Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
Start Date
10/28/2025
Completion Date
11/1/2028
Summary
The purpose of this study is to collect efficacy and safety information of intravitreal injection for 3 experimental arms, including 2 dose levels of ONL1204 and 2 treatment frequencies in patients with GA associated with AMD. GA associated with AMD is one of the world's leading causes of visual disability and legal blindness globally. Associated with aging, cigarette smoking, obesity, diets low in certain nutrients, a lifestyle related to cardiac risk, and a growing list of genetic factors, AMD is becoming an increasingly prevalent public health concern, especially as the global population ages. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease, including models of dry AMD.
Eligibility Criteria
Age Range: 55 years to No maximum
Interventions
ONL1204 Opthalmic solution
Avacincaptad Pegol intravitreal solution
Sham
Conditions
Locations
Associated Retina Consultants
Gilbert, Arizona 85297
United States
Associated Retina Consultants
Phoenix, Arizona 85020
United States
California Retina Consultants
Bakersfield, California 93309
United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United States
Macula and Retina Institute
Glendale, California 91203
United States
Salehi Retina Institute, dba Retina Associates of Southern California
Huntington Beach, California 92647
United States
Desert Retina Consultants
Palm Desert, California 92211
United States
Retinal Consultants Medical Group
Sacramento, California 95841
United States
Bay Area Retina Associates
Walnut Creek, California 94598
United States
Retina Consultants of Southern Colorado
Colorado Springs, Colorado 80909-1183
United States
Retina Group of New England
Waterford, Connecticut 06385
United States
Florida Retina Institute
Orlando, Florida 32806
United States
Retina Specialty Institute
Pensacola, Florida 32503
United States
Retina Group of Florida
Sarasota, Florida 34232
United States
Retina Associates of Florida, LLC
Tampa, Florida 33609-4614
United States
Northwestern Medical Group
Chicago, Illinois 60611
United States
The University of Chicago Medicine Duchossois Center for Advanced Medicine
Chicago, Illinois 60637
United States
Retina Associates, Ltd.
Elmhurst, Illinois 60126
United States
Illinois Retina Associates, S.C.
Oak Park, Illinois 60304
United States
Retina Partners Midwest, P.C.
Carmel, Indiana 46032
United States
The Retina Group of Washington
Chevy Chase, Maryland 20815
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland 21740
United States
Retina Specialists
Towson, Maryland 21204
United States
Retina Research Institute at New England Retina Consultants
Springfield, Massachusetts 01107
United States
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan 48105
United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan 48073
United States
Associated Retinal Consultants, P.C.
Traverse City, Michigan 49686
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
The Retina Institute
St Louis, Missouri 63128
United States
Sierra Eye Associates
Reno, Nevada 89502
United States
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York 13088
United States
Ophthalmic Consultants of Long Island
Oceanside, New York 11572
United States
Retina Associates of Western NY
Rochester, New York 14620
United States
Long Island Vitreoretinal Consultants
Westbury, New York 11590
United States
North Carolina Retina Associates
Cary, North Carolina 27511
United States
Duke Eye Center
Durham, North Carolina 27710
United States
North Carolina Retina Associates
Greenville, North Carolina 27834
United States
North Carolina Retina Associates, S.C.
Wake Forest, North Carolina 27587
United States
Cleveland Clinic Foundation-Cole Eye Institute
Cleveland, Ohio 44195
United States
Erie Retina Research, LLC (Clinic)
Erie, Pennsylvania 16505
United States
Charleston Neuroscience Institute
Mt. Pleasant, South Carolina 29464
United States
Palmetto Retina Center
West Columbia, South Carolina 29169
United States
Vanderbilt Eye Institute
Nashville, Tennessee 37232
United States
Austin Retina Associates
Austin, Texas 78705
United States
Retina Consultants of Texas
Beaumont, Texas 77707
United States
Retina Consultants of Texas
Bellaire, Texas 77401
United States
Retina Consultants of Texas
Katy, Texas 77494
United States
Valley Retina Institute, P.A.
McAllen, Texas 78503
United States
Medical Center Ophthalmology Associates, LLP
San Antonio, Texas 78240
United States
Retina Associates of South Texas, PA
San Antonio, Texas 78240
United States
Retina Consultants of Texas
San Antonio, Texas 78240
United States
Retina Center of Texas
Southlake, Texas 76092
United States
Retina Consultants of Texas
The Woodlands, Texas 77384
United States
Piedmont Eye Center
Lynchburg, Virginia 24502
United States
Pacific Northwest Retina
Bellevue, Washington 98004
United States
Pacific Northwest Retina, PLLC
Silverdale, Washington 98383
United States
Konventhospital der Barmherzigen Brüder Linz Abteilung für Augenheilkunde
Linz, Austria 4020
Austria
Medizinische Universität Wien
Vienna, Austria 1090
Austria
Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute
Vienna, Austria 1140
Austria
St. Joseph's Health Care London - Ivey Eye Institute
London, Ontario N6A4V2
Canada
Toronto Retina Institute
Toronto, Ontario M3C0G9
Canada
Toronto Western Hospital, University Health Network
Toronto, Ontario M5T 2S8
Canada
Clinique d'ophtalmologie des Laurentides
Boisbriand, Quebec J7H0E8
Canada
VISUS spol. s.r.o.
