Lesion-tailored, Fundus-controlled Perimetry in Geographic Atrophy (GA). (FCPGA-2025)

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Geographic Atrophy From Age-related Macular Degeneration

Detailed Description

The study will prospectively recruit patients from the Retina Clinics at the John A. Moran Eye Center and its satellite clinics.

All team members will be trained and certified for their specific tasks to ensure that uniform procedures are followed in order to obtain comparable and reliable data.

The following study procedures will be performed after informed consent has been obtained (in chronologic order):

• Assessment of past and current ophthalmic history, and demographic details
• Best-corrected visual acuity (BCVA) for both eyes measured by Early Treatment Diabetic Retinopathy Study (ETDRS) or Snellen charts (performed at Visit [V]1, V2, V4 and V6)

• Fundus-controlled perimetry (FCP)

  • Training Test (performed at V1, V2, V3, V4, V5, V6)
  • Fixes macula pattern (performed at V1 and V6)
  • Patient-tailored pattern (performed at V2 [twice for test - re-test assessment], V3, V4, V5, V6)
• Vision Impairment in Low Luminance with 33 items (VILL-33), a 33-item questionnaire (performed at V2, V4, and V6)
• Fundus autofluorescence (FAF), near infrared (NIR) and simultaneous spectral domain optical coherence tomography (SD-OCT) imaging (performed at V1, V4 and V6)
• Color digital fundus photographs (optional at visits V1, V4, and V6)
• OCT-angiography (OCT-A) imaging (optional at visits V1, V4 and V6)

Data to be obtained and analyzed will include each participant's medical and ophthalmic history, current medications, smoking history, body mass index (BMI), and demographic information. Additional research data will include records of any adverse events, functional testing results such as best-corrected visual acuity (BCVA) and fundus-controlled perimetry (FCP), and digital imaging data including color fundus photographs, fundus autofluorescence (FAF) images, near-infrared reflectance (NIR) images, optical coherence tomography (OCT) images, and optical coherence tomography angiography (OCT-A) images.

Study data and documentation will be monitored throughout the study to ensure accuracy, completeness, and compliance with the approved protocol, Good Clinical Practice (GCP) standards, and institutional policies. Monitoring procedures will include periodic review of informed consent documentation and verification that data recorded in study forms and electronic databases are consistent with source documents.

Data management and analysis will be conducted by the Utah Retinal Reading Center (UREAD). UREAD will develop comprehensive study-specific documentation, including a Data Management Manual and a Grading Manual, which will outline standardized protocols for data processing, grading procedures, and quality assurance.

Prior to initiating formal data analysis, all image graders will undergo standardized training and certification using curated training datasets. Each imaging dataset will be independently evaluated by two certified readers to ensure objectivity. In cases of disagreement, a senior grader will perform an arbitration review to determine the final grading outcome.

At the screening visit (V1), structural inclusion and exclusion criteria will be assessed to determine patient eligibility. The Reading Center will provide three types of FCP testing patterns in Extensible Markup Language (XML) format: Training Pattern; Fixed Central Macula Pattern; and a Patient-Tailored Pattern.

All imaging and test data will be securely transferred from the study site to UREAD for centralized grading and analysis. Quality control procedures will be implemented throughout the study to ensure data integrity and consistency.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Jenny Mireles; Phone Number: 801-585-5285 +1; Email: jenny.mireles@utah.edu
• Study Contact Backup: Name: Ray Nelson; Phone Number: 801-585-1890 +1; Email: ray.nelson@hsc.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah, Department of Ophthalmology, John A. Moran Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Apellis Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Monika Fleckenstein, MD, University of Utah, Department of Ophthalmology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: May 5, 2026
• First Submitted That Met QC Criteria: May 5, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00197197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This is a collaborative project with Apellis Pharmaceuticals. The data sharing is regulated in the Research Collaboration Agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No