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NCT05959005Recruiting

Progression of Early Atrophic Lesions

Progression of Early Atrophic Lesions in Age-related Macular Degeneration (AMD).

Source: ClinicalTrials.gov · Last updated 11 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
125 (estimated)
First submitted
15 Jul 2023
Start date
20 Oct 2023
Primary completion date
30 Jun 2028
Lead sponsor
University of Utah
NCT number
NCT05959005

What you commit to

  • Study type: Observational
  • Planned participants: 125
  • From 20 Oct 2023 to the primary completion date, 30 Jun 2028
  • 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

  • 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.
  • 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).

Other illness

  • Signs or exudation defined as serous detachment of the sensory retina, intraretinal cystoid fluid, or subretinal/retinal hemorrhage in the study eye.
  • 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.
  • History of central retinal laser treatment, including photodynamic therapy (PDT) and subthreshold laser treatment for AMD in the study eye.

Other

  • cRORA lesion \>1/2 disc area in the study eye at baseline.

Who the study is looking for

  • 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.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.