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

NCT06619405 | Recruiting FDA Device

• 1 other identifier: Pro00115500
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 photoreceptors.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 2 years

Secondary Outcomes (4)

• Total number of participants with partial ellipsoid zone (EZ) band attenuation

  Approximately 2 years

• Rod-mediated dark adaptation

  Single visit, approximately 5-6 hours

• Reading performance as measured by the MNREAD (Minnesota low vision reading) chart

  Single visit, approximately 5-6 hours

• Mobility as measured by the Mobility Standardized Test (MOST)

  Single visit, approximately 5-6 hours

Study Arms (4)

Early AMD

OTHER

Study patients who have a diagnosis of early AMD

Diagnostic Test: Streetlab VR

Intermediate AMD

OTHER

Study patients who have a diagnosis of Intermediate AMD

Diagnostic Test: Streetlab VR

Geographic Atrophy

OTHER

Study patients who have a diagnosis of Geographic Atrophy

Diagnostic Test: Streetlab VR

AMD Controls

OTHER

Study patients who have healthy eyes

Diagnostic Test: Streetlab VR

Interventions

Streetlab VR DIAGNOSTIC_TEST

Streetlab VR is a virtual reality headset that is warn to simulate walking through a maze at different light levels.

AMD Controls; Early AMD; Geographic Atrophy; Intermediate AMD

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Duke University: lead
• Boehringer Ingelheim: collaborator
• StreetLab Vision: collaborator

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Eleonora Lad, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleonora Lad, MD, PhD

CONTACT

919-684-4359; nora.lad@duke.edu

Alice Ventura

CONTACT

919-681-6585; alice.ventura@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 1, 2024
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)