Recruiting

Pegcetacoplan

Sponsor:

University of Utah

Code:

NCT07582042

Conditions

Geographic Atrophy From Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Geographic Atrophy From Age-related Macular Degeneration

Study ID

NCT07582042

Start date

Jun 15, 2026

Status verified date

Jun, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

May 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Slope of mesopic retinal sensitivity decline (dB/year) at predefined distances from the Geographic Atrophy (GA) border. [ Time Frame: Duration per participant: 24 months (36-month total project timeline including start-up, ~6-month recruitment, and ~3-month close-out/analysis). ]

Central Contacts and Locations

Central contacts

Jenny Mireles

+1jenny.mireles@utah.edu

Ray Nelson

+1ray.nelson@hsc.utah.edu

Locations

University of Utah, Department of Ophthalmology, John A. Moran Eye Center

Recruiting

Salt Lake City, Utah, United States, 84132

More Information

Sponsor

University of Utah

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-06-17.