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