Functionally Validated Structural Endpoints for Early AMD (NCT04112667) | Clinical Trial Compass
CompletedNot Applicable
Functionally Validated Structural Endpoints for Early AMD
United States556 participantsStarted 2019-10-07
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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.
Exclusion Criteria:
Exclusion for those in normal macular health are:
* ANY EYE CONDITION OR DISEASE IN EITHER EITHER (OTHER THAN EARLY CATARACT) THAT CAN IMPAIR VISION INCLUDING:
* diabetic retinopathy
* glaucoma
* ocular hypertension
* history of retinal diseases (e.g., retinal vein occlusion, retinal degenerations)
* optic neuritis
* corneal disease
* previous ocular trauma or surgery
* REFRACTIVE ERROR \>- 6 DIOPTERS
* NEUROLOGICAL CONDITIONS THAT CAN IMPAIR VISION OR JUDGEMENT INCLUDING:
* multiple sclerosis
* Parkinson disease
* stroke
* Alzheimer disease
* seizure disorders
* brain tumor
* traumatic brain injury
* PSYCHIATRIC DISORDERS THAT COULD IMPAIR THE ABILITY:
* to follow simple directions
* answer questions about health and functioning
* or to provide informed consent
* DIABETES
* ANY MEDICAL CONDITION THAT CAUSES SIGNIFICANT FRALITY OR IS BELIEVED TO BE TERMINAL.
Exclusion criteria for the early AMD group:
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:
* ANY EYE CONDITION OR DISEASE IN EITHER EYE (OTHER THAN EARLY CATARACT) THAT CAN IM…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rod-mediated dark adaptation
Timeframe: Measured at baseline enrollment
2
Rod-mediated dark adaptation
Timeframe: Measured at 3 years after baseline enrollment
3
incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging
Timeframe: Measured at baseline enrollment
4
incident age-related macular degeneration (AMD) or progression of AMD using multimodal imaging
Timeframe: Measured at 3 years after baseline enrollment