Lesion-tailored, fundus-controlled testing in geographic atrophy on pegcetacoplan
Official title: Integration of Lesion-tailored, Fundus-controlled Perimetry Into Routine Clinical Care for Patients With Geographic Atrophy (GA) Receiving Pegcetacoplan Treatment in Accordance With the Approved Label.
Run by University of Utah · NCT07582042 · Data updated 2026-11-12
This observational study tests whether lesion-tailored fundus-controlled perimetry can reliably track retinal sensitivity changes near atrophy in people with geographic atrophy who are receiving pegcetacoplan in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 65 Years to 90 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | May 1, 2029 |
| Study ends | August 1, 2029 |
| Registry record updated | June 17, 2026 |
| Trial ID | NCT07582042 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 65–90 with GA from dry AMD in at least one eye, on pegcetacoplan treatment, and able to undergo mesopic FCP and imaging.
✕Probably not a fit
Patients without GA in the required age range or not receiving pegcetacoplan, or those unable to complete the imaging/functional tests, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective study follows adults with geographic atrophy due to AMD who are treated with pegcetacoplan in real-world clinic settings. Participants undergo repeated vision testing, imaging, and questionnaires over 24 months to see if lesion-tailored fundus-controlled perimetry detects functional changes near atrophy. Standard tests include BCVA, FCP with training and pattern variations, and imaging such as FAF, NIR, SD-OCT, with optional color photos and OCT-A. Data collected cover medical history, medications, lifestyle, and demographics to support analysis of functional and imaging correlations.
Why it matters
Potential benefit: If successful, this approach could provide a practical way to monitor functional changes near GA areas during routine care.
How similar studies have gone: Prior work has explored functional testing near atrophy, but this study applies lesion-tailored, fundus-controlled perimetry in a real-world, pegcetacoplan-treated GA population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 65-90 years. * Geographic Atrophy (GA) secondary to dry Age-related Macular Degeneration (AMD) in at least one eye with the following criteria: * GA lesion size between 1 and 15 mm² (≈ 0.4 to 6 disc areas) * GA borders must be at least 500 μm from the edge of the 30° × 25° optical coherence tomography (OCT) image frame * No confluent GA extending into peripapillary atrophy * Receiving intravitreal pegcetacoplan per label (at least one injection before screening). * Best-corrected visual acuity (BCVA) of 0.1 - 1.0 logMAR (≈ 20/20 to 20/200 Snellen) * Able to undergo mesopic FCP and required imaging. * Informed consent provided. Exclusion Criteria: * Currently or previously active exudative macular neovascularization in the study eye. * High refractive errors (\> ±5.00 Diopters \[D\] spherical equivalent) and significant astigmatism (\> 2.50 D). * Ocular comorbidities likely to confound sensitivity or imaging (e.g., diabetic retinopathy with macular edema, retinal vein occlusion (RVO), inherited retinal disease, uncontrolled glaucoma). * Media opacity precluding reliable fundus-controlled perimetry (FCP) or imaging (e.g., dense cataract, corneal opacity, vitreous hemorrhage). * Any systemic condition judged likely to compromise participation, follow-up, or data integrity.
Where it's running
-
University of Utah, Department of Ophthalmology, John A. Moran Eye Center
Salt Lake City, Utah, United States Recruiting
Study contacts
- Principal investigator: Monika Fleckenstein, MD — University of Utah, Department of Ophthalmology
- Study coordinator: Jenny Mireles
- Email: jenny.mireles@utah.edu
- Phone: +1
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.