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 24 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 should be considered when a participant requires new or additional treatment for that illness.
Time frame: Up to 18 Months
Number of participants with Anti-Drug Antibody (ADA) status
ADA will be recorded from the serum samples collected. Overall ADA status will be reported: ADA-negative, ADA positive, ADA-inconclusive and unevaluable sample.
Time frame: Up to 18 Months
Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration
Concentration will be recorded from the PK plasma samples collected.
Time frame: Up to 18 Months
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