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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04435366
Other study ID # ISEE2008
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 22, 2020
Est. completion date August 22, 2023

Study information

Verified date November 2023
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objectives of this study are to evaluate the safety and efficacy of Zimura (avacincaptad pegol) intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)


Description:

Participants will be randomized in a 1:1 ratio to the following monthly treatment groups: - Avacincaptad pegol 2 mg - Sham At Month 12, the participants in the avacincaptad pegol 2mg treatment group will be 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 will continue with monthly sham administration through Month 23 All participants will have a final follow up visit at Month 24


Recruitment information / eligibility

Status Completed
Enrollment 448
Est. completion date August 22, 2023
Est. primary completion date July 25, 2022
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Subjects of either gender aged = 50 years - Diagnosis of Non-foveal GA secondary to dry AMD Exclusion Criteria: - Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals - 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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)

Locations

Country Name City State
Argentina Buenos Aires Macula S.A. Buenos Aires Caba
Argentina Centro Oftalmológico Dr. Charles SA Buenos Aires Caba
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 de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas" Rosario Santa Fe
Argentina Centro Médico Grupo Laser Visión Rosario Santa Fe
Argentina Centro Medico Micro Diagnostico y Microcirugla Ocular Rosario
Australia Royal Victorian Eye & Ear Hospital East Melbourne
Australia Sydney Eye Hospital Sydney New South Wales
Australia Sydney Retina Clinic and Day Surgery Sydney New South Wales
Austria Medizinische Universitaet Graz - Augenklinik Graz
Austria Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie Innsbruck
Austria Hanush Hospital Vienna
Austria Medical University of Vienna Vienna
Belgium CHU Brugmann Brussels
Brazil 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
Canada Calgary Retina Consultants Calgary Alberta
Canada St.Joseph's Health Care London London Ontario
Canada Canadian Centre for Advanced Eye Therapeutics Inc. Mississauga Ontario
Canada Retina Centre of Ottawa Ottawa
Canada University of Ottawa Eye Institute Ottawa Ontario
Canada University Health Network Toronto Ontario
Canada UBC/VGH Eye Care Center Vancouver British Columbia
Colombia Fundacion OJlalmologica Nacional - FUNDONAL Bogotá
Colombia Clinica De Oftalmologia Sandiego Medellín Antioquia
Croatia Clinical hospital Center Osijek Osijek
Czechia Axon Clinical s.r.o. Prague Smichov
Estonia Dr Kai Noor Silmakabinet Tallin
Estonia Tartu University Hospital Tartu
France 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 Centre Ophtalmologique d'Imagerie et de Laser Paris
France Fondation Alolphe de Rotschild Paris
France Hôpital Lariboisière Paris
France Centre St Exupery Saint-Cyr-sur-Loire
Germany RWTH Aachen University Aachen
Germany University of Bonn Bonn
Germany University of Göttingen Göttingen
Germany Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum Hamburg
Germany University Eye Hospital, MHH Hanover
Germany Augenklinik University Hospital Cologne Köln
Germany University clinic Leipzig AÖR Leipzig
Germany Universitätsklinikum Schleswig-Holstein Lübeck
Germany Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz
Germany Clinic Rechts der Isar Munich
Germany Ludwig-Maximilians-University Munich Munich
Germany Augenzentrum am St. Franziskus-Hospital Münster
Germany Universitätsklinikum Münster Münster
Germany Universitäts-Augenklinik Tübingen
Hungary Bajcsy Zsilinszky Kórház - Szemészet Budapest
Hungary Budapest Retina Associates Budapest
Hungary Hungarian Military Hospital Center 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 Nyiregyhaza
Hungary Ganglion Medical Center Pécs
Hungary Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Szeged
Israel Barzilai Medical Center Ashkelon
Israel Shamir Medical Center Be'er Ya'aqov
Israel Carmel Medical Center Haifa
Israel Rambam Medical Centre 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 Re?ovot
Israel Sourasky Medical Center Tel Aviv
Italy 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 IRCCS Ospedale San Raffaele Milan
Italy Ospedale Luigi Sacco Milan
Italy Ospedale Maggiore Policlinico Milano Milan
Italy AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica Naples
Italy Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica Padova
Italy University of Pisa Pisa
Italy Fondazione GB Bietti IRCCS Roma
Italy Fondazione PTV Roma
Italy Azienda Sanitaria Universitaria Integrata Udine
Latvia Pauls Stradinis Clinical University Hospital Riga
Poland Klinika Okulistyczna OFT ALMIKA Sp. z o. o. Bydgoszcz
Poland Medical Center Julianów Lódz
Poland Caminomed Tarnowskie Góry
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego Wroclaw
Spain 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
United Kingdom Hull University Teaching Hospitals NHS Trust Hull
United States Retina Consultants of Hawaii, Inc 'Aiea Hawaii
United States Retina Research Institute of Texas Abilene Texas
United States Florida Eye Clinic Altamonte Springs Florida
United States Southwest Retina Specialists Amarillo Texas
United States Western Carolina Retinal Associates Asheville North Carolina
United States Retina and Vitreous Center of Southern Oregon Ashland Oregon
United States Southeast Retina Center Augusta Georgia
United States University of Colorado Aurora Colorado
United States Austin Retina Associates Austin Texas
United States The Retina Care Center Baltimore Maryland
United States Retina Research of Beaufort, LLC Beaufort South Carolina
