Phase
Condition
Macular Degeneration
Geographic Atrophy
Treatment
Sham
ONL1204 Opthalmic solution
Avacincaptad Pegol intravitreal solution
Clinical Study ID
Ages > 55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
55 years of age or older at Screening.
Able and willing to give informed consent and attend study visits.
Women or intersex individuals must be willing to use 2 forms of effectivecontraception during the study and for at least 90 days following the last dose ofstudy drug, be postmenopausal for at least 12 months prior to study entry, orsurgically sterile. If of childbearing potential, a negative urine pregnancy test isrequired at Screening and prior to the administration of study drug at each visit.
Men or intersex individuals with partners of childbearing potential must be willingto use permissible methods of contraception and refrain from sperm donation duringthe study and for at least 90 days following the last dose of study drug.
If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similarnutraceutical therapy at Screening, patient must be willing to continue use for theduration of the study. If not currently using AREDS2 or similar, patient must bewilling to continue not to use therapy for the duration of the study. Patient mustagree to choose either approach. Study Eye Inclusion Criteria:
BCVA of 24 letters or more using ETDRS charts in the study eye at Screening.
Intraocular pressure (IOP) of 22 mmHg or lower in the study eye at Screening. The GA lesion must meet all the following criteria:
Non-foveal GA associated with AMD without eMNV in the study eye per Investigator'sevaluation and as confirmed by the central RC.
GA ≥0.85 disc area (DA) (2.125 mm2) and ≤8.05 DA (20.125 mm2) in the study eye asconfirmed by the central RC.
If GA in the study eye is multifocal, at least 1 focal lesion must be ≥0.425 DA (1.063 mm2) as confirmed by the central RC.
Non-foveal GA (GA lesion up to the fovea, but not subfoveal) with the lesion'sclosest border 1725 microns or less from the foveal center in the study eye, asconfirmed by the central RC.
The entire GA lesion in the study eye must be completely visualized on themacula-centered FAF image, must be able to be imaged in its entirety, and must notbe contiguous with any areas of peripapillary atrophy per the Investigator'sevaluation and as confirmed by the central RC.
A pattern of hyper-autofluorescence in the junctional zone of GA in the study eyemust be present as confirmed by the central RC. Fellow Eye Inclusion Criterion:
BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening.
Exclusion
Exclusion Criteria:
Current or planned participation in another investigational clinical study or use ofany other investigational drugs or devices at least 6 months prior to enrollment orduring the study period without prior written Sponsor approval.
Previous ophthalmic disease gene therapy or planned participation in any genetherapy clinical study during the study period.
Current or planned use of systemic complement inhibitors during the study period.
Any ocular or systemic condition that, in the opinion of the Investigator, makes thepatient unsuitable for treatment with an investigational drug or that wouldcompromise the safety or efficacy assessments of the study.
Treatment with any ocular or systemic medication that is known to be toxic to thelens, retina, or optic nerve (including, but not limited to, aminoglycosides,vancomycin, hydroxychloroquine, interferon, tacrolimus, cisplatin, bis-chloroethylnitrosourea, carmustine, ethambutol, and tamoxifen) within 90 days prior toScreening or anticipated during the study period.
Any previous treatment of pentosan polysulfate (Elmiron®) is exclusionary.
Known allergy to fluorescein, povidone iodine, or any ingredients of the study drugor avacincaptad pegol intravitreal solution.
Individuals who are currently pregnant, planning to become pregnant, or are nursingat Screening or during the study period. Study Eye Exclusion Criteria:
Active ocular or periocular infection in the study eye.
Any contraindication to an IVT injection in the study eye.
Any media opacity in the study eye that limits visual acuity, clinical visualizationof the retina, or retinal imaging as determined by the Investigator.
Previous IVT pharmaceutical treatment in the study eye with any agent except Foodand Drug Administration (FDA)-approved complement inhibitors and treatment withFDA-approved complement inhibitors within 12 weeks prior to Screening.
Any history of incisional retinal surgery in the study eye including but not limitedto scleral buckle or vitrectomy. (Retinal laser for a tear or hole 3 months or moreprior to Screening is not exclusionary).
History of incisional glaucoma surgery including trabeculectomy, tube shunt, orminimally invasive glaucoma surgery in the study eye. (Glaucoma laser proceduresperformed at least 6 months prior to Screening are not exclusionary).
Yttrium aluminum garnet capsulotomy in the study eye within 1 month prior toScreening.
Cataract surgery in the study eye planned or expected during the study period.
Aphakia with absence of the posterior capsule in the study eye. (Pseudophakia withan open posterior capsule is not exclusionary).
