Geographic Atrophy
Conditions
Brief summary
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
Interventions
DRUGPegcetacoplan
Administered intravitreally (IVT) in eyes with geographic atrophy (GA)
Sponsors
Apellis Pharmaceuticals, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eyes are eligible to be included in the study only if all of the following criteria apply. Ocular-specific inclusion criteria apply to the treated eye(s), unless otherwise specified. * Eyes that are naive to treatment with pegcetacoplan that are prescribed pegcetacoplan per routine clinical practice according to approved pegcetacoplan prescribing information (ie, the clinical decision to treat with pegcetacoplan must be made before study participation is discussed with the patient) * Patient age ≥60 years * Visual acuity better than 20/200 on Snellen chart * Clinical diagnosis of GA of the macula secondary to AMD in one or both eyes as determined by the investigator using OCT and/or FAF imaging * GA lesion meeting the following criteria as determined by the investigator's assessment of Spectralis OCT and/or FAF images at screening: 1. Nonsubfoveal lesion(s) 2. GA lesion visualized in its entirety on the macula-centered OCT image and not contiguous with any areas of peripapillary atrophy 3. Presence of any pattern of hyperautofluorescence in the junctional zone of GA; absence of hyperautofluorescence (ie, pattern = none) exclusionary * Adequate clarity of ocular media and adequate pupillary dilation and fixation to permit the collection of good quality images as determined by the investigator * Patient willing and able to give informed consent and to comply with the study procedures and assessments
Exclusion criteria
Ocular-specific
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of ocular AEs in treated eyes overall and according to physician-directed treatment interval based on US prescribing information | Up to 36 months |
| Incidence of other events of interest | Up to 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Assess real-world treatment patterns and use of pegcetacoplan considering the proportion of participants with bilateral GA treated with pegcetacoplan in both eyes | Up to 36 months |
| If only one eye is treated, the criteria for determination of the eye to be treated | Up to 36 months |
| The treatment interval (mean days between injections) over time | 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 | Up to 36 months |
| The treatment adherence to planned dosing frequency: the number of injections administered divided by the number of injections planned | Up to 36 months |
| The duration of persistence on treatment: continuous medication usage until a gap of ≥3 months | Up to 36 months |
| The treatment discontinuation and/or switching to other agents approved for treatment of GA | Up to 36 months |
| The management of new-onset exudative age-related macular degeneration (eAMD) events in eyes treated with pegcetacoplan in clinical practice | Up to 36 months |
| The proportion of treated eyes that develop eAMD that receive anti-vascular endothelial growth factor (VEGF) injections | Up to 36 months |
| The number of anti-VEGF injections per month from diagnosis of eAMD | Up to 36 months |
| The proportion of anti-VEGF injections given on same day in the same eye as pegcetacoplan | Up to 36 months |
Countries
United States
Outcome results
None listed