A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Geographic Atrophy, Macular Degeneration
About this trial
This is an interventional treatment trial for Geographic Atrophy focused on measuring Geographic Atrophy (GA), Age-related Macular Degeneration, AMD, Zimura, Complement C5 inhibitor, avacincaptad pegol, IZERVAY
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
Sites / Locations
- Retina-Vitreous Associates Medical Group
- Retinal Diagnostic Center
- Eye Medical Center of Fresno
- Retina Consultants of Orange County
- University of California, San Diego
- Jules Stein Eye Institute/David Geffen School of Medicine
- Northern California Retina Vitreous Associates
- California Retina Consultants
- Southern California Desert Retina Consultants
- Doheny Eye Center, UCLA
- Retina Consultants of Southern California
- Retinal Consultants Medical Group, Inc.
- Orange County Retinal Medical Group
- University of Colorado
- Retina Consultants of Southern Colorado, P.C.
- Colorado Retina Associates
- Connecticut Eye Consultants, P.C.
- Retina Group of New England, PC
- Florida Eye Clinic
- Rand Eye Institute
- Retina Group of Florida
- Retina Health Center
- National Ophthalmic Research Institute
- VitreoRetinal Associates, P.A.
- Florida Eye Associates
- University of Miami-Bascom Palmer Eye Institute
- Retina Care Specialists
- Retina Specialty Institute
- Retina Vitreous Associates of Florida
- Retina Associates of Sarasota
- East Florida Eye Institute
- Southern Vitreoretinal Associates, PL
- Center for Retina and Macula Disease
- Southeast Retina Center
- Georgia Retina, P.C.
- Retina Consultants of Hawaii, Inc
- University Retina and Macula Associates, PC
- Illinois Eye Center
- Midwest Eye Institute
- Wolfe Eye Clinic
- Retina Associates, LLC
- Vitreo Retinal Consultants & Surgeons
- Ochsner Medical Center
- The Retina Care Center
- The Retina Group of Washington
- Cumberland Valley Retina Consultants
- Ophthalmic Consultants of Boston
- Retina Research Institute at New England Retinal Consultants
- UMASS Memorial Eye Center
- Vitreoretinal Associates, PC
- Associated Retinal Consultants, P.C.
- Retina Center
- St. Louis University
- Retina Consultants of Nevada
- Sierra Eye Associates
- Retina Center of New Jersey, LLC
- Long Island Vitreoretinal Consultant
- Retina Vitreous Surgeons of Central New York, PC
- Vitreous Retina Macula Consultants of New York (VRMNY)
- OCLI
- Retina Associates of Western NY, PC
- Ophthalmic Consultants of the Capital Region
- Western Carolina Retinal Associates
- Cincinnati Eye Institute
- Retina and Vitreous Center of Southern Oregon
- Retina Northwest, PC
- EyeHealth Northwest
- Casey Eye Institute
- Scheie Eye Institute, University of Pennsylvania
- Mid Atlantic Retina
- Associates in Ophthalmology, Ltd
- Retina Research of Beaufort, LLC
- Charleston Neuroscience Institute
- Carolina Macula and Retina
- Palmetto Retina Center
- Black Hills Regional Eye Institute
- Southeastern Retina Associates, PC
- Southeastern Retina Associates, PC
- Retina Research Institute of Texas
- Southwest Retina Specialists
- Austin Retina Associates
- Retina Foundation of the Southwest
- Retina and Vitreous of Texas, PLLC
- Valley Retina Institute
- Medical Center Ophthalmology Associates
- Retina Center of Texas
- Retinal Consultants of Houston
- Strategic Clinical Research Group
- Retinal Associates of Utah
- Rocky Mountain Retina Consultants
- University of Utah, John A. Moran Eye Center
- Wagner Macular & Retina Center
- Retina Institute of Virginia
- Vistar Eye Center
- Pacific Northwest Retina
- Retina Center NW, PLLC
- Centro Oftalmológico Dr. Charles SA
- Buenos Aires Macula S.A.
- Centro Médico Grupo Laser Visión
- Centro de Diagnóstico y Cirugía Ocular "Oftalmólogos Especialistas"
- Instituto Oftalmológico de Buenos Aires
- Centro Privado de Ojos Romagosa S.A.
