NCT07582042 Lesion-tailored, Fundus-controlled Perimetry in Geographic Atrophy (GA).
| NCT ID | NCT07582042 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Geographic Atrophy From Age-related Macular Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2029-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-06-15 with a primary completion date of 2029-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to evaluate changes in retinal sensitivity over time in patients with geographic atrophy due to age related macular degeneration who are receiving pegcetacoplan as part of routine clinical care. The study aims to determine whether lesion tailored fundus-controlled perimetry can reliably measure functional changes near areas of atrophy and whether this testing can be implemented in everyday clinic care over 24 months. Participants will undergo repeated vision testing, standard eye imaging, and visual function questionnaires while continuing their prescribed treatment.
Eligibility 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.
Contact & Investigator
Monika Fleckenstein, MD
PRINCIPAL INVESTIGATOR
University of Utah, Department of Ophthalmology
Frequently Asked Questions
Who can join the NCT07582042 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 90 Years, studying Geographic Atrophy From Age-related Macular Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07582042 currently recruiting?
Yes, NCT07582042 is actively recruiting participants. Contact the research team at jenny.mireles@utah.edu for enrollment information.
Where is the NCT07582042 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT07582042 clinical trial?
NCT07582042 is sponsored by University of Utah. The principal investigator is Monika Fleckenstein, MD at University of Utah, Department of Ophthalmology. The trial plans to enroll 50 participants.