy in the study eye(s)
  • Any other ocular condition requiring long-term therapy or surgery during the study
  • Significant corneal or media opacities preventing adequate imaging and testing
  • Diagnosis of nystagmus interfering with testing
  • High myopia of -8 diopters or worse
  • Any physical or mental condition that increases risk or interferes with study procedures, as judged by the Investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single visit, approximately 5-6 hours

Participants undergo diagnostic tests including a comprehensive eye exam, rod-mediated dark adaptation testing, reading performance assessment, and mobility testing using the Streetlab VR headset to simulate walking through a maze at different light levels.

1 visit (in-person)

Long-term Monitoring

Duration - Approximately 2 years

Participants are observed for changes in ellipsoid zone band attenuation and disease progression over approximately 2 years.

Follow-up visits as scheduled by the study team

Trial Site Locations

Total: 1 location

1

Duke Eye Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

E

Eleonora Lad, MD, PhD

A

Alice Ventura

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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