Lesion-tailored, Fundus-controlled Perimetry in Geographic Atrophy (GA).

NCT07582042 | Not Yet Recruiting

• 1 other identifier: IRB_00197197
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Slope of mesopic retinal sensitivity decline (dB/year) at predefined distances from the Geographic Atrophy (GA) border.

  Quantify rates of mesopic sensitivity decline over time at defined distances from the Geographic Atrophy (GA) boundary.

  Duration per participant: 24 months (36-month total project timeline including start-up, ~6-month recruitment, and ~3-month close-out/analysis).

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) in at least one eye will be included who already receive pegcetacoplan intravitreally according to the approved label as part of their routine clinical care. The study does not assign treatment prospectively; pegcetacoplan is prescribed and administered as part of routine clinical care at the discretion of the treating physician.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Apellis Pharmaceuticals, Inc.: collaborator

Study Sites (1)

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

Salt Lake City, Utah, 84132, United States

Location

Related Publications (4)

• Heier JS, Lad EM, Holz FG, Rosenfeld PJ, Guymer RH, Boyer D, Grossi F, Baumal CR, Korobelnik JF, Slakter JS, Waheed NK, Metlapally R, Pearce I, Steinle N, Francone AA, Hu A, Lally DR, Deschatelets P, Francois C, Bliss C, Staurenghi G, Mones J, Singh RP, Ribeiro R, Wykoff CC; OAKS and DERBY study investigators. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. Lancet. 2023 Oct 21;402(10411):1434-1448. doi: 10.1016/S0140-6736(23)01520-9.

  PMID: 37865470 BACKGROUND

• Pfau M, Muller PL, von der Emde L, Lindner M, Moller PT, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. MESOPIC AND DARK-ADAPTED TWO-COLOR FUNDUS-CONTROLLED PERIMETRY IN GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION. Retina. 2020 Jan;40(1):169-180. doi: 10.1097/IAE.0000000000002337.

  PMID: 30300264 BACKGROUND

• Pfau M, Jolly JK, Wu Z, Denniss J, Lad EM, Guymer RH, Fleckenstein M, Holz FG, Schmitz-Valckenberg S. Fundus-controlled perimetry (microperimetry): Application as outcome measure in clinical trials. Prog Retin Eye Res. 2021 May;82:100907. doi: 10.1016/j.preteyeres.2020.100907. Epub 2020 Oct 3.

  PMID: 33022378 BACKGROUND

• Fleckenstein M, Schmitz-Valckenberg S, Chakravarthy U. Age-Related Macular Degeneration: A Review. JAMA. 2024 Jan 9;331(2):147-157. doi: 10.1001/jama.2023.26074.

  PMID: 38193957 BACKGROUND

Study Officials

• Monika Fleckenstein, MD

  University of Utah, Department of Ophthalmology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Mireles

CONTACT

+1; jenny.mireles@utah.edu

Ray Nelson

CONTACT

+1; ray.nelson@hsc.utah.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Ophthalmology and Visual Sciences

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

US (1)