NCT07582042 · University of Utah
Lesion-tailored, Fundus-controlled Perimetry in Geographic Atrophy (GA).
(FCPGA-2025)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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).
Quantify rates of mesopic sensitivity decline over time at defined distances from the Geographic Atrophy (GA) boundary.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Salt Lake City, Utah
Collaborators
Apellis Pharmaceuticals, Inc.
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations