Clinical trial NCT05536297: Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Geographic Atrophy
Age-Related Macular Degeneration
Keywords: Geographic Atrophy;
Macular Degeneration;
ARC1905;
Avacincaptad pegol;
Zimura (previous name);
Izervay
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 278
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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* Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to 18 Months
Secondary outcomes:
measure: Number of participants with Anti-Drug Antibody (ADA) status
timeFrame: Up to 18 Months
measure: Pharmacokinetics (PK) of avacincaptad pegol in plasma: concentration
timeFrame: Up to 18 Months
Other outcomes:
Locations:
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Fresno
country: United States
facility: Eye Medical Center of Fresno
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: La Jolla
country: United States
facility: Jacobs Retina Center at The Shiley Eye Institute USCD
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute David Geffen School of Medicine
state: California
city: Pasadena
country: United States
facility: Doheny Eye Center, UCLA
state: California
city: Redlands
country: United States
facility: Retina Consultants of Southern California
state: California
city: Santa Ana
country: United States
facility: Orange County Retinal Med Group
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern CO
state: Colorado
city: Lakewood
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Sarasota
country: United States
facility: Retina Associates of Sarasota
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Tallahassee
country: United States
facility: Southern Vitreoretinal Associates
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina & Macula Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center P.C.
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii, Inc.
state: Hawaii
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Wichita
country: United States
facility: Vitreo Retinal Consultants & Surgeons
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Chevy Chase
country: United States
facility: The Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Springfield
country: United States
facility: Retina Research Institute at New England Retina
state: Massachusetts
city: Worcester
country: United States
facility: Vitreoretinal Associates PC
state: Massachusetts
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of Central New York
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associates
state: North Carolina
city: Ashland
country: United States
facility: Retina & Vitreous Center of Southern Oregon, PC
state: Oregon
city: Portland
country: United States
facility: Retina Northwest PC
state: Oregon
city: Portland
country: United States
facility: Eye Health Northwest
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina - Wills Eye Institute
state: Pennsylvania
city: West Mifflin
country: United States
facility: Associates in Ophthalmology
state: Pennsylvania
city: Beaufort
country: United States
facility: Retina Research of Beaufort
state: South Carolina
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Knoxville
country: United States
facility: Southeastern Retina Associates, PC
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas, LLC
state: Texas
city: Amarillo
country: United States
facility: Southwest Retina Specialists
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Retina Associates of Utah PC
state: Utah
city: Bellevue
country: United States
facility: Pacific Northwest Retina
state: Washington
city: Rosario
country: Argentina
facility: Oftalmólogos Especialistas
state: Sante Fe
city: Buenos Aires
country: Argentina
facility: Centro Oftalmológico Dr. Charles
city: Buenos Aires
country: Argentina
facility: Instituto Oftalmologico de Buenos Aires
city: Mendoza
country: Argentina
facility: Oftar Mendoza
city: Santa Fe
country: Argentina
facility: Microcirugia Ocular
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
city: Sydney
country: Australia
facility: Sydney Retina Clinic
city: Styria
country: Austria
facility: Medizinische Universitat Graz
city: Tyrol
country: Austria
facility: Medizinische Universitat Innsbruck
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Ophthalmology and Optometry
city: Brussels
country: Belgium
facility: Centre H. U. Brugmann
city: Belo Horizonte
country: Brazil
facility: Centro de Ensino e Pesquisa do Instituto de Visao
city: São Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
city: São Paulo
country: Brazil
facility: IPEPO - Instituto da Visao
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
city: Ottawa
country: Canada
facility: Retina Centre of Ottawa
state: Ontario
city: Bogota
country: Colombia
facility: Fundacion Oftalmologica Nacional
city: Medellin
country: Colombia
facility: Clinica de Oftalmologia Sandiego
city: Osijek
country: Croatia
facility: Clinical Hospital Osiiek, Ophthalmology Clinic
city: Smíchov
country: Czechia
facility: Lékárna nad Knížecí Kováků
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Créteil
country: France
facility: Hopital Intercommunal de Creteil
city: Ecully
country: France
facility: Pole Vision Val D'Ouest
city: Lyon
country: France
facility: Centre Ophtalmologique Rabelais
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
city: Marseille
country: France
facility: Centre Paradis-Monticelli
city: Paris
country: France
facility: Centre D'exploration Ophtalmologique De L'odéon
city: Paris
country: France
facility: Centre d'Imagerie et Laser
city: Paris
country: France
facility: Rothschild Foundation
city: Paris
country: France
facility: Hopital Lariboisiere, Service Pharmacie
city: Saint Cyr sur Loire
country: France
facility: Centre Ophtalmologique Saint Exupéry
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf
city: Hannover
country: Germany
facility: Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover
city: München
country: Germany
facility: Augenklinik der Ludwig-Maximilian Universität München
city: München
country: Germany
facility: Eye Clinic Ludwig Maximilian
city: Münster
country: Germany
facility: Augenzentrum am St. Franziskus-Hospital
city: Budapest
country: Hungary
facility: Dept. of Ophthalmology Semmelweis University Budapest
city: Budapest
country: Hungary
facility: Bajcsy Zsilinszky Korhaz Szemeszet
city: Budapest
country: Hungary
facility: Budapest Retina Associates
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tzrifin
country: Israel
facility: Shamir Medical Center
city: Bologna
country: Italy
facility: AOU Policlinico S. Orsola-Malpighi
city: Chieti
country: Italy
facility: Clinica Oftalmologica Ospedale C. S.S. Annunziata
city: Ferrara
country: Italy
facility: Ospedaliero Universitaria di Ferrara
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Milano
country: Italy
facility: Azienda Ospedaliera Fatebenefratelli
city: Napoli
country: Italy
facility: Azienda Ospedaliera U. della Campania "Vanvitelli"
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Torrette Di Ancona
country: Italy
facility: Azienda Ospedaliero-U.Ospedali Riuniti Umberto I
city: Riga
country: Latvia
facility: P. Stradins Clinical university hospital
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Clinicade Oftalmologia Barraquer
city: Barcelona
country: Spain
facility: Institut Catala de la Retina
city: Bilbao
country: Spain
facility: Instituto Clinico Quirurgico de Oftalmologia
city: Cordoba
country: Spain
facility: Hospital La Arruzafa
city: Sant Cugat del Valles
country: Spain
facility: Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro
city: Santiago de Compostela
country: Spain
facility: Instituto Oftalmológico Gómez-Ulla
city: Valencia
country: Spain
facility: IMED Servicio Oftalmología
city: Valladolid
country: Spain
facility: Rio Hortega University Hospital
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario "Lozano Blesa"
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: