This study is in progress, not accepting new patients

Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

a study on Geographic Atrophy Macular Degeneration

Summary

Eligibility
for people ages 50 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

Patients who completed Study ISEE2008 (GATHER2) and consent to participate will be administered monthly avacincaptad pegol 2 mg.

Official Title

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)

Details

Approximately 400 patients who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham) and consent to participate will be administered monthly avacincaptad pegol 2 mg from Month 1 through Month 17 (maximum 17 total doses); or until avacincaptad pegol is commercially available. All patients will have a final follow up visit at Month 18.

Keywords

Geographic Atrophy, Macular Degeneration, Atrophy, Avacincaptad pegol 2 mg intravitreal injection, Avacincaptad pegol 2 mg

Eligibility

You can join if…

Open to people ages 50 years and up

  • 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.

You CAN'T join if...

  • 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  • Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

Locations

  • Jules Stein Eye Institute David Geffen School of Medicine
    Los Angeles California 90095 United States
  • Doheny Eye Center, UCLA
    Pasadena California 91105 United States
  • Jacobs Retina Center at The Shiley Eye Institute USCD
    La Jolla California 92093 United States
  • Eye Medical Center of Fresno
    Fresno California 93720 United States
  • Orange County Retinal Med Group
    Santa Ana California 92705 United States
  • Retina Consultants of Orange County
    Fullerton California 92835 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
IVERIC bio, Inc.
ID
NCT05536297
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 278 people participating
Last Updated