Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy

NCT ID: NCT05536297

Last Updated: 2025-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2025-04-10

Brief Summary

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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).

Detailed Description

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Conditions

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Geographic Atrophy Age-Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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avacincaptad pegol

Participants will receive avacincaptad pegol 2 mg monthly from Month 1 to Month 17.

Group Type EXPERIMENTAL

avacincaptad pegol

Intervention Type DRUG

Intravitreal Injection

Interventions

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avacincaptad pegol

Intravitreal Injection

Intervention Type DRUG

Other Intervention Names

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Zimura (previous name) ARC1905 Izervay

Eligibility Criteria

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* Patient who had the study drug permanently withdrawn for an AE during ISEE2008 are not eligible.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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Global Development, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Global Development, Inc.

Locations

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Retinal Diagnostic Center

Campbell, California, United States

Site Status

Eye Medical Center of Fresno

Fresno, California, United States

Site Status

Retina Consultants of Orange County

Fullerton, California, United States

Site Status

Jacobs Retina Center at The Shiley Eye Institute USCD

La Jolla, California, United States

Site Status

Jules Stein Eye Institute David Geffen School of Medicine

Los Angeles, California, United States

Site Status

Doheny Eye Center, UCLA

Pasadena, California, United States

Site Status

Retina Consultants of Southern California

Redlands, California, United States

Site Status

Orange County Retinal Med Group

Santa Ana, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Retina Consultants of Southern CO

Colorado Springs, Colorado, United States

Site Status

Colorado Retina Associates, PC

Lakewood, Colorado, United States

Site Status

Rand Eye Institute

Deerfield Beach, Florida, United States

Site Status

Retina Group of Florida

Fort Lauderdale, Florida, United States

Site Status

Florida Eye Associates

Melbourne, Florida, United States

Site Status

Retina Care Specialists

Palm Beach Gardens, Florida, United States

Site Status

Retina Associates of Sarasota

Sarasota, Florida, United States

Site Status

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

Site Status

East Florida Eye Institute

Stuart, Florida, United States

Site Status

Southern Vitreoretinal Associates

Tallahassee, Florida, United States

Site Status

Center for Retina & Macula Disease

Winter Haven, Florida, United States

Site Status

Southeast Retina Center P.C.

Augusta, Georgia, United States

Site Status

Retina Consultants of Hawaii, Inc.

‘Aiea, Hawaii, United States

Site Status

Illinois Eye Center

Peoria, Illinois, United States

Site Status

Vitreo Retinal Consultants & Surgeons

Wichita, Kansas, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

The Retina Group of Washington

Chevy Chase, Maryland, United States

Site Status

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Retina Research Institute at New England Retina

Springfield, Massachusetts, United States

Site Status

Vitreoretinal Associates PC

Worcester, Massachusetts, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

Site Status

Retina Vitreous Surgeons of Central New York

Liverpool, New York, United States

Site Status

Ophthalmic Consultants of Long Island

Oceanside, New York, United States

Site Status

Retina Associates of Western NY

Rochester, New York, United States

Site Status

Western Carolina Retinal Associates

Asheville, North Carolina, United States

Site Status

Retina & Vitreous Center of Southern Oregon, PC

Ashland, Oregon, United States

Site Status

Retina Northwest PC

Portland, Oregon, United States

Site Status

Eye Health Northwest

Portland, Oregon, United States

Site Status

Mid Atlantic Retina - Wills Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Associates in Ophthalmology

West Mifflin, Pennsylvania, United States

Site Status

Retina Research of Beaufort

Beaufort, South Carolina, United States

Site Status

Palmetto Retina Center

West Columbia, South Carolina, United States

Site Status

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Site Status

Southeastern Retina Associates, PC

Knoxville, Tennessee, United States

Site Status

Retina Research Institute of Texas, LLC

Abilene, Texas, United States

Site Status

Southwest Retina Specialists

Amarillo, Texas, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Retina Foundation of the Southwest