Náchod, Czech Republic 574 01
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czech Republic 100 34
Czechia
VFN Praha
Prague, Czech Republic 128 08
Czechia
Axon Clinical, s.r.o.
Prague, Czech Republic 150 00
Czechia
NEMOS Medical Private Care s.r.o.
Sokolov, Czech Republic 356 01
Czechia
Augen-Zentrum-Nordwest
Ahaus, Germany 48683
Germany
Universitäts-Augenklinik Bonn
Bonn, Germany 53127
Germany
Internationale Innovative Ophthalmochirurgie GbR c/o MVZ Breyer Kaymak Klabe Augenchirurgie
Düsseldorf, Germany 40549
Germany
Augenzentrum Prof. Dr. Koch GmbH
Frankfurt am Main, Germany 60549
Germany
Philipps-Universität Marburg
Marburg, Germany 35043
Germany
Uniklinikum Würzburg
Würzburg, Germany 97080
Germany
General Hospital of Athens "G. Gennimatas", 1st University Eye Clinic
Athens, Greece 11527
Greece
University General Hospital "Attikon", 2nd Department of Ophthalmology, University of Athens
Athens, Greece 12462
Greece
University General Hospital of Heraklion
Heraklion, Greece 70013
Greece
University General Hospital of Ioannina, Ophthalmology Clinica
Ioannina, Greece 45500
Greece
University General Hospital of Patras, Department of Ophthalmology
Pátrai, Greece 26504
Greece
Észak-Pesti Centrumkórház-Honvédkórház, Szemészeti Osztály
Budapest, Hungry 1062
Hungary
Semmelweis Egyetem, Szemészeti Klinika Kutatóközpont
Budapest, Hungry 1085
Hungary
Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet, Szemészeti Osztály
Budapest, Hungry 1106
Hungary
Budapest Retina Associates, Opthalmology
Budapest, Hungry 1133
Hungary
Budapesti Jahn Ferenc Dél-pesti Kórház és Rendelőintézet, Szemészeti Osztály
Budapest, Hungry 1204
Hungary
Debreceni Egyetem Klinikai Központ, Szemklinika
Debrecen, Hungry 4032
Hungary
Pécsi Tudományegyetem Klinikai Kozpont, Szemeszeti Klinika
Pécs, Hungry 7623
Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szemészeti Klinika
Szeged, Hungry 6720
Hungary
Oculomedica Sp. z o.o.
Bydgoszcz, Poland 85-157
Poland
Optimum Profesorskie Centrum Okulistyki sp. z o.o.
Gdansk, Poland 80-180
Poland
Szpital Św. Róży sp. z o. o. sp. k.
Krakow, Poland 30-394
Poland
Centrum Medyczne Dietla 19 sp. z o.o.
Krakow, Poland 31-070
Poland
Klinika Okulistyczna Jasne Blonia sp. z o.o
Lodz, Poland 91-134
Poland
Bonifraterskie Centrum Medyczne sp. z o.o.
Lodz, Poland 93-357
Poland
Centrum Diagnostyki I Mikrochirurgii Oka Lens sp. Z o.o.
Olsztyn, Poland 10-424
Poland
AIBILI
Coimbra, Portugal 3000-548
Portugal
Unidade Local de Saúde de Coimbra
Coimbra, Portugal 3004-561
Portugal
Unidade Local de Saude de Gaia/Espinho
Gaia, Portugal 4434-502
Portugal
Unidade Local De Saude De Santo Antonio
Porto, Portugal 4050-011
Portugal
Centro de Oftalmología Barraquer
Barcelona, Spain 08021
Spain
Institut Catalâ de Retina
Barcelona, Spain 08022
Spain
Instituto Clinico Quirurgico de Oftalmologia (ICQO)
Bilbao, Spain 48010
Spain
Hospital Arruzafa
Córdoba, Spain 14012
Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain 28222
Spain
Hospital Universitario Virgen Macarena
Seville, Spain 41009
Spain
Fundación de Oftalmologia Medica de la Comunitat Valenciana (FOM)
Valencia, Spain 46015
Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain 50009
Spain
Augenarzt Praxisgemeinschaft Gutblick AG
Bern, Switzerland 3011
Switzerland
Vista Augenklinik Binningen
Binningen, Switzerland 4102
Switzerland
Hospital Ophthalmic Jules-Gonin Foundation
Lausanne, Switzerland 1001
Switzerland
Swiss Visio Retina Research Center
Lausanne, Switzerland 1006
Switzerland
Stadtspital Zurich Triemli, Augenklinik, Forschungszentrum, 2K.14
Zurich, Switzerland 8063
Switzerland
Augenarzt Praxisgemeinschaft Gutblick AG
Zurich, Switzerland 8620
Switzerland
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, England GL1 3NN
United Kingdom
King's College Hospital NHS Foundation Trust
London, England SE5 9RS
United Kingdom
The Retina Clinic
London, England W1G 9X
United Kingdom
Newcastle Upon Tyne NHS Foundation Trust
Newcastle, England NE1 4LP
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, England SO16 6YD
United Kingdom
Sunderland Eye Infirmary
Sunderland, England SR2 9HP
United Kingdom
Hull University Teaching Hospitals NHS Trust, Hull Royal Infirmary
York, England HU3 2JZ
United Kingdom
Royal Victoria Hospital (Ophthalmology Research Suite, EODU)
Belfast, Ireland BT12 6BA
United Kingdom