Progression of Early Atrophic Lesions
2 other identifiers
observational
125
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2023
CompletedFirst Posted
Study publicly available on registry
July 25, 2023
CompletedStudy Start
First participant enrolled
October 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 11, 2026
March 1, 2026
4.7 years
July 15, 2023
March 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in geographic atrophy (GA) lesion size
Total GA lesion size will be determined by applying the RegionFinder® software on fundus-autofluorescence (FAF) with the aid of near-infrared (NIR) and optical coherence tomography ( OCT) images for the decision for the actual presence of early atrophic lesions.
At months 36 from baseline
Study Arms (1)
Early GA lesions
Non-interventional
Interventions
Eligibility Criteria
Patients with early atrophic lesions secondary to AMD in at least one eye.
You may qualify if:
- 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 (RPE) and outer retinal atrophy (iRORA) (region of signal hypertransmission into the choroid, corresponding zone of attenuation or disruption of the RPE, and evidence of overlying photoreceptor degeneration that is, subsidence of the inner nuclear layer (INL) and outer plexiform layer (OPL), presence of a hyporeflective wedge in the Henle fiber layer (HFL), thinning of the outer nuclear layer (ONL), disruption of the external limiting membrane (ELM), or disintegrity of the ellipsoid zone (EZ), or
- complete RPE and outer retinal atrophy (cRORA) (homogeneous choroidal hypertransmission, absence of the RPE band measuring \> 250µm, evidence of overlying photoreceptor degeneration) and total lesions size =\< ½ disc area (DA) (corresponding to 1.27mm2 area) of all atrophic lesions measured on fundus-autofluorescence (FAF) imaging in the study eye.
- Sufficiently clear ocular media, adequate pupillary dilatation, and adequate fixation to permit quality fundus imaging and unbiased functional testing incl. fundus-controlled perimetry (FCP) testing.
- Ability to comply with study protocol timelines.
You may not qualify if:
- Signs or exudation defined as serous detachment of the sensory retina, intraretinal cystoid fluid, or subretinal/retinal hemorrhage in the study eye.
- cRORA lesion \>1/2 disc area in the study eye at baseline.
- History of central retinal laser treatment, including photodynamic therapy (PDT) and subthreshold laser treatment for AMD in the study eye.
- Cataract surgery in the study eye within the last three months prior to enrollment. Laser-capsulotomy in the study eye within the last 2 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 (\<3 months from termination of participation) in clinical trials investigating drugs or supplements in diseases other than AMD.
- Any concurrent ocular condition in the study eye (e.g. cataracts) that, in the opinion of the investigator, requires medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition or - if allowed to progress untreated - could likely contribute to loss of at least two Snellen equivalent lines of best-corrected visual acuity during the study period.
- Concomitant diseases that in the opinion of the investigator would make adherence to the examination schedule difficult or unlikely (e.g. personality disorder, chronic alcoholism, Alzheimer's Disease, drug abuse).
- Evidence of significantly uncontrolled concomitant diseases at the discretion of the investigator (e.g. cardiovascular, neurological, pulmonary, renal, hepatic, endocrine gastrointestinal disorder).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- National Eye Institute (NEI)collaborator
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monika Fleckenstein
University of Utah
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 15, 2023
First Posted
July 25, 2023
Study Start
October 20, 2023
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
March 11, 2026
Record last verified: 2026-03