A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration
Study Type
OBSERVATIONAL
Enrollment
300
Administered intravitreally (IVT) in eyes with geographic atrophy (GA)
California Retina Consultants (01-026)
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group (01-020)
Beverly Hills, California, United States
Illinois Retina Associates (01-035)
Fullerton, California, United States
Retinal Consultants Medical Group Inc (01-008)
Modesto, California, United States
Retina Consultants San Diego Inc. (01-018)
Poway, California, United States
Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information
Time frame: Up to 36 months
Incidence of other events of interest
Time frame: Up to 36 months
Assess real-world treatment patterns and use of pegcetacoplan considering the proportion of participants with bilateral GA treated with pegcetacoplan in both eyes
Time frame: Up to 36 months
If only one eye is treated, the criteria for determination of the eye to be treated
Time frame: Up to 36 months
The treatment interval (mean days between injections) over time
Time frame: Up to 36 months
The frequency of imaging on treated eyes (color fundus photography, spectral domain optical coherence tomography [SD-OCT], fundus autofluorescence, optical coherence tomography angiography [OCT-A
Time frame: Up to 36 months
The treatment adherence to planned dosing frequency: the number of injections administered divided by the number of injections planned
Time frame: Up to 36 months
The duration of persistence on treatment: continuous medication usage until a gap of ≥3 months
Time frame: Up to 36 months
The treatment discontinuation and/or switching to other agents approved for treatment of GA
Time frame: Up to 36 months
The management of new-onset exudative age-related macular degeneration (eAMD) events in eyes treated with pegcetacoplan in clinical practice
Time frame: Up to 36 months
The proportion of treated eyes that develop eAMD that receive anti-vascular endothelial growth factor (VEGF) injections
Time frame: Up to 36 months
The number of anti-VEGF injections per month from diagnosis of eAMD
Time frame: Up to 36 months
The proportion of anti-VEGF injections given on same day in the same eye as pegcetacoplan
Time frame: Up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
California Retina Consultants (01-027)
Santa Barbara, California, United States
Bay Area Retina Associates (01-005)
Walnut Creek, California, United States
Colorado Retina Associates, PLLC (01-011)
Lakewood, Colorado, United States
Retina Specialty Institute (01-019)
Pensacola, Florida, United States
South East Retina Center, PC (01-030)
Augusta, Georgia, United States
...and 24 more locations