- Instituto Oftalmológico de Córdoba
- Centro Privado de Oftalmologia - OFTAR Mendoza SRL
- Centro Medico Micro Diagnostico y Microcirugla Ocular
- Sydney Eye Hospital
- Sydney Retina Clinic and Day Surgery
- Royal Victorian Eye & Ear Hospital
- Medizinische Universitaet Graz - Augenklinik
- Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Augenheilkunde und Optometrie
- Medical University of Vienna
- Hanush Hospital
- CHU Brugmann
- Centro de Ensino e Pesquisa do Instituto da Visao (CEPIV)
- IPEPO - Instituto da visão
- Hospital Sao Paulo - UNIFESP
- Calgary Retina Consultants
- UBC/VGH Eye Care Center
- St.Joseph's Health Care London
- Canadian Centre for Advanced Eye Therapeutics Inc.
- University of Ottawa Eye Institute
- University Health Network
- Retina Centre of Ottawa
- Clinica De Oftalmologia Sandiego
- Fundacion OJlalmologica Nacional - FUNDONAL
- Clinical hospital Center Osijek
- Axon Clinical s.r.o.
- Dr Kai Noor Silmakabinet
- Tartu University Hospital
- CHU de Bordeaux - Hopital Pellegrin
- Hopital Intercommunal
- CHU Bocage
- Centre d'ophtalmologie Rabelais
- Hopital de la Croix Rousse
- Centre Paradis Monticelli
- CHU de Nantes
- Centre d'exploration ophtalmologique de l'Odeon
- Hôpital Lariboisière
- Centre Ophtalmologique d'Imagerie et de Laser
- Fondation Alolphe de Rotschild
- Centre St Exupery
- Centre Pole Vision Val d'Ouest
- RWTH Aachen University
- University of Bonn
- University of Göttingen
- Universitätsklinikum Hamburg Eppendorf Klinik und Poliklinik für Augenheilkunde Studienzentrum
- University Eye Hospital, MHH
- Augenklinik University Hospital Cologne
- University clinic Leipzig AÖR
- Universitätsklinikum Schleswig-Holstein
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Ludwig-Maximilians-University Munich
- Clinic Rechts der Isar
- Augenzentrum am St. Franziskus-Hospital
- Universitätsklinikum Münster
- Universitäts-Augenklinik
- Hungarian Military Hospital Center
- Bajcsy Zsilinszky Kórház - Szemészet
- Budapest Retina Associates
- Semmelweis University, Dept of Ophthalmology
- Debrecen University Clinical Center, Dept of Ophthalmology
- Szabolcs-Szatmar-Bereg County Hospital and University Teaching Hospital
- Ganglion Medical Center
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
- Barzilai Medical Center
- Shamir Medical Center
- Rambam Medical Centre
- Carmel Medical Center
- Edith Wolfson Medical Center
- Hadassah University Hospital
- Department of Ophthalmology, Rabin Medical Center
- Kaplan Medical Center
- Sourasky Medical Center
- Ospedali Riuniti di Ancona
- A.O.U. Policlinico Sant'Orsola-Malpighi
- Ospedale Clinicizzato Universita di Chieti "Ss Annunziata"
- Nuovo Arcispedale Sant' Anna (A.O.U. di Ferrara)
- Azienda Ospedaliera Universitaria Careggi
- Ospedale Maggiore Policlinico Milano
- IRCCS Ospedale San Raffaele
- Ospedale Luigi Sacco
- AOU Universita degli Studi della Campania Luigi Vanvitelli UOC Oculistica
- Azienda Ospedaliera di Padova Unità Operativa Complessa di Clinica Oculistica
- University of Pisa
- Fondazione PTV
- Fondazione GB Bietti IRCCS
- Azienda Sanitaria Universitaria Integrata
- Pauls Stradinis Clinical University Hospital
- Klinika Okulistyczna OFT ALMIKA Sp. z o. o.
- Caminomed
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
- Medical Center Julianów
- Clinica de Oftalmologia Barraquer
- Institut Catala de Retina
- Institut de la Macula
- VOR - Hospital General de Catalunya
- Instituto Clinico Quirurgico de Oftalmologia
- Hospital La Arruzafa
- H.U. Puerta de Hierro-Majadahonda
- Clinica Universidad de Navarra
- Instituto Oftalmologico Gomez-Ulla
- IMED Servicio Oftalmología
- Rio Hortega University Hospital
- Hospital Clínico Universitario "Lozano Blesa"
- Hull University Teaching Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Avacincaptad Pegol Treatment Group
Sham Treatment Group
Monthly avacincaptad pegol 2mg intravitreal injections through Month 11 (Year 1) NOTE: At Month 12, participants are re-randomized to receive monthly injections or every other month injections (alternating with sham) from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis.
Monthly sham administration through Month 11 (Year 1) NOTE: At Month 12, participants continue to receive monthly sham administration from Month 12 to Month 23 (Year 2) - Year 2 is not included in the primary analysis.