A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
NCT ID: NCT04435366
Last Updated: 2025-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
448 participants
INTERVENTIONAL
2020-06-22
2023-08-22
Brief Summary
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Detailed Description
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* Avacincaptad pegol 2 mg
* Sham
At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis
The participants initially randomized to sham treatment continued with monthly sham administration through Month 23
All participants had a final follow up visit at Month 24
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Avacincaptad Pegol
Participants received avacincaptad pegol (ACP) 2 milligram (mg)/eye via intravitreal (IVT) injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly from month12 through month 23 (Year 2).
Avacincaptad Pegol
Avacincaptad Pegol Intravitreal Injection
Sham
Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham administration from month 12 through month 23 (Year 2).
Sham
Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection)
Avacincaptad pegol and Sham
Participants who received ACP 2mg monthly through Month 11 (Year 1) were re-randomized at month 12, to receive ACP 2 mg/eye via IVT injections every other month at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22.
Avacincaptad Pegol
Avacincaptad Pegol Intravitreal Injection
Interventions
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Avacincaptad Pegol
Avacincaptad Pegol Intravitreal Injection
Sham
Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion Criteria
* Any intraocular surgery or thermal laser within 3 months of trial entry.
* Any prior thermal laser in the macular region, regardless of indication
* Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.
* Previous therapeutic radiation in the region of the study eye
* Any sign of diabetic retinopathy in either eye
50 Years
ALL
No
Sponsors
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IVERIC bio, Inc.
INDUSTRY
Responsible Party
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Locations
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Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Retinal Diagnostic Center
Campbell, California, United States
Eye Medical Center of Fresno
Fresno, California, United States
Retina Consultants of Orange County
Fullerton, California, United States
University of California, San Diego
La Jolla, California, United States
Jules Stein Eye Institute/David Geffen School of Medicine
Los Angeles, California, United States
Northern California Retina Vitreous Associates
Mountain View, California, United States
California Retina Consultants
Oxnard, California, United States
Southern California Desert Retina Consultants
Palm Desert, California, United States
Doheny Eye Center, UCLA
Pasadena, California, United States
Retina Consultants of Southern California
Redlands, California, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, United States
Orange County Retinal Medical Group
Santa Ana, California, United States
University of Colorado
Aurora, Colorado, United States
Retina Consultants of Southern Colorado, P.C.
Colorado Springs, Colorado, United States
Colorado Retina Associates
Lakewood, Colorado, United States
Connecticut Eye Consultants, P.C.
Danbury, Connecticut, United States
Retina Group of New England, PC
Waterford, Connecticut, United States
Florida Eye Clinic
Altamonte Springs, Florida, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Retina Health Center
Fort Myers, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
VitreoRetinal Associates, P.A.
Gainesville, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
University of Miami-Bascom Palmer Eye Institute
Miami, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Retina Specialty Institute
Pensacola, 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, PL
Tallahassee, Florida, United States
Center for Retina and Macula Disease
Winter Haven, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Georgia Retina, P.C.
Marietta, Georgia, United States
Retina Consultants of Hawaii, Inc
‘Aiea, Hawaii, United States
University Retina and Macula Associates, PC
Lemont, Illinois, United States
Illinois Eye Center
Peoria, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Retina Associates, LLC
Lenexa, Kansas, United States
Vitreo Retinal Consultants & Surgeons
Wichita, Kansas, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
The Retina Care Center
Baltimore, Maryland, United States
The Retina Group of Washington
