Safety Assessment of Pegcetacoplan in Patients with Neovascular AMD
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Study Drug
Apellis Clinical Site
Beverly Hills, California, United States
Apellis Clinical Site
Hagerstown, Maryland, United States
Apellis Clinical Site
Cleveland, Ohio, United States
Apellis Clinical Site
Houston, Texas, United States
Number of Subjects Experiencing Ocular and Systemic Treatment-Emergent Adverse Events (TEAEs) Including by Maximum Severity
TEAEs were defined as those adverse events (AEs) that developed or worsened after the first dose of study drug, up to 30 days after the last dose. The severity of the TEAEs was classified as mild (asymptomatic/mild symptoms); moderate (minimal, local/non-invasive intervention indicated); severe (medically significant but not life-threatening); life-threatening or leading to death. The number of subjects experiencing 1 TEAE in each category is presented. A maximum of 7 injections of pegcetacoplan (per subject) and a maximum of 13 injections of anti-VEGF (per subject) were received during the study.
Time frame: Day 1 up to end of study (up to 1 year).
Mean Change From Baseline in SD-OCT Central Subfield Thickness (CST) up to 12 Months
The CST was measured using SD-OCT throughout the study and the mean change from baseline at each timepoint is presented for the study eye.
Time frame: Day 1 up to Day 360 (12 months).
Number of Subjects With Clinically Significant Change From Baseline in Physical Examination Findings, Vital Signs and Laboratory Parameters
Physical examinations, vital signs and laboratory parameters were monitored throughout the study and any subjects showing a clinically significant change from baseline over the study period are presented.
Time frame: Baseline (Screening or Day 1) up to end of study (up to 1 year).
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