Investigating early atrophic age-related macular degeneration

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

This study is trying to learn more about early atrophic age-related macular degeneration to see how it affects vision and what might help prevent further vision loss for people experiencing this condition.

Quick facts

• Study type: Observational
• Enrollment: 125 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: University of Utah (other)
• Locations: 1 site (Salt Lake City, Utah)
• Trial ID: NCT05959005 on ClinicalTrials.gov

What this trial studies

This observational study focuses on early atrophic age-related macular degeneration (AMD), a critical phase where patients experience limited visual dysfunction but are at high risk for significant vision loss. The research aims to enhance understanding of disease progression and identify risk factors for accelerated visual decline. Utilizing advanced retinal imaging and functional testing, the study will assess visual-related quality of life and microstructural changes in the retina. By characterizing these early lesions, the study seeks to inform potential therapeutic interventions tailored to this specific stage of AMD.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older with specific genetic risk factors for AMD and at least one early atrophic lesion.

Not a fit: Patients without the specified genetic risk alleles or those in earlier stages of AMD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for preventing vision loss in patients with early atrophic AMD.

How similar studies have performed: While there is ongoing research in AMD, this specific focus on early atrophic lesions represents a novel approach that has not been extensively tested.

Eligibility criteria

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).

Where this trial is running

Salt Lake City, Utah

• University of Utah — Salt Lake City, Utah, United States (RECRUITING)

Study contacts

• Principal investigator: Monika Fleckenstein — University of Utah
• Study coordinator: Ray Nelson

Conditions: Age-Related Macular Degeneration, iRORA, cRORA, Geographic Atrophy, non-exudative