The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 23 visit on study treatment (either avacincaptad pegol or Sham).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
278
Intravitreal Injection
Number of Participants With Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a participant including unfavorable and unintended signs, symptoms or disease temporally associated with the use of a medicinal product and which does not necessarily have to have a causal relationship to this treatment. AEs include illnesses with onset during the trial, or exacerbations of pre-existing illnesses. Exacerbation of pre-existing illness is defined as a significant increase in the severity of the illness as compared to the start of the trial and was considered when a participant requires new or additional treatment for that illness. Lack of or insufficient clinical response or efficacy was not recorded as an AE.
Time frame: Up to 18 months
Number of Participants With Anti-drug Antibody (ADA)
Number of participants with ADA = Post-baseline positive (in Baseline negative group) + treatment-boosted ADA positive (in Baseline positive group) / participants with a Baseline and at least one post-baseline sample. For participants whose ADA status is positive at Baseline, a post-baseline titer value that is \>= 4 times higher than the Baseline is considered treatment-boosted ADA.
Time frame: Up to 18 months
Plasma Concentrations of ACP
Concentrations below the lower limit of quantification (3.36 ng/mL) are set to zero for calculation of summary statistics.
Time frame: Months 1, 2, 4, 7, 13, and 18
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