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RECRUITING Phase 2 ClinicalTrials.gov

Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD

Sponsor: ONL Therapeutics • ClinicalTrials.gov ID: NCT06659445

Registry updated: 2026-09-10
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Description

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.

Interventions

  • ONL1204 Opthalmic solution (Drug)
    Liquid formulation ONL1204 Ophthalmic Solution administered by intravitreal (IVT) injection
  • Avacincaptad Pegol intravitreal solution (Drug)
    Liquid formulation Avacincaptad Pegol administered by intravitreal (IVT) injection
  • Sham (Other)
    Sham injection

Eligibility criteria

Inclusion Criteria: 1. 55 years of age or older at Screening. 2. Able and willing to give informed consent and attend study visits. 3. Women or intersex individuals must be willing to use 2 forms of effective contraception during the study and for at least 90 days following the last dose of study drug, be postmenopausal for at least 12 months prior to study entry, or surgically sterile. If of childbearing potential, a negative urine pregnancy test is required at Screening and prior to the administration of study drug at each visit. 4. Men or intersex individuals with partners of childbearing potential must be willing to use permissible methods of contraception and refrain from sperm donation during the study and for at least 90 days following the last dose of study drug. 5. If currently using Age-related Eye Disease Study 2 (AREDS, AREDS2, or similar nutraceutical therapy at Screening, patient must be willing to continue use for the duration of the study. If not currently using AREDS2 or similar, patient must be willing to continue not to use therapy for the duration of the study. Patient must agree to choose either approach. Study Eye Inclusion Criteria: 6. BCVA of 24 letters or more using ETDRS charts in the study eye at Screening. 7. Intraocular pressure (IOP) of 22 mmHg or lower in the study eye at Screening. The GA lesion must meet all the following criteria: 8. Non-foveal GA associated with AMD without eMNV in the study eye per Investigator's evaluation and as confirmed by the central RC. 9. GA ≥0.85 disc area (DA) (2.125 mm2) and ≤8.05 DA (20.125 mm2) in the study eye as confirmed by the central RC. 10. 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. 11. Non-foveal GA (GA lesion up to the fovea, but not subfoveal) with the lesion's closest border 1725 microns or less from the foveal center in the study eye, as confirmed by the central RC. 12. The entire GA lesion in the study eye must be completely visualized on the macula-centered FAF image, must be able to be imaged in its entirety, and must not be contiguous with any areas of peripapillary atrophy per the Investigator's evaluation and as confirmed by the central RC. 13. A pattern of hyper-autofluorescence in the junctional zone of GA in the study eye must be present as confirmed by the central RC. Fellow Eye Inclusion Criterion: 14. BCVA of 19 letters or more using ETDRS charts in the fellow eye at Screening. Exclusion Criteria: 1. Current or planned participation in another investigational clinical study or use of any other investigational drugs or devices at least 6 months prior to enrollment or during the study period without prior written Sponsor approval. 2. Previous ophthalmic disease gene therapy or planned participation in any gene therapy clinical study during the study period. 3. Current or planned use of systemic complement inhibitors during the study period. 4. Any ocular or systemic condition that, in the opinion of the Investigator, makes the patient unsuitable for treatment with an investigational drug or that would compromise the safety or efficacy assessments of the study. 5. Treatment with any ocular or systemic medication that is known to be toxic to the lens, retina, or optic nerve (including, but not limited to, aminoglycosides, vancomycin, hydroxychloroquine, interferon, tacrolimus, cisplatin, bis-chloroethyl nitrosourea, carmustine, ethambutol, and tamoxifen) within 90 days prior to Screening or anticipated during the study period. 6. Any previous treatment of pentosan polysulfate (Elmiron®) is exclusionary. 7. Known allergy to fluorescein, povidone iodine, or any ingredients of the study drug or avacincaptad pegol intravitreal solution. 8. Individuals who are currently pregnant, planning to become pregnant, or are nursing at Screening or during the study period. Study Eye Exclusion Criteria: 9. Active ocular or periocular infection in the study eye. 10. Any contraindication to an IVT injection in the study eye. 11. Any media opacity in the study eye that limits visual acuity, clinical visualization of the retina, or retinal imaging as determined by the Investigator. 12. Previous IVT pharmaceutical treatment in the study eye with any agent except Food and Drug Administration (FDA)-approved complement inhibitors and treatment with FDA-approved complement inhibitors within 12 weeks prior to Screening. 13. Any history of incisional retinal surgery in the study eye including but not limited to scleral buckle or vitrectomy. (Retinal laser for a tear or hole 3 months or more prior to Screening is not exclusionary). 14. History of incisional glaucoma surgery including trabeculectomy, tube shunt, or minimally invasive glaucoma surgery in the study eye. (Glaucoma laser procedures performed at least 6 months prior to Screening are not exclusionary). 15. Yttrium aluminum garnet capsulotomy in the study eye within 1 month prior to Screening. 16. Cataract surgery in the study eye planned or expected during the study period. 17. Aphakia with absence of the posterior capsule in the study eye. (Pseudophakia with an open posterior capsule is not exclusionary). 18. Any current evidence or history in the study eye of exudative ("wet") AMD, including any RPE rips or evidence of actively leaking neovascularization anywhere in the retina based on the FA or SD-OCT as assessed per the Investigator's evaluation and confirmed by the central RC. 19. Any clinically significant retinal disease other than AMD except benign degenerative conditions (eg, Cobblestone degeneration) in the study eye. 20. Intraocular surgery in the study eye (including lens replacement surgery) within 3 months prior to Screening. See Exclusion Criteria 12 and 13 pertaining to retinal and glaucoma surgery, respectively. 21. Previous therapeutic radiation (including transpupillary thermotherapy, photodynamic therapy, or external-beam) in the region of the study eye. Fellow Eye Exclusion Criterion: 22. Planned or expected IVT injection in the fellow eye for treatment of GA with agents other than FDA-approved complement inhibitors (pegcetacoplan or avacincaptad pegol IVT solution \[Izervay™\]) during the study period. Either Eye Exclusion Criteria: 23. Active intraocular inflammation in either eye or a history of uveitis or endophthalmitis in either eye. 24. GA in either eye due to causes other than AMD. 25. Any ophthalmic condition in either eye that is likely to require surgery during the study period.