Any current evidence or history in the study eye of exudative ("wet") AMD, includingany RPE rips or evidence of actively leaking neovascularization anywhere in theretina based on the FA or SD-OCT as assessed per the Investigator's evaluation andconfirmed by the central RC.
Any clinically significant retinal disease other than AMD except benign degenerativeconditions (eg, Cobblestone degeneration) in the study eye.
Intraocular surgery in the study eye (including lens replacement surgery) within 3months prior to Screening. See Exclusion Criteria 12 and 13 pertaining to retinaland glaucoma surgery, respectively.
Previous therapeutic radiation (including transpupillary thermotherapy, photodynamictherapy, or external-beam) in the region of the study eye. Fellow Eye Exclusion Criterion:
Planned or expected IVT injection in the fellow eye for treatment of GA with agentsother than FDA-approved complement inhibitors (pegcetacoplan or avacincaptad pegolIVT solution [Izervay™]) during the study period. Either Eye Exclusion Criteria:
Active intraocular inflammation in either eye or a history of uveitis orendophthalmitis in either eye.
GA in either eye due to causes other than AMD.
Any ophthalmic condition in either eye that is likely to require surgery during thestudy period.
Study Design
Connect with a study center
Konventhospital der Barmherzigen Brüder Linz Abteilung für Augenheilkunde
Linz, Austria 4020
AustriaActive - Recruiting
Medizinische Universität Wien
Vienna, Austria 1090
AustriaActive - Recruiting
Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute
Vienna, Austria 1140
AustriaActive - Recruiting
St. Joseph's Health Care London - Ivey Eye Institute
London, Ontario N6A4V2
CanadaActive - Recruiting
Toronto Retina Institute
Toronto, Ontario M3C0G9
CanadaActive - Recruiting
Toronto Western Hospital, University Health Network
Toronto, Ontario M5T 2S8
CanadaActive - Recruiting
Clinique d'ophtalmologie des Laurentides
Boisbriand, Quebec J7H0E8
CanadaActive - Recruiting
VISUS spol. s.r.o.
Náchod, Czech Republic 574 01
CzechiaActive - Recruiting
Axon Clinical, s.r.o.
Prague, Czech Republic 150 00
CzechiaActive - Recruiting
Fakultni nemocnice Kralovske Vinohrady
Prague, Czech Republic 100 34
CzechiaActive - Recruiting
VFN Praha
Prague, Czech Republic 128 08
CzechiaActive - Recruiting
NEMOS Medical Private Care s.r.o.
Sokolov, Czech Republic 356 01
CzechiaActive - Recruiting
Augen-Zentrum-Nordwest
Ahaus, Germany 48683
GermanyActive - Recruiting
Universitäts-Augenklinik Bonn
Bonn, Germany 53127
GermanyActive - Recruiting
Internationale Innovative Ophthalmochirurgie GbR c/o MVZ Breyer Kaymak Klabe Augenchirurgie
Düsseldorf, Germany 40549
GermanyActive - Recruiting
Augenzentrum Prof. Dr. Koch GmbH
Frankfurt am Main, Germany 60549
GermanyActive - Recruiting
Philipps-Universität Marburg
Marburg, Germany 35043
GermanyActive - Recruiting
Uniklinikum Würzburg
Würzburg, Germany 97080
GermanyActive - Recruiting
General Hospital of Athens "G. Gennimatas", 1st University Eye Clinic
Athens, Greece 11527
GreeceActive - Recruiting
University General Hospital "Attikon", 2nd Department of Ophthalmology, University of Athens
Athens, Greece 12462
GreeceActive - Recruiting
University General Hospital of Heraklion
Heraklion, Greece 70013
GreeceActive - Recruiting
University General Hospital of Ioannina, Ophthalmology Clinica
Ioannina, Greece 45500
GreeceActive - Recruiting
University General Hospital of Patras, Department of Ophthalmology
Pátrai, Greece 26504
GreeceActive - Recruiting
Budapest Retina Associates, Opthalmology
Budapest, Hungry 1133
HungaryActive - Recruiting
Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet, Szemészeti Osztály
Budapest, Hungry 1106
HungaryActive - Recruiting
Budapesti Jahn Ferenc Dél-pesti Kórház és Rendelőintézet, Szemészeti Osztály
Budapest, Hungry 1204
HungaryActive - Recruiting
Semmelweis Egyetem, Szemészeti Klinika Kutatóközpont
Budapest, Hungry 1085
HungaryActive - Recruiting
Észak-Pesti Centrumkórház-Honvédkórház, Szemészeti Osztály
Budapest, Hungry 1062
HungaryActive - Recruiting
Debreceni Egyetem Klinikai Központ, Szemklinika
Debrecen, Hungry 4032
HungaryActive - Recruiting
Pécsi Tudományegyetem Klinikai Kozpont, Szemeszeti Klinika
Pécs, Hungry 7623
HungaryActive - Recruiting
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szemészeti Klinika
Szeged, Hungry 6720
HungaryActive - Recruiting
Oculomedica Sp. z o.o.
