Lesion-tailored, Fundus-controlled Perimetry in Geographic Atrophy (GA).
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65-90
SponsorUniversity of Utah
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 65-90 years.
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
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Duration per participant: 24 months (36-month total project timeline including start-up, ~6-month recruitment, and ~3-month close-out/analysis).Sponsors and contacts
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University of Utah
Lead sponsor
Apellis Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov