An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 278
- Locations
- 117
- Primary Endpoint
- Number of participants with Adverse Events (AEs)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients aged 50 years or greater diagnosed with GA inside and/or outside of the fovea who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment.
- •Patient must provide new written informed consent for this OLE trial prior to participation.
- •Patient must have the ability to return for all trial visits for the duration of the 18-month trial.
Exclusion Criteria
- •Patient did not complete Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).
- •Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.
- •Patient did not enroll into this OLE trial within the 90 day enrollment period.
- •Patient who is pregnant or nursing.
Arms & Interventions
avacincaptad pegol
Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.
Intervention: avacincaptad pegol (Drug)
Outcomes
Primary Outcomes
Number of participants with Adverse Events (AEs)
Time Frame: Up to 18 Months
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.
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 18 months
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.
Secondary Outcomes
- Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration(Up to 18 Months)
- Number of participants with Anti-Drug Antibody (ADA) status(Up to 18 Months)
- Number of Participants With Anti-drug Antibody (ADA)(Up to 18 months)
- Plasma Concentrations of ACP(Months 1, 2, 4, 7, 13, and 18)