NCT04112667Completed
Functionally Validated Structural Endpoints for Early AMD
Source: ClinicalTrials.gov · Last updated 26 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 556 (actual)
- First submitted
- 30 Sept 2019
- Start date
- 7 Oct 2019
- Primary completion date
- 1 Jul 2024
- Lead sponsor
- Cynthia Owsley
- Diseases
- Macular degeneration
- NCT number
- NCT04112667
What you commit to
- Study type: Observational
- Participants enrolled: 556
- From 7 Oct 2019 to the primary completion date, 1 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous ocular trauma or surgery
- previous ocular trauma or surgery
Other illness
- ANY EYE CONDITION OR DISEASE IN EITHER EITHER (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:
- ocular hypertension
- history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)
- corneal disease
- NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:
- Parkinson disease
- stroke
- Alzheimer disease
- seizure disorders
- PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY:
- DIABETES
- ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRALITY OR IS BELIEVED TO BE TERMINAL.
- ANY EYE CONDITION OR DISEASE IN EITHER EYE (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:
- ocular hypertension
- history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)
- optic neuritis, corneal disease
- NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:
- Parkinson disease
- stroke
- Alzheimer disease
- seizure disorders
- PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY TO:
- DIABETES
- ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRAILTY OR IS BELIEVED TO BE TERMINAL.
Other
- Exclusion for those in normal macular health are:
- diabetic retinopathy
- glaucoma
- optic neuritis
- REFRACTIVE ERROR \>- 6 DIOPTERS
- multiple sclerosis
- brain tumor
- traumatic brain injury
- to follow simple directions
- answer questions about health and functioning
- or to provide informed consent
- These are identical to those described above, except that it is acceptable for participants to have early AMD (AREDS 2-4) in one eye and be AREDS grade 1 or any stage of AMD in the fellow eye.
- Exclusion for Young Normals:
- diabetic retinopathy
- glaucoma
- RERACTIVE ERROR \>=6 DIOPTORS
- multiple sclerosis
- brain tumor
- traumatic brain injury
- follow simple directions
- answer questions about health and functioning
- or to provide informed consent
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
Related publications
- Impaired Rod-Mediated Vision is the Functional Hallmark of Ageing and Early and Intermediate Age-Related Macular Degeneration.Ophthalmic Physiol Opt · 2026 · PMID 42332292
This page is information, not medical advice. Discuss any trial with your doctor.