Clinical trial NCT04435366: A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Official title: A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Geographic Atrophy
Macular Degeneration
Keywords: Geographic Atrophy (GA)
Age-related Macular Degeneration
AMD
Complement C5 inhibitor
avacincaptad pegol
IZERVAY
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2020-06-17
Enrollment: 448
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)

Detailed description: Participants were 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 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

Eligibility criteria: 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

Primary outcomes:
measure: The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12
timeFrame: Baseline to month 12
measure: The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24
timeFrame: Baseline to month 24
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months
timeFrame: Baseline and month 24
measure: Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months
timeFrame: Baseline and month 24
measure: Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months
timeFrame: Baseline, months 6, 12, and 18
measure: Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months
timeFrame: Baseline and month 24
measure: Number of Participants With Categorical One-level Loss in VFQ-25 Subscale
timeFrame: Baseline up to month 24
measure: Time to Persistent Vision Loss
timeFrame: Baseline up to month 24
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
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: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute/David Geffen School of Medicine
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Oxnard
country: United States
facility: California Retina Consultants
state: California
city: Palm Desert
country: United States
facility: Southern California Desert Retina Consultants
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: Sacramento
country: United States
facility: Retinal Consultants Medical Group, Inc.
state: California
city: Santa Ana
country: United States
facility: Orange County Retinal Medical 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 Colorado, P.C.
state: Colorado
city: Lakewood
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Danbury
country: United States
facility: Connecticut Eye Consultants, P.C.
state: Connecticut
city: Waterford
country: United States
facility: Retina Group of New England, PC
state: Connecticut
city: Altamonte Springs
country: United States
facility: Florida Eye Clinic
state: Florida
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: Fort Myers
country: United States
facility: Retina Health Center
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Gainesville
country: United States
facility: VitreoRetinal Associates, P.A.
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Miami
country: United States
facility: University of Miami-Bascom Palmer Eye Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Retina Care Specialists
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
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, PL
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macula Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina, P.C.
state: Georgia
city: 'Aiea
country: United States
facility: Retina Consultants of Hawaii, Inc
state: Hawaii
city: Lemont
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Lenexa
country: United States
facility: Retina Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Vitreo Retinal Consultants & Surgeons
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
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 Retinal Consultants
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Eye Center
state: Massachusetts
city: Worcester
country: United States
facility: Vitreoretinal Associates, PC
state: Massachusetts
city: Royal Oak
country: United States
facility: Associated Retinal Consultants, P.C.
state: Michigan
city: Minneapolis
country: United States
facility: Retina Center
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Henderson
country: United States
facility: Retina Consultants of Nevada
state: Nevada
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Retina Center of New Jersey, LLC
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultant
state: New York
city: Liverpool
country: United States
facility: Retina Vitreous Surgeons of Central New York, PC
state: New York
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York (VRMNY)
state: New York
city: Oceanside
country: United States
facility: OCLI
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western NY, PC
state: New York
city: Troy
country: United States
facility: Ophthalmic Consultants of the Capital Region
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Ashland
country: United States
facility: Retina and Vitreous Center of Southern Oregon
state: Oregon
city: Portland
country: United States
facility: Retina Northwest, PC
state: Oregon
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Scheie Eye Institute, University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: West Mifflin
country: United States
facility: Associates in Ophthalmology, Ltd
state: Pennsylvania
city: Beaufort
country: United States
facility: Retina Research of Beaufort, LLC
state: South Carolina
city: Ladson
country: United States
facility: Charleston Neuroscience Institute
state: South Carolina
city: Mount Pleasant
country: United States
facility: Carolina Macula and Retina
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: Johnson City
country: United States
facility: Southeastern Retina Associates, PC
state: Tennessee
city: Knoxville
country: United States
facility: Southeastern Retina Associates, PC
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
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: Houston
country: United States
facility: Retina and Vitreous of Texas, PLLC
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retinal Consultants of Houston
state: Texas
city: Willow Park
country: United States
facility: Strategic Clinical Research Group
state: Texas
city: Salt Lake City
country: United States
facility: Retinal Associates of Utah
state: Utah
city: Salt Lake City
country: United States
facility: Rocky Mountain Retina Consultants
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah, John A. Moran Eye Center
state: Utah
city: Norfolk
country: United States
facility: Wagner Macular & Retina Center
state: Virginia
city: Richmond
country: United States
facility: Retina Institute of Virginia
state: Virginia
city: Roanoke
country: United States
facility: Vistar Eye Center
state: Virginia
city: Bellevue
country: United States
facility: Pacific Northwest Retina
