Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

Completed · Phase 3

Conditions studied: Geographic Atrophy, Age-Related Macular Degeneration

In brief

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).

Key facts

Study ID

NCT05536297

Run by

Astellas Pharma Global Development, Inc.

People needed

278

Starts

2022-09-26

Expected to finish

2025-04-10

Last updated by the study team

2026-05-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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• Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

Where it is running

• Eye Medical Center of Fresno — Fresno, California, United States
• Retina Consultants of Orange County — Fullerton, California, United States
• Jacobs Retina Center at The Shiley Eye Institute USCD — La Jolla, California, United States
• Jules Stein Eye Institute David Geffen School of Medicine — Los Angeles, California, United States
• Doheny Eye Center, UCLA — Pasadena, California, United States
• Retina Consultants of Southern California — Redlands, California, United States
• Orange County Retinal Med Group — Santa Ana, California, United States
• University of Colorado — Aurora, Colorado, United States
• Retina Consultants of Southern CO — Colorado Springs, Colorado, United States
• Colorado Retina Associates, PC — Lakewood, Colorado, United States
• Rand Eye Institute — Deerfield Beach, Florida, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Retina Care Specialists — Palm Beach Gardens, Florida, United States
• Retina Associates of Sarasota — Sarasota, Florida, United States
• Retina Vitreous Associates of Florida — St. Petersburg, Florida, United States
• East Florida Eye Institute — Stuart, Florida, United States
• Southern Vitreoretinal Associates — Tallahassee, Florida, United States
• Center for Retina & Macula Disease — Winter Haven, Florida, United States
• Southeast Retina Center P.C. — Augusta, Georgia, United States
• Retina Consultants of Hawaii, Inc. — ‘Aiea, Hawaii, United States
• Illinois Eye Center — Peoria, Illinois, United States
• Vitreo Retinal Consultants & Surgeons — Wichita, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Retinal Diagnostic Center — Campbell, California, United States

Full record on ClinicalTrials.gov

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