Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT05959005

Conditions

Age-Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

No intervention

Study Details

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.

Conditions

Age-Related Macular Degeneration

Study ID

NCT05959005

Start date

Oct 20, 2023

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Any history of treatment of exudative macular neovascularization (MNV) in the study eye (e.g. type 1, type 2, mixed, polypoidal choroidal vasculopathy, and retinal angiomatous proliferation); Note: Non-exudative type 1 MNV in the study eye is NOT an exclusion criterion; non-exudative or exudative MNV in the fellow eye is not an exclusion criterion. Fellow-eyes may receive treatment of exudative MNV as part of clinical care.
  • Any disease/disorder other than AMD in the study eye at the time of inclusion (e.g. monogenic retinal diseases, diabetic retinopathy, retinal detachment, previous retinal surgeries, myopic degeneration), uncontrolled glaucoma with intraocular pressure (IOP) of >30 mmHg (despite current pharmacological or non-pharmacological treatment) and uveitis.
  • 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).

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

Early GA lesions

Non-interventional

Interventions

No intervention

There is no intervention.

Primary outcome measure

  • Change in geographic atrophy (GA) lesion size [ Time Frame: At months 36 from baseline ]

Central Contacts and Locations

Central contacts

Ray Nelson

801 585 1890Ray.Nelson@hsc.utah.edu

Karen Daynes

Karen.Daynes@hsc.utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Contacts

Monika Fleckenstein

4352146967Monika.Fleckenstein@hsc.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • iRORA
  • cRORA
  • Geographic Atrophy
  • non-exudative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-03-11.