state: Washington
city: Silverdale
country: United States
facility: Retina Center NW, PLLC
state: Washington
city: Buenos Aires
country: Argentina
facility: Centro Oftalmológico Dr. Charles SA
state: Caba
city: Buenos Aires
country: Argentina
facility: Buenos Aires Macula S.A.
state: Caba
city: Rosario
country: Argentina
facility: Centro Médico Grupo Laser Visión
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto Oftalmológico de Buenos Aires
city: Córdoba
country: Argentina
facility: Centro Privado de Ojos Romagosa S.A.
city: Córdoba
country: Argentina
facility: Instituto Oftalmológico de Córdoba
city: Mendoza
country: Argentina
facility: Centro Privado de Oftalmologia - OFTAR Mendoza SRL
city: Rosario
country: Argentina
facility: Centro Medico Micro Diagnostico y Microcirugla Ocular
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: East Melbourne
country: Australia
facility: Royal Victorian Eye & Ear Hospital
city: Graz
country: Austria
facility: Medizinische Universitaet Graz - Augenklinik
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: Hanush Hospital
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Belo Horizonte
country: Brazil
facility: Centro de Ensino e Pesquisa do Instituto da Visao (CEPIV)
city: São Paulo
country: Brazil
facility: IPEPO - Instituto da visão
city: Vila Clementino
country: Brazil
facility: Hospital Sao Paulo - UNIFESP
city: Calgary
country: Canada
facility: Calgary Retina Consultants
state: Alberta
city: Vancouver
country: Canada
facility: UBC/VGH Eye Care Center
state: British Columbia
city: London
country: Canada
facility: St.Joseph's Health Care London
state: Ontario
city: Mississauga
country: Canada
facility: Canadian Centre for Advanced Eye Therapeutics Inc.
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Ottawa
country: Canada
facility: Retina Centre of Ottawa
city: Medellín
country: Colombia
facility: Clinica De Oftalmologia Sandiego
state: Antioquia
city: Bogotá
country: Colombia
facility: Fundacion OJlalmologica Nacional - FUNDONAL
city: Osijek
country: Croatia
facility: Clinical hospital Center Osijek
city: Prague
country: Czechia
facility: Axon Clinical s.r.o.
state: Smichov
city: Tallin
country: Estonia
facility: Dr Kai Noor Silmakabinet
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hopital Pellegrin
city: Créteil
country: France
facility: Hopital Intercommunal
city: Dijon
country: France
facility: CHU Bocage
city: Lyon
country: France
facility: Centre d'ophtalmologie Rabelais
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Marseille
country: France
facility: Centre Paradis Monticelli
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Centre d'exploration ophtalmologique de l'Odeon
city: Paris
country: France
facility: Hôpital Lariboisière
city: Paris
country: France
facility: Centre Ophtalmologique d'Imagerie et de Laser
city: Paris
country: France
facility: Fondation Alolphe de Rotschild
city: Saint-Cyr-sur-Loire
country: France
facility: Centre St Exupery
city: Écully
country: France
facility: Centre Pole Vision Val d'Ouest
city: Aachen
country: Germany
facility: RWTH Aachen University
city: Bonn
country: Germany
facility: University of Bonn
city: Göttingen
country: Germany
facility: University of Göttingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum
city: Hanover
country: Germany
facility: University Eye Hospital, MHH
city: Köln
country: Germany
facility: Augenklinik University Hospital Cologne
city: Leipzig
country: Germany
facility: University clinic Leipzig AÖR
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Munich
country: Germany
facility: Ludwig-Maximilians-University Munich
city: Munich
country: Germany
facility: Clinic Rechts der Isar
city: Münster
country: Germany
facility: Augenzentrum am St. Franziskus-Hospital
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Tübingen
country: Germany
facility: Universitäts-Augenklinik
city: Budapest
country: Hungary
facility: Hungarian Military Hospital Center
city: Budapest
country: Hungary
facility: Bajcsy Zsilinszky Kórház - Szemészet
city: Budapest
country: Hungary
facility: Budapest Retina Associates
city: Budapest
country: Hungary
facility: Semmelweis University, Dept of Ophthalmology
city: Debrecen
country: Hungary
facility: Debrecen University Clinical Center, Dept of Ophthalmology
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital
city: Pécs
country: Hungary
facility: Ganglion Medical Center
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Be'er Ya'aqov
country: Israel
facility: Shamir Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Centre
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
city: Petah tikva
country: Israel
facility: Department of Ophthalmology, Rabin Medical Center
city: Reẖovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Ancona
country: Italy
facility: Ospedali Riuniti di Ancona
city: Bologna
country: Italy
facility: A.O.U. Policlinico Sant'Orsola-Malpighi
city: Chieti
country: Italy
facility: Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"
city: Ferrara
country: Italy
facility: Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)
city: Florence
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Milan
country: Italy
facility: Ospedale Maggiore Policlinico Milano
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Milan
country: Italy
facility: Ospedale Luigi Sacco
city: Naples
country: Italy
facility: AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica
city: Pisa
country: Italy
facility: University of Pisa
city: Roma
country: Italy
facility: Fondazione PTV
city: Roma
country: Italy
facility: Fondazione GB Bietti IRCCS
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Integrata
city: Riga
country: Latvia
facility: Pauls Stradinis Clinical University Hospital
city: Bydgoszcz
country: Poland
facility: Klinika Okulistyczna OFT ALMIKA Sp. z o. o.
city: Tarnowskie Góry
country: Poland
facility: Caminomed
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
city: Łódź
country: Poland
facility: Medical Center Julianów
city: Barcelona
country: Spain
facility: Clinica de Oftalmologia Barraquer
city: Barcelona
country: Spain
facility: Institut Catala de Retina
city: Barcelona
country: Spain
facility: Institut de la Macula
city: Barcelona
country: Spain
facility: VOR - Hospital General de Catalunya
city: Bilbao
country: Spain
facility: Instituto Clinico Quirurgico de Oftalmologia
city: Córdoba
country: Spain
facility: Hospital La Arruzafa
city: Majadahonda
country: Spain
facility: H.U. Puerta de Hierro-Majadahonda
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Santiago De Compostela
country: Spain
facility: Instituto Oftalmologico Gomez-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"
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
Study officials:
References: