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Age-Related Macular DegenerationNCT05959005

Progression of Early Atrophic Lesions

An observational study of Age-Related Macular Degeneration, run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
How many people
125 participants
Where
1 siteUnited States
Study dates
20 Oct 2023to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with early atrophic lesions secondary to AMD in at least one eye.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ray Nelson contact

801 585 1890

Ray.Nelson@hsc.utah.edu

Karen Daynes contact

Karen.Daynes@hsc.utah.edu

United States1 site, 1 recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Monika Fleckenstein, 4352146967, Monika.Fleckenstein@hsc.utah.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

The investigators will focus on a previously largely under-explored but highly relevant time window in progression of age-related macular degeneration (AMD), i.e., 'early atrophic AMD'. We postulate that a therapeutic effect in early atrophic AMD would probably save a large proportion of patients from progressive visual function loss and that it seems more justifiable to risk interventions in this time window than in earlier AMD stages. Against this background, a comprehensive knowledge of the natural disease progression in this potential therapeutic margin is essential. We will implement innovative multimodal high-resolution retinal imaging, comprehensive functional testing, and assessment of vision-related quality of life (VRQoL) combined with standardized and exploratory analysis strategies in a prospective, longitudinal study. This will enable the investigators to characterize and quantify the microstructural changes and associated functional and VRQoL deficits in eyes with early atrophic lesions with unprecedented accuracy. Knowledge of the strongest risk factors for accelerated disease progression will allow identification of patients at highest risk for visual function loss. Moreover, the investigator's hypothesis on disease-stage specific risk-factors may guide selection of therapeutic targets that are particularly susceptible in early atrophic AMD. Tailoring therapeutics to specific phenotypes and disease stages may be key to prevent irreversible vision loss and the associated reduced quality of life in patients with AMD.

Being tested
No intervention
Keywords
iRORA, cRORA, Geographic Atrophy, non-exudative
Medical subject headings
Macular Degeneration, Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    There is no intervention.

Study groups in NCT05959005
Study groupRoleWhat they receive
Early GA lesionsNon-interventional
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At months 36 from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2023
  2. Study start20 Oct 2023
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05959005
Sponsor's protocol ID
IRB_00143184
Other IDs
1R01EY034965-01
Status last verified
Mar 2026
First submitted
15 Jul 2023
Last updated
11 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Wei Y, Morobeid H, Daynes K, Lee S, Ansari G, Bredehorst J, Mireles J, Nelson R, Eakins RT, Brown T, Pfau M, Zhang Y, Schmitz-Valckenberg S, Fleckenstein M. Structure-function associations in eyes with Early Atrophic Age-related Macular Degeneration. Am J Ophthalmol. 2026 Sep 26:S0002-9394(26)00544-1. doi: 10.1016/j.ajo.2026.09.029. Online ahead of print.

    PubMed 42800655

Questions about this trial

What is this clinical trial studying?

An observational study of Age-Related Macular Degeneration, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ray Nelson (801 585 1890, Ray.Nelson@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in geographic atrophy (GA) lesion size (time frame: At months 36 from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05959005, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.

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