United States Pacific Northwest Retina Bellevue Washington
United States Retina-Vitreous Associates Medical Group Beverly Hills California
United States Retina Center of New Jersey, LLC Bloomfield New Jersey
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States Retinal Diagnostic Center Campbell California
United States The Retina Group of Washington Chevy Chase Maryland
United States Cincinnati Eye Institute Cincinnati Ohio
United States Retina Consultants of Southern Colorado, P.C. Colorado Springs Colorado
United States Retina Foundation of the Southwest Dallas Texas
United States Connecticut Eye Consultants, P.C. Danbury Connecticut
United States Rand Eye Institute Deerfield Beach Florida
United States Retina Group of Florida Fort Lauderdale Florida
United States National Ophthalmic Research Institute Fort Myers Florida
United States Retina Health Center Fort Myers Florida
United States Eye Medical Center of Fresno Fresno California
United States Retina Consultants of Orange County Fullerton California
United States VitreoRetinal Associates, P.A. Gainesville Florida
United States Long Island Vitreoretinal Consultant Great Neck New York
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Retina Consultants of Nevada Henderson Nevada
United States Retina and Vitreous of Texas, PLLC Houston Texas
United States Midwest Eye Institute Indianapolis Indiana
United States Southeastern Retina Associates, PC Johnson City Tennessee
United States Southeastern Retina Associates, PC Knoxville Tennessee
United States University of California, San Diego La Jolla California
United States Charleston Neuroscience Institute Ladson South Carolina
United States Colorado Retina Associates Lakewood Colorado
United States University Retina and Macula Associates, PC Lemont Illinois
United States Retina Associates, LLC Lenexa Kansas
United States Retina Vitreous Surgeons of Central New York, PC Liverpool New York
United States Jules Stein Eye Institute/David Geffen School of Medicine Los Angeles California
United States Georgia Retina, P.C. Marietta Georgia
United States Valley Retina Institute McAllen Texas
United States Florida Eye Associates Melbourne Florida
United States University of Miami-Bascom Palmer Eye Institute Miami Florida
United States Retina Center Minneapolis Minnesota
United States Carolina Macula and Retina Mount Pleasant South Carolina
United States Northern California Retina Vitreous Associates Mountain View California
United States Ochsner Medical Center New Orleans Louisiana
United States Vitreous Retina Macula Consultants of New York (VRMNY) New York New York
United States Wagner Macular & Retina Center Norfolk Virginia
United States OCLI Oceanside New York
United States California Retina Consultants Oxnard California
United States Retina Care Specialists Palm Beach Gardens Florida
United States Southern California Desert Retina Consultants Palm Desert California
United States Doheny Eye Center, UCLA Pasadena California
United States Retina Specialty Institute Pensacola Florida
United States Illinois Eye Center Peoria Illinois
United States Mid Atlantic Retina Philadelphia Pennsylvania
United States Scheie Eye Institute, University of Pennsylvania Philadelphia Pennsylvania
United States Casey Eye Institute Portland Oregon
United States EyeHealth Northwest Portland Oregon
United States Retina Northwest, PC Portland Oregon
United States Black Hills Regional Eye Institute Rapid City South Dakota
United States Retina Consultants of Southern California Redlands California
United States Sierra Eye Associates Reno Nevada
United States Retina Institute of Virginia Richmond Virginia
United States Vistar Eye Center Roanoke Virginia
United States Retina Associates of Western NY, PC Rochester New York
United States Associated Retinal Consultants, P.C. Royal Oak Michigan
United States Retinal Consultants Medical Group, Inc. Sacramento California
United States St. Louis University Saint Louis Missouri
United States Retina Vitreous Associates of Florida Saint Petersburg Florida
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 Medical Center Ophthalmology Associates San Antonio Texas
United States Orange County Retinal Medical Group Santa Ana California
United States Retina Associates of Sarasota Sarasota Florida
United States Retina Center NW, PLLC Silverdale Washington
United States Retina Center of Texas Southlake Texas
United States Retina Research Institute at New England Retinal Consultants Springfield Massachusetts
United States East Florida Eye Institute Stuart Florida
United States Southern Vitreoretinal Associates, PL Tallahassee Florida
United States Retinal Consultants of Houston The Woodlands Texas
United States Ophthalmic Consultants of the Capital Region Troy New York
United States Retina Group of New England, PC Waterford Connecticut
United States Palmetto Retina Center West Columbia South Carolina
United States Wolfe Eye Clinic West Des Moines Iowa
United States Associates in Ophthalmology, Ltd West Mifflin Pennsylvania
United States Vitreo Retinal Consultants & Surgeons Wichita Kansas
United States Strategic Clinical Research Group Willow Park Texas
United States Center for Retina and Macula Disease Winter Haven Florida
United States UMASS Memorial Eye Center Worcester Massachusetts
United States Vitreoretinal Associates, PC Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
IVERIC bio, Inc.

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Rate of Change in GA Over 12 Months (Measured at Three Time Points: Baseline, Month 6, and Month 12) The least squares mean rate of growth (slope) estimated based on geographic atrophy (GA) area measured by fundus autofluorescence (FAF) in at least 3 timepoints: Baseline, Month 6, and Month 12 was used to determine mean rate of change (slope) in GA from Baseline to Month 12. The square root of the GA area was used in the analysis. Baseline and Month 12
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