Conditions

Geographic Atrophy (GA) Age - Related Macular Degeneration (AMD)

Locations

  • Associated Retina Consultants — Gilbert, Arizona, United States
  • Associated Retina Consultants — Phoenix, Arizona, United States
  • California Retina Consultants — Bakersfield, California, United States
  • Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
  • Macula and Retina Institute — Glendale, California, United States
  • Salehi Retina Institute, dba Retina Associates of Southern California — Huntington Beach, California, United States
  • Desert Retina Consultants — Palm Desert, California, United States
  • Retinal Consultants Medical Group — Sacramento, California, United States
  • Bay Area Retina Associates — Walnut Creek, California, United States
  • Retina Consultants of Southern Colorado — Colorado Springs, Colorado, United States
  • Retina Group of New England — Waterford, Connecticut, United States
  • Florida Retina Institute — Orlando, Florida, United States
  • Retina Specialty Institute — Pensacola, Florida, United States
  • Retina Group of Florida — Sarasota, Florida, United States
  • Retina Associates of Florida, LLC — Tampa, Florida, United States
  • Northwestern Medical Group — Chicago, Illinois, United States
  • The University of Chicago Medicine Duchossois Center for Advanced Medicine — Chicago, Illinois, United States
  • Retina Associates, Ltd. — Elmhurst, Illinois, United States
  • Illinois Retina Associates, S.C. — Oak Park, Illinois, United States
  • Retina Partners Midwest, P.C. — Carmel, Indiana, United States
  • The Retina Group of Washington — Chevy Chase, Maryland, United States
  • Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
  • Retina Specialists — Towson, Maryland, United States
  • Retina Research Institute at New England Retina Consultants — Springfield, Massachusetts, United States
  • University of Michigan Kellogg Eye Center — Ann Arbor, Michigan, United States
  • Associated Retinal Consultants, P.C. — Royal Oak, Michigan, United States
  • Associated Retinal Consultants, P.C. — Traverse City, Michigan, United States
  • Mayo Clinic — Rochester, Minnesota, United States
  • The Retina Institute — St Louis, Missouri, United States
  • Sierra Eye Associates — Reno, Nevada, United States
  • Retina Vitreous Surgeons of CNY, PC — Liverpool, New York, United States
  • Ophthalmic Consultants of Long Island — Oceanside, New York, United States
  • Retina Associates of Western NY — Rochester, New York, United States
  • Long Island Vitreoretinal Consultants — Westbury, New York, United States
  • North Carolina Retina Associates — Cary, North Carolina, United States
  • Duke Eye Center — Durham, North Carolina, United States
  • North Carolina Retina Associates — Greenville, North Carolina, United States
  • North Carolina Retina Associates, S.C. — Wake Forest, North Carolina, United States
  • Cleveland Clinic Foundation-Cole Eye Institute — Cleveland, Ohio, United States
  • Erie Retina Research, LLC (Clinic) — Erie, Pennsylvania, United States
  • Charleston Neuroscience Institute — Mt. Pleasant, South Carolina, United States
  • Palmetto Retina Center — West Columbia, South Carolina, United States
  • Vanderbilt Eye Institute — Nashville, Tennessee, United States
  • Austin Retina Associates — Austin, Texas, United States
  • Retina Consultants of Texas — Beaumont, Texas, United States
  • Retina Consultants of Texas — Bellaire, Texas, United States
  • Retina Consultants of Texas — Katy, Texas, United States
  • Valley Retina Institute, P.A. — McAllen, Texas, United States
  • Medical Center Ophthalmology Associates, LLP — San Antonio, Texas, United States
  • Retina Associates of South Texas, PA — San Antonio, Texas, United States
  • Retina Consultants of Texas — San Antonio, Texas, United States
  • Retina Center of Texas — Southlake, Texas, United States
