Phase 3
N=278
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
Geographic Atrophy · Age-Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT05536297 ↗Enrolled (actual)
278
Serious AEs
18.5%
Results posted
Apr 2026
Primary outcome: Primary: Number of Participants With Adverse Events (AEs) — 50; 49; 129 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- avacincaptad pegol (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Global Development, Inc.
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
50; 49; 129 | — |
| SECONDARY Number of Participants With Anti-drug Antibody (ADA) |
1; 0; 2 | — |
| SECONDARY Plasma Concentrations of ACP |
9.17; 5.97; 0.0440; 35.6; 31.7; 31.9 | — |
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).
Eligibility Criteria
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- Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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.
Data sourced from ClinicalTrials.gov (NCT05536297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.