Bydgoszcz, Poland 85-157
PolandActive - Recruiting
Optimum Profesorskie Centrum Okulistyki sp. z o.o.
Gdansk, Poland 80-180
PolandActive - Recruiting
Centrum Medyczne Dietla 19 sp. z o.o.
Krakow, Poland 31-070
PolandActive - Recruiting
Szpital Św. Róży sp. z o. o. sp. k.
Krakow, Poland 30-394
PolandActive - Recruiting
Bonifraterskie Centrum Medyczne sp. z o.o.
Lodz, Poland 93-357
PolandActive - Recruiting
Klinika Okulistyczna Jasne Blonia sp. z o.o
Lodz, Poland 91-134
PolandActive - Recruiting
Centrum Diagnostyki I Mikrochirurgii Oka Lens sp. Z o.o.
Olsztyn, Poland 10-424
PolandActive - Recruiting
AIBILI
Coimbra, Portugal 3000-548
PortugalActive - Recruiting
Unidade Local de Saúde de Coimbra
Coimbra, Portugal 3004-561
PortugalActive - Recruiting
Unidade Local de Saude de Gaia/Espinho
Gaia, Portugal 4434-502
PortugalActive - Recruiting
Unidade Local De Saude De Santo Antonio
Porto, Portugal 4050-011
PortugalActive - Recruiting
Centro de Oftalmología Barraquer
Barcelona, Spain 08021
SpainActive - Recruiting
Institut Catalâ de Retina
Barcelona, Spain 08022
SpainActive - Recruiting
Instituto Clinico Quirurgico de Oftalmologia (ICQO)
Bilbao, Spain 48010
SpainActive - Recruiting
Hospital Arruzafa
Córdoba, Spain 14012
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, Spain 28222
SpainActive - Recruiting
Hospital Universitario Virgen Macarena
Seville, Spain 41009
SpainActive - Recruiting
Fundación de Oftalmologia Medica de la Comunitat Valenciana (FOM)
Valencia, Spain 46015
SpainActive - Recruiting
Hospital Universitario Miguel Servet
Zaragoza, Spain 50009
SpainActive - Recruiting
Augenarzt Praxisgemeinschaft Gutblick AG
Bern, Switzerland 3011
SwitzerlandActive - Recruiting
Vista Augenklinik Binningen
Binningen, Switzerland 4102
SwitzerlandActive - Recruiting
Hospital Ophthalmic Jules-Gonin Foundation
Lausanne, Switzerland 1001
SwitzerlandActive - Recruiting
Swiss Visio Retina Research Center
Lausanne, Switzerland 1006
SwitzerlandActive - Recruiting
Augenarzt Praxisgemeinschaft Gutblick AG
Zurich, Switzerland 8620
SwitzerlandActive - Recruiting
Stadtspital Zurich Triemli, Augenklinik, Forschungszentrum, 2K.14
Zurich, Switzerland 8063
SwitzerlandActive - Recruiting
Gloucestershire Hospitals NHS Foundation Trust
Gloucester, England GL1 3NN
United KingdomActive - Recruiting
King's College Hospital NHS Foundation Trust
London, England SE5 9RS
United KingdomActive - Recruiting
The Retina Clinic
London, England W1G 9X
United KingdomActive - Recruiting
Newcastle Upon Tyne NHS Foundation Trust
Newcastle, England NE1 4LP
United KingdomActive - Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, England SO16 6YD
United KingdomActive - Recruiting
Sunderland Eye Infirmary
Sunderland, England SR2 9HP
United KingdomActive - Recruiting
Hull University Teaching Hospitals NHS Trust, Hull Royal Infirmary
York, England HU3 2JZ
United KingdomActive - Recruiting
Royal Victoria Hospital (Ophthalmology Research Suite, EODU)
Belfast, Ireland BT12 6BA
United KingdomActive - Recruiting
Associated Retina Consultants
Gilbert, Arizona 85297
United StatesActive - Recruiting
Associated Retina Consultants
Phoenix, Arizona 85020
United StatesActive - Recruiting
California Retina Consultants
Bakersfield, California 93309
United StatesActive - Recruiting
Retina-Vitreous Associates Medical Group
Beverly Hills, California 90211
United StatesActive - Recruiting
Macula and Retina Institute
Glendale, California 91203
United StatesActive - Recruiting
Salehi Retina Institute, dba Retina Associates of Southern California
Huntington Beach, California 92647
United StatesActive - Recruiting
Desert Retina Consultants
Palm Desert, California 92211
United StatesActive - Recruiting
Retinal Consultants Medical Group
Sacramento, California 95841
United StatesActive - Recruiting
Bay Area Retina Associates
Walnut Creek, California 94598
United StatesActive - Recruiting
Retina Consultants of Southern Colorado
Colorado Springs, Colorado 80909-1183
United StatesActive - Recruiting
Retina Group of New England
Waterford, Connecticut 06385
United StatesActive - Recruiting
Florida Retina Institute
Orlando, Florida 32806
United StatesActive - Recruiting
Retina Specialty Institute
Pensacola, Florida 32503
United StatesActive - Recruiting
Retina Group of Florida
Sarasota, Florida 34232
United StatesActive - Recruiting
Retina Associates of Florida, LLC
Tampa, Florida 33609-4614
United StatesActive - Recruiting
Northwestern Medical Group
Chicago, Illinois 60611
United StatesActive - Recruiting
The University of Chicago Medicine Duchossois Center for Advanced Medicine
Chicago, Illinois 60637
United StatesActive - Recruiting
Retina Associates, Ltd.