Dallas, Texas, United States

Site Status

Retina Center of Texas

Southlake, Texas, United States

Site Status

Retina Consultants of Houston

The Woodlands, Texas, United States

Site Status

Strategic Clinical Research Group, LLC

Willow Park, Texas, United States

Site Status

Retina Associates of Utah PC

Salt Lake City, Utah, United States

Site Status

Pacific Northwest Retina

Bellevue, Washington, United States

Site Status

Oftalmólogos Especialistas

Rosario, Sante Fe, Argentina

Site Status

Centro Oftalmológico Dr. Charles

Buenos Aires, , Argentina

Site Status

Instituto Oftalmologico de Buenos Aires

Buenos Aires, , Argentina

Site Status

Oftar Mendoza

Mendoza, , Argentina

Site Status

Microcirugia Ocular

Santa Fe, , Argentina

Site Status

Centre for Eye Research Australia

East Melbourne, , Australia

Site Status

Sydney Retina Clinic

Sydney, , Australia

Site Status

Medizinische Universitat Graz

Styria, , Austria

Site Status

Medizinische Universitat Innsbruck

Tyrol, , Austria

Site Status

Medical University of Vienna, Department of Ophthalmology and Optometry

Vienna, , Austria

Site Status

Centre H. U. Brugmann

Brussels, , Belgium

Site Status

Centro de Ensino e Pesquisa do Instituto de Visao

Belo Horizonte, , Brazil

Site Status

Universidade Federal de Sao Paulo

São Paulo, , Brazil

Site Status

IPEPO - Instituto da Visao

São Paulo, , Brazil

Site Status

Calgary Retina Consultants

Calgary, Alberta, Canada

Site Status

St. Joseph's Health Care London

London, Ontario, Canada

Site Status

Retina Centre of Ottawa

Ottawa, Ontario, Canada

Site Status

Fundacion Oftalmologica Nacional

Bogotá, , Colombia

Site Status

Clinica de Oftalmologia Sandiego

Medellín, , Colombia

Site Status

Clinical Hospital Osiiek, Ophthalmology Clinic

Osijek, , Croatia

Site Status

Lékárna nad Knížecí Kováků

Smíchov, , Czechia

Site Status

University Hospital of Bordeaux

Bordeaux, , France

Site Status

Hopital Intercommunal de Creteil

Créteil, , France

Site Status

Pole Vision Val D'Ouest

Écully, , France

Site Status

Centre Ophtalmologique Rabelais

Lyon, , France

Site Status

Hopital de la Croix-Rousse

Lyon, , France

Site Status

Centre Paradis-Monticelli

Marseille, , France

Site Status

Centre D'exploration Ophtalmologique De L'odéon

Paris, , France

Site Status

Centre d'Imagerie et Laser

Paris, , France

Site Status

Rothschild Foundation

Paris, , France

Site Status

Hopital Lariboisiere, Service Pharmacie

Paris, , France

Site Status

Centre Ophtalmologique Saint Exupéry

Saint-Cyr-sur-Loire, , France

Site Status

Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Site Status

Universitätsklinik für Augenheilkunde, Medizinische Hochschule Hannover

Hanover, , Germany

Site Status

Augenklinik der Ludwig-Maximilian Universität München

München, , Germany

Site Status

Eye Clinic Ludwig Maximilian

München, , Germany

Site Status

Augenzentrum am St. Franziskus-Hospital

Münster, , Germany

Site Status

Dept. of Ophthalmology Semmelweis University Budapest

Budapest, , Hungary

Site Status

Bajcsy Zsilinszky Korhaz Szemeszet

Budapest, , Hungary

Site Status

Budapest Retina Associates

Budapest, , Hungary

Site Status

Barzilai Medical Center

Ashkelon, , Israel

Site Status

Carmel Medical Center

Haifa, , Israel

Site Status

Kaplan Medical Center

Rehovot, , Israel

Site Status

Shamir Medical Center

Tzrifin, , Israel

Site Status

AOU Policlinico S. Orsola-Malpighi

Bologna, , Italy

Site Status

Clinica Oftalmologica Ospedale C. S.S. Annunziata

Chieti, , Italy

Site Status

Ospedaliero Universitaria di Ferrara

Ferrara, , Italy

Site Status

Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

Ospedale San Raffaele

Milan, , Italy

Site Status

Azienda Ospedaliera Fatebenefratelli

Milan, , Italy

Site Status

Azienda Ospedaliera U. della Campania "Vanvitelli"

Napoli, , Italy

Site Status

Policlinico Tor Vergata

Roma, , Italy

Site Status

Azienda Ospedaliero-U.Ospedali Riuniti Umberto I

Torrette Di Ancona, , Italy

Site Status

P. Stradins Clinical university hospital

Riga, , Latvia

Site Status

Hospital Universitario Puerta de Hierro-Majadahonda

Majadahonda, Madrid, Spain

Site Status

Clinicade Oftalmologia Barraquer

Barcelona, , Spain

Site Status

Institut Catala de la Retina

Barcelona, , Spain

Site Status

Instituto Clinico Quirurgico de Oftalmologia

Bilbao, , Spain

Site Status

Hospital La Arruzafa

Córdoba, , Spain

Site Status

Valles Ophthalmology Research (VOR) in Hospital General de Catalunya Pedro

Sant Cugat del Vallès, , Spain

Site Status

Instituto Oftalmológico Gómez-Ulla

Santiago de Compostela, , Spain

Site Status

IMED Servicio Oftalmología

Valencia, , Spain

Site Status

Rio Hortega University Hospital

Valladolid, , Spain

Site Status

Hospital Clínico Universitario "Lozano Blesa"

Zaragoza, , Spain

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada Colombia Croatia Czechia France Germany Hungary Israel Italy Latvia Spain

Other Identifiers

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2022-002860-59

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-515185-13-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

ISEE2009

Identifier Type: -

Identifier Source: org_study_id

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