Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

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)

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 Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration; Geographic Atrophy
• Intervention / Treatment: Drug: avacincaptad pegol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1116
    • Centro Oftalmológico Dr. Charles
  • Buenos Aires, Argentina, 1830
    • Instituto Oftalmologico de Buenos Aires
  • Mendoza, Argentina, 5500
    • Oftar Mendoza
  • Santa Fe, Argentina
    • Microcirugia Ocular
  • Sante Fe
    • Rosario, Sante Fe, Argentina, S2000ANJ
      • Oftalmólogos Especialistas
• Australia
  • East Melbourne, Australia, 3002
    • Centre For Eye Research Australia
  • Sydney, Australia, 2000
    • Sydney Retina Clinic
• Austria
  • Styria, Austria, 8036
    • Medizinische Universität Graz
  • Tyrol, Austria, 6020
    • Medizinische Universität Innsbruck
  • Vienna, Austria, 1090
    • Medical University of Vienna, Department of Ophthalmology and Optometry
• Belgium
  • Brussels, Belgium, 1020
    • Centre H. U. Brugmann
• Brazil
  • Belo Horizonte, Brazil, 30330-00
    • Centro de Ensino e Pesquisa do Instituto de Visao
  • São Paulo, Brazil, 04038-032
    • IPEPO - Instituto da Visao
  • São Paulo, Brazil, 04023-062
    • Universidade Federal de Sao Paulo
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2H 0C8
      • Calgary Retina Consultants
  • Ontario
    • London, Ontario, Canada, N6A4V2
      • St. Joseph's Health Care London
    • Ottawa, Ontario, Canada, K2B 7E9
      • Retina Centre of Ottawa
• Colombia
  • Bogotá, Colombia, 110231
    • Fundacion Oftalmologica Nacional
  • Medellín, Colombia, 00000
    • Clinica de Oftalmologia Sandiego
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Osiiek, Ophthalmology Clinic
• Czechia
  • Smíchov, Czechia, 150 00
    • Lékárna nad Knížecí Kováků
• France
  • Bordeaux, France, 33000
    • University Hospital of Bordeaux
  • Créteil, France, 94010
    • Hôpital Intercommunal de Créteil
  • Lyon, France, 69317
    • Hopital De La Croix-Rousse
  • Lyon, France, 69002
    • Centre Ophtalmologique Rabelais
  • Marseille, France, 13008
    • Centre Paradis-Monticelli
  • Paris, France, 75006
    • Centre D'exploration Ophtalmologique De L'odéon
  • Paris, France, 75015
    • Centre d'Imagerie et Laser
  • Paris, France, 75019
    • Rothschild Foundation
  • Paris, France, 75745
    • Hopital Lariboisiere, Service Pharmacie
  • Saint-Cyr-sur-Loire, France, 37540
    • Centre Ophtalmologique Saint Exupéry
  • Écully, France, 69130
    • Pole Vision Val d'Ouest
• Germany
  • Hamburg, Germany, 20251
    • Universitätsklinikum Hamburg Eppendorf
  • Hanover, Germany, 30625
    • Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover
  • München, Germany, 80336
    • Augenklinik der Ludwig-Maximilian Universität München
  • München, Germany, 80336
    • Eye Clinic Ludwig Maximilian
  • Münster, Germany, 48145
    • Augenzentrum am St. Franziskus-Hospital
• Hungary
  • Budapest, Hungary, 1133
    • Budapest Retina Associates
  • Budapest, Hungary, 1085
    • Dept. of Ophthalmology Semmelweis University Budapest
  • Budapest, Hungary, 1106
    • Bajcsy Zsilinszky Korhaz Szemeszet
• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center
  • Haifa, Israel, 3436212
    • Carmel Medical Center
  • Rehovot, Israel, 94410606
    • Kaplan Medical Center
  • Tzrifin, Israel, 70300
    • Shamir Medical Center
• Italy
  • Bologna, Italy, 40138
    • Aou Policlinico S. Orsola-Malpighi
  • Chieti, Italy, 66100
    • Clinica Oftalmologica Ospedale C. S.S. Annunziata
  • Ferrara, Italy, 44124
    • Ospedaliero Universitaria di Ferrara
  • Milan, Italy, 20132
    • Ospedale San Raffaele
  • Milan, Italy, 20122
    • Ospedale Maggiore Policlinico
  • Milan, Italy, 20157
    • Azienda Ospedaliera Fatebenefratelli
  • Naples, Italy, 80131
    • Azienda Ospedaliera U. della Campania "Vanvitelli"
  • Roma, Italy, 00133
    • Policlinico Tor Vergata
  • Torrette Di Ancona, Italy, 60126
    • Azienda Ospedaliero-U.Ospedali Riuniti Umberto I
• Latvia
  • Riga, Latvia, LV-1002
    • P. Stradins Clinical University Hospital
• Spain
  • Barcelona, Spain, 08021
    • Clinicade Oftalmologia Barraquer
  • Barcelona, Spain, 08022
    • Institut Catala de la Retina
  • Bilbao, Spain, 48010
    • Instituto Clinico Quirurgico de Oftalmologia
  • Córdoba, Spain, 14003
    • Hospital La Arruzafa
  • Sant Cugat del Vallès, Spain, 08195
    • Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro
  • Santiago de Compostela, Spain, 15706
    • Instituto Oftalmológico Gómez-Ulla
  • Valencia, Spain, 46100
    • IMED Servicio Oftalmología
  • Valladolid, Spain, 47012
    • Rio Hortega University Hospital
  • Zaragoza, Spain, 50009
    • Hospital Clínico Universitario "Lozano Blesa"
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro-Majadahonda
• United States
  • California
    • Campbell, California, United States, 95008
      • Retinal Diagnostic Center
    • Fresno, California, United States, 93720
      • Eye Medical Center of Fresno
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • La Jolla, California, United States, 92093
      • Jacobs Retina Center at The Shiley Eye Institute USCD
    • Los Angeles, California, United States, 90095
      • Jules Stein Eye Institute David Geffen School of Medicine
