Functionally Validated Structural Endpoints for Early AMD

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: t
View:

• For those in Normal Macular Health or Early AMD: aged ≥ 60 years; either have normal macular health in both eyes at baseline or have early AMD in one eye For Young Normals: aged 20-30 years old; normal macular health in both eyes.

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Time Frame
Start Date: 2019-10-07
Completion Date: 2024-10-31
Participants
Target number of participants: 556
Treatments
Normal Macular Health
\>=60 years old with no macular disease
Early Macular Degeneration
\>=60 years old with early age-related macular degeneration
Young Normals
20-30 years old with normal macular health
Sponsors
Leads: Cynthia Owsley

This content was sourced from clinicaltrials.gov