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Retina Research Institute at New England Retinal Consultants
Springfield, Massachusetts, United States
UMASS Memorial Eye Center
Worcester, Massachusetts, United States
Vitreoretinal Associates, PC
Worcester, Massachusetts, United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States
Retina Center
Minneapolis, Minnesota, United States
St. Louis University
St Louis, Missouri, United States
Retina Consultants of Nevada
Henderson, Nevada, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina Center of New Jersey, LLC
Bloomfield, New Jersey, United States
Long Island Vitreoretinal Consultant
Great Neck, New York, United States
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States
Vitreous Retina Macula Consultants of New York (VRMNY)
New York, New York, United States
OCLI
Oceanside, New York, United States
Retina Associates of Western NY, PC
Rochester, New York, United States
Ophthalmic Consultants of the Capital Region
Troy, New York, United States
Western Carolina Retinal Associates
Asheville, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Retina and Vitreous Center of Southern Oregon
Ashland, Oregon, United States
Retina Northwest, PC
Portland, Oregon, United States
EyeHealth Northwest
Portland, Oregon, United States
Casey Eye Institute
Portland, Oregon, United States
Scheie Eye Institute, University of Pennsylvania
Philadelphia, Pennsylvania, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Associates in Ophthalmology, Ltd
West Mifflin, Pennsylvania, United States
Retina Research of Beaufort, LLC
Beaufort, South Carolina, United States
Charleston Neuroscience Institute
Ladson, South Carolina, United States
Carolina Macula and Retina
Mt. Pleasant, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Southeastern Retina Associates, PC
Johnson City, Tennessee, United States
Southeastern Retina Associates, PC
Knoxville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Southwest Retina Specialists
Amarillo, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Retina and Vitreous of Texas, PLLC
Houston, Texas, United States
Valley Retina Institute
McAllen, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Retina Center of Texas
Southlake, Texas, United States
Retinal Consultants of Houston
The Woodlands, Texas, United States
Strategic Clinical Research Group
Willow Park, Texas, United States
Retinal Associates of Utah
Salt Lake City, Utah, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States
University of Utah, John A. Moran Eye Center
Salt Lake City, Utah, United States
Wagner Macular & Retina Center
Norfolk, Virginia, United States
Retina Institute of Virginia
Richmond, Virginia, United States
Vistar Eye Center
Roanoke, Virginia, United States
Pacific Northwest Retina
Bellevue, Washington, United States
Retina Center NW, PLLC
Silverdale, Washington, United States
Centro Oftalmológico Dr. Charles SA
Buenos Aires, Buenos Aires F.D., Argentina
Buenos Aires Macula S.A.
Buenos Aires, Buenos Aires F.D., Argentina
Centro Médico Grupo Laser Visión
Rosario, Santa Fe Province, Argentina
Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"
Rosario, Santa Fe Province, Argentina
Instituto Oftalmológico de Buenos Aires
Buenos Aires, , Argentina
Centro Privado de Ojos Romagosa S.A.
Córdoba, , Argentina
Instituto Oftalmológico de Córdoba
Córdoba, , Argentina
Centro Privado de Oftalmologia - OFTAR Mendoza SRL
Mendoza, , Argentina
Centro Medico Micro Diagnostico y Microcirugla Ocular
Rosario, , Argentina
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Royal Victorian Eye & Ear Hospital
East Melbourne, , Australia
Medizinische Universitaet Graz - Augenklinik
Graz, , Austria
Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie
Innsbruck, , Austria
Medical University of Vienna
Vienna, , Austria
Hanush Hospital
Vienna, , Austria
CHU Brugmann
Brussels, , Belgium
Centro de Ensino e Pesquisa do Instituto da Visao (CEPIV)
Belo Horizonte, , Brazil
IPEPO - Instituto da visão
São Paulo, , Brazil
Hospital Sao Paulo - UNIFESP
Vila Clementino, , Brazil
Calgary Retina Consultants
Calgary, Alberta, Canada
UBC/VGH Eye Care Center
Vancouver, British Columbia, Canada
St.Joseph's Health Care London
London, Ontario, Canada
Canadian Centre for Advanced Eye Therapeutics Inc.
Mississauga, Ontario, Canada
University of Ottawa Eye Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Retina Centre of Ottawa
Ottawa, , Canada
Clinica De Oftalmologia Sandiego
Medellín, Antioquia, Colombia
Fundacion OJlalmologica Nacional - FUNDONAL
Bogotá, , Colombia
Clinical hospital Center Osijek
Osijek, , Croatia
Axon Clinical s.r.o.
