Actively Recruiting
Progression of Early Atrophic Lesions
Led by University of Utah · Updated on 2026-03-11
125
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
Sponsors
U
University of Utah
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Early atrophic age-related macular degeneration (AMD) represents an important time window in the course of so far untreatable atrophic AMD, as patients typically experience only some degree of visual dysfunction, while being at significant risk for marked further loss of vision. To allow the precise evaluation of upcoming therapeutic interventions, a better understanding of the manifestation and variable disease progression is needed. This project aims to investigate refined tools to detect and monitor early atrophic AMD more accurately, including the impact on visual dysfunction and quality of life.
CONDITIONS
Official Title
Progression of Early Atrophic Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 50 years and older of all ethnicities
- Study eye with at least one early atrophic lesion defined as incomplete retinal pigment epithelium and outer retinal atrophy (iRORA) or complete retinal pigment epithelium and outer retinal atrophy (cRORA) with total lesion size equal or less than half disc area measured by fundus-autofluorescence imaging
- Sufficiently clear ocular media, adequate pupillary dilatation, and adequate fixation to allow quality fundus imaging and unbiased functional testing including fundus-controlled perimetry
- Ability to comply with study protocol timelines
You will not qualify if you...
- Signs of or presence of serous detachment of the sensory retina, intraretinal cystoid fluid, or subretinal/retinal hemorrhage in the study eye
- cRORA lesion greater than half disc area in the study eye at baseline
- History of treatment for exudative macular neovascularization in the study eye
- Any other eye disease or disorder in the study eye at the time of inclusion such as monogenic retinal diseases, diabetic retinopathy, retinal detachment, previous retinal surgeries, myopic degeneration, uncontrolled glaucoma with intraocular pressure over 30 mmHg, or uveitis
- History of central retinal laser treatment including photodynamic therapy and subthreshold laser treatment in the study eye
- Cataract surgery in the study eye within the last three months prior to enrollment or laser-capsulotomy within the last two weeks prior to enrollment
- Current or previous participation in clinical trials investigating drugs or supplements in AMD except vitamins and minerals
- Current or previous participation within the last three months in clinical trials investigating drugs or supplements for diseases other than AMD
- Any other ocular condition in the study eye requiring medical or surgical intervention during the study period to prevent visual loss or likely to cause loss of at least two Snellen equivalent lines of best-corrected visual acuity
- Concomitant diseases that would make adherence to the examination schedule difficult or unlikely, including personality disorders, chronic alcoholism, Alzheimer's disease, or drug abuse
- Evidence of significantly uncontrolled concomitant diseases such as cardiovascular, neurological, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Utah
Salt Lake City, Utah, United States, 84132
Actively Recruiting
Research Team
R
Ray Nelson
CONTACT
K
Karen Daynes
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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