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Functionally Validated Structural Endpoints for Early AMD

NCT04112667 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 556

Last updated 2025-09-26

No results posted yet for this study

Summary

Delayed rod-mediated dark adaptation (RMDA), or delayed recovery of vision in a dark environment, is a functional biomarker (i.e., risk factor) for early age-related macular degeneration (AMD). This research plan is designed to elucidate the structural (anatomical) basis of this visual deficit using cellular- and subcellular level imaging of the retina and its supporting tissues in living people. An accurate map and timeline of structure-function relationships in persons tested for night vision will result in functionally validated structural endpoints for early AMD trials, as well as define major biologic effects for development into future treatments.

Conditions

  • Age-related Macular Degeneration
  • Aging

Interventions

OTHER

Normal Macular Health

This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.

OTHER

Early Macular Degeneration

This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.

OTHER

Young Normals

This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Cynthia Owsley

    lead OTHER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2024-07-01
Completion
2024-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04112667 on ClinicalTrials.gov