Prague, Smichov, Czechia
Dr Kai Noor Silmakabinet
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, , France
Hopital Intercommunal
Créteil, , France
CHU Bocage
Dijon, , France
Centre Pole Vision Val d'Ouest
Écully, , France
Centre d'ophtalmologie Rabelais
Lyon, , France
Hopital de la Croix Rousse
Lyon, , France
Centre Paradis Monticelli
Marseille, , France
CHU de Nantes
Nantes, , France
Centre d'exploration ophtalmologique de l'Odeon
Paris, , France
Hôpital Lariboisière
Paris, , France
Centre Ophtalmologique d'Imagerie et de Laser
Paris, , France
Fondation Alolphe de Rotschild
Paris, , France
Centre St Exupery
Saint-Cyr-sur-Loire, , France
RWTH Aachen University
Aachen, , Germany
University of Bonn
Bonn, , Germany
Augenklinik University Hospital Cologne
Cologne, , Germany
University of Göttingen
Göttingen, , Germany
Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum
Hamburg, , Germany
University Eye Hospital, MHH
Hanover, , Germany
University clinic Leipzig AÖR
Leipzig, , Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Ludwig-Maximilians-University Munich
Munich, , Germany
Clinic Rechts der Isar
Munich, , Germany
Augenzentrum am St. Franziskus-Hospital
Münster, , Germany
Universitätsklinikum Münster
Münster, , Germany
Universitäts-Augenklinik
Tübingen, , Germany
Hungarian Military Hospital Center
Budapest, , Hungary
Bajcsy Zsilinszky Kórház - Szemészet
Budapest, , Hungary
Budapest Retina Associates
Budapest, , Hungary
Semmelweis University, Dept of Ophthalmology
Budapest, , Hungary
Debrecen University Clinical Center, Dept of Ophthalmology
Debrecen, , Hungary
Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital
Nyíregyháza, , Hungary
Ganglion Medical Center
Pécs, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Shamir Medical Center
Be’er Ya‘aqov, , Israel
Rambam Medical Centre
Haifa, , Israel
Carmel Medical Center
Haifa, , Israel
Edith Wolfson Medical Center
Holon, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Department of Ophthalmology, Rabin Medical Center
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Ospedali Riuniti di Ancona
Ancona, , Italy
A.O.U. Policlinico Sant'Orsola-Malpighi
Bologna, , Italy
Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"
Chieti, , Italy
Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)
Ferrara, , Italy
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Ospedale Maggiore Policlinico Milano
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Ospedale Luigi Sacco
Milan, , Italy
AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica
Naples, , Italy
Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica
Padua, , Italy
University of Pisa
Pisa, , Italy
Fondazione PTV
Roma, , Italy
Fondazione GB Bietti IRCCS
Roma, , Italy
Azienda Sanitaria Universitaria Integrata
Udine, , Italy
Pauls Stradinis Clinical University Hospital
Riga, , Latvia
Klinika Okulistyczna OFT ALMIKA Sp. z o. o.
Bydgoszcz, , Poland
Medical Center Julianów
Lodz, , Poland
Caminomed
Tarnowskie Góry, , Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
Wroclaw, , Poland
Clinica de Oftalmologia Barraquer
Barcelona, , Spain
Institut Catala de Retina
Barcelona, , Spain
Institut de la Macula
Barcelona, , Spain
VOR - Hospital General de Catalunya
Barcelona, , Spain
Instituto Clinico Quirurgico de Oftalmologia
Bilbao, , Spain
Hospital La Arruzafa
Córdoba, , Spain
H.U. Puerta de Hierro-Majadahonda
Majadahonda, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Instituto Oftalmologico Gomez-Ulla
Santiago de Compostela, , Spain
IMED Servicio Oftalmología
Valencia, , Spain
Rio Hortega University Hospital
Valladolid, , Spain
Hospital Clínico Universitario "Lozano Blesa"
Zaragoza, , Spain
Hull University Teaching Hospitals NHS Trust
Hull, , United Kingdom
Countries
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References
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Khanani AM, Patel SS, Staurenghi G, Tadayoni R, Danzig CJ, Eichenbaum DA, Hsu J, Wykoff CC, Heier JS, Lally DR, Mones J, Nielsen JS, Sheth VS, Kaiser PK, Clark J, Zhu L, Patel H, Tang J, Desai D, Jaffe GJ; GATHER2 trial investigators. Efficacy and safety of avacincaptad pegol in patients with geographic atrophy (GATHER2): 12-month results from a randomised, double-masked, phase 3 trial. Lancet. 2023 Oct 21;402(10411):1449-1458. doi: 10.1016/S0140-6736(23)01583-0. Epub 2023 Sep 8.
Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to results and other applicable study documents on the Astellas Clinical Trials website.
Link to plain language summary of the study on the Trial Results Summaries website.
Other Identifiers
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ISEE2008
Identifier Type: -
Identifier Source: org_study_id
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