Elmhurst, Illinois 60126
United StatesActive - Recruiting
Illinois Retina Associates, S.C.
Oak Park, Illinois 60304
United StatesActive - Recruiting
Retina Partners Midwest, P.C.
Carmel, Indiana 46032
United StatesActive - Recruiting
Retina Specialists
Towson, Maryland 21204
United StatesActive - Recruiting
Retina Research Institute at New England Retina Consultants
Springfield, Massachusetts 01107
United StatesActive - Recruiting
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan 48105
United StatesActive - Recruiting
Associated Retinal Consultants, P.C.
Royal Oak, Michigan 48073
United StatesActive - Recruiting
Associated Retinal Consultants, P.C.
Traverse City, Michigan 49686
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
The Retina Institute
St Louis, Missouri 63128
United StatesActive - Recruiting
Sierra Eye Associates
Reno, Nevada 89502
United StatesActive - Recruiting
Retina Vitreous Surgeons of CNY, PC
Liverpool, New York 13088
United StatesActive - Recruiting
Ophthalmic Consultants of Long Island
Oceanside, New York 11572
United StatesActive - Recruiting
Retina Associates of Western NY
Rochester, New York 14620
United StatesActive - Recruiting
Long Island Vitreoretinal Consultants
Westbury, New York 11590
United StatesActive - Recruiting
North Carolina Retina Associates
Cary, North Carolina 27511
United StatesActive - Recruiting
Duke Eye Center
Durham, North Carolina 27710
United StatesActive - Recruiting
North Carolina Retina Associates
Greenville, North Carolina 27834
United StatesActive - Recruiting
North Carolina Retina Associates, S.C.
Wake Forest, North Carolina 27587
United StatesActive - Recruiting
Cleveland Clinic Foundation-Cole Eye Institute
Cleveland, Ohio 44195
United StatesActive - Recruiting
Erie Retina Research, LLC (Clinic)
Erie, Pennsylvania 16505
United StatesActive - Recruiting
Erie Retina Research, LLC
Erie 5188843, Pennsylvania 6254927 16507
United StatesActive - Recruiting
Charleston Neuroscience Institute
Mt. Pleasant, South Carolina 29464
United StatesActive - Recruiting
Palmetto Retina Center
West Columbia, South Carolina 29169
United StatesActive - Recruiting
Vanderbilt Eye Institute
Nashville, Tennessee 37232
United StatesActive - Recruiting
Austin Retina Associates
Austin, Texas 78705
United StatesActive - Recruiting
Retina Consultants of Texas
Beaumont, Texas 77707
United StatesActive - Recruiting
Retina Consultants of Texas
Bellaire, Texas 77401
United StatesActive - Recruiting
Retina Consultants of Texas
Katy, Texas 77494
United StatesActive - Recruiting
Valley Retina Institute, P.A.
McAllen, Texas 78503
United StatesActive - Recruiting
Retina Associates of South Texas, PA
San Antonio, Texas 78240
United StatesActive - Recruiting
Retina Consultants of Texas
San Antonio, Texas 78240
United StatesActive - Recruiting
Retina Center of Texas
Southlake, Texas 76092
United StatesActive - Recruiting
Retina Consultants of Texas
The Woodlands, Texas 77384
United StatesActive - Recruiting
Retina Consultants of Texas
San Antonio 4726206, Texas 4736286 78240
United StatesActive - Recruiting
Piedmont Eye Center
Lynchburg, Virginia 24502
United StatesActive - Recruiting
Pacific Northwest Retina
Bellevue, Washington 98004
United StatesActive - Recruiting
Pacific Northwest Retina, PLLC
Silverdale, Washington 98383
United StatesActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.