    • Pasadena, California, United States, 91105
      • Doheny Eye Center, UCLA
    • Redlands, California, United States, 92374
      • Retina Consultants of Southern California
    • Santa Ana, California, United States, 92705
      • Orange County Retinal Med Group
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Retina Consultants of Southern CO
    • Lakewood, Colorado, United States, 80228
      • Colorado Retina Associates, PC
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
    • Fort Lauderdale, Florida, United States, 33308
      • Retina Group of Florida
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates
    • Palm Beach Gardens, Florida, United States, 33410
      • Retina Care Specialists
    • Sarasota, Florida, United States, 34233
      • Retina Associates of Sarasota
    • St. Petersburg, Florida, United States, 33711
      • Retina Vitreous Associates of Florida
    • Stuart, Florida, United States, 34994
      • East Florida Eye Institute
    • Tallahassee, Florida, United States, 32308
      • Southern Vitreoretinal Associates
    • Winter Haven, Florida, United States, 33880
      • Center for Retina & Macula Disease
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center P.C.
  • Hawaii
    • ‘Aiea, Hawaii, United States, 96701
      • Retina Consultants of Hawaii, Inc.
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Eye Center
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Vitreo Retinal Consultants & Surgeons
  • Louisiana
    • New Orleans, Louisiana, United States, 70124
      • Ochsner Clinic Foundation
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • The Retina Group of Washington
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Springfield, Massachusetts, United States, 01107
      • Retina Research Institute at New England Retina
    • Worcester, Massachusetts, United States, 01605
      • Vitreoretinal Associates PC
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New York
    • Liverpool, New York, United States, 13088
      • Retina Vitreous Surgeons of Central New York
    • Oceanside, New York, United States, 11572
      • Ophthalmic Consultants of Long Island
    • Rochester, New York, United States, 14620
      • Retina Associates of Western NY
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associates
  • Oregon
    • Ashland, Oregon, United States, 97520
      • Retina & Vitreous Center of Southern Oregon, PC
    • Portland, Oregon, United States, 97221
      • Retina Northwest PC
    • Portland, Oregon, United States, 97225
      • Eye Health Northwest
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina - Wills Eye Institute
    • West Mifflin, Pennsylvania, United States, 15122
      • Associates in Ophthalmology
  • South Carolina
    • Beaufort, South Carolina, United States, 29902
      • Retina Research of Beaufort
    • West Columbia, South Carolina, United States, 29169
      • Palmetto Retina Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Southeastern Retina Associates, PC
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Research Institute of Texas, LLC
    • Amarillo, Texas, United States, 79106
      • Southwest Retina Specialists
    • Austin, Texas, United States, 78705
      • Austin Retina Associates
    • Dallas, Texas, United States, 75231
      • Retina Foundation of the Southwest
    • Southlake, Texas, United States, 76092
      • Retina Center of Texas
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah PC
  • Washington
    • Bellevue, Washington, United States, 98004
      • Pacific Northwest Retina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: avacincaptad pegol; Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.	Drug: avacincaptad pegol; Intravitreal Injection; Other Names: ARC1905; Izervay; Zimura (previous name)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Anti-drug Antibody (ADA)	Number of participants with ADA = Post-baseline positive (in Baseline negative group) + treatment-boosted ADA positive (in Baseline positive group) / participants with a Baseline and at least one post-baseline sample. For participants whose ADA status is positive at Baseline, a post-baseline titer value that is >= 4 times higher than the Baseline is considered treatment-boosted ADA.	Up to 18 months
Plasma Concentrations of ACP	Concentrations below the lower limit of quantification (3.36 ng/mL) are set to zero for calculation of summary statistics.	Months 1, 2, 4, 7, 13, and 18

Collaborators and Investigators

• Sponsor: Astellas Pharma Global Development, Inc.
• Investigators: Study Director: Medical Director, Astellas Pharma Global Development, Inc.

Publications and helpful links

Helpful Links

• Link to plain language summary of the study on the Trial Results Summaries website.
• Link to results and other applicable study documents on the Astellas Clinical Trials website.

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): April 10, 2025
• Study Completion (Actual): April 10, 2025

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 7, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Geographic Atrophy;; Macular Degeneration;; ARC1905;; Avacincaptad pegol;; Izervay; Zimura (previous name)
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: ISEE2009; 2022-002860-59 (EudraCT Number); 2024-515185-13-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No