  • Retina Consultants of Texas — The Woodlands, Texas, United States
  • Piedmont Eye Center — Lynchburg, Virginia, United States
  • Pacific Northwest Retina — Bellevue, Washington, United States
  • Pacific Northwest Retina, PLLC — Silverdale, Washington, United States
  • Konventhospital der Barmherzigen Brüder Linz Abteilung für Augenheilkunde — Linz, Austria, Austria
  • Medizinische Universität Wien — Vienna, Austria, Austria
  • Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute — Vienna, Austria, Austria
  • St. Joseph's Health Care London - Ivey Eye Institute — London, Ontario, Canada
  • Toronto Retina Institute — Toronto, Ontario, Canada
  • Toronto Western Hospital, University Health Network — Toronto, Ontario, Canada
  • Clinique d'ophtalmologie des Laurentides — Boisbriand, Quebec, Canada
  • VISUS spol. s.r.o. — Náchod, Czech Republic, Czechia
  • Fakultni nemocnice Kralovske Vinohrady — Prague, Czech Republic, Czechia
  • VFN Praha — Prague, Czech Republic, Czechia
  • Axon Clinical, s.r.o. — Prague, Czech Republic, Czechia
  • NEMOS Medical Private Care s.r.o. — Sokolov, Czech Republic, Czechia
  • Augen-Zentrum-Nordwest — Ahaus, Germany, Germany
  • Universitäts-Augenklinik Bonn — Bonn, Germany, Germany
  • Internationale Innovative Ophthalmochirurgie GbR c/o MVZ Breyer Kaymak Klabe Augenchirurgie — Düsseldorf, Germany, Germany
  • Augenzentrum Prof. Dr. Koch GmbH — Frankfurt am Main, Germany, Germany
  • Philipps-Universität Marburg — Marburg, Germany, Germany
  • Uniklinikum Würzburg — Würzburg, Germany, Germany
  • General Hospital of Athens "G. Gennimatas", 1st University Eye Clinic — Athens, Greece, Greece
  • University General Hospital "Attikon", 2nd Department of Ophthalmology, University of Athens — Athens, Greece, Greece
  • University General Hospital of Heraklion — Heraklion, Greece, Greece
  • University General Hospital of Ioannina, Ophthalmology Clinica — Ioannina, Greece, Greece
  • University General Hospital of Patras, Department of Ophthalmology — Pátrai, Greece, Greece
  • Észak-Pesti Centrumkórház-Honvédkórház, Szemészeti Osztály — Budapest, Hungry, Hungary
  • Semmelweis Egyetem, Szemészeti Klinika Kutatóközpont — Budapest, Hungry, Hungary
  • Budapesti Bajcsy-Zsilinszky Kórház és Rendelőintézet, Szemészeti Osztály — Budapest, Hungry, Hungary
  • Budapest Retina Associates, Opthalmology — Budapest, Hungry, Hungary
  • Budapesti Jahn Ferenc Dél-pesti Kórház és Rendelőintézet, Szemészeti Osztály — Budapest, Hungry, Hungary
  • Debreceni Egyetem Klinikai Központ, Szemklinika — Debrecen, Hungry, Hungary
  • Pécsi Tudományegyetem Klinikai Kozpont, Szemeszeti Klinika — Pécs, Hungry, Hungary
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szemészeti Klinika — Szeged, Hungry, Hungary
  • Oculomedica Sp. z o.o. — Bydgoszcz, Poland, Poland
  • Optimum Profesorskie Centrum Okulistyki sp. z o.o. — Gdansk, Poland, Poland
  • Szpital Św. Róży sp. z o. o. sp. k. — Krakow, Poland, Poland
  • Centrum Medyczne Dietla 19 sp. z o.o. — Krakow, Poland, Poland
  • Klinika Okulistyczna Jasne Blonia sp. z o.o — Lodz, Poland, Poland
  • Bonifraterskie Centrum Medyczne sp. z o.o. — Lodz, Poland, Poland
  • Centrum Diagnostyki I Mikrochirurgii Oka Lens sp. Z o.o. — Olsztyn, Poland, Poland
  • AIBILI — Coimbra, Portugal, Portugal
  • Unidade Local de Saúde de Coimbra — Coimbra, Portugal, Portugal
  • Unidade Local de Saude de Gaia/Espinho — Gaia, Portugal, Portugal
  • Unidade Local De Saude De Santo Antonio — Porto, Portugal, Portugal
  • Centro de Oftalmología Barraquer — Barcelona, Spain, Spain
  • Institut Catalâ de Retina — Barcelona, Spain, Spain
  • Instituto Clinico Quirurgico de Oftalmologia (ICQO) — Bilbao, Spain, Spain
  • Hospital Arruzafa — Córdoba, Spain, Spain
  • Hospital Universitario Puerta de Hierro Majadahonda — Madrid, Spain, Spain
  • Hospital Universitario Virgen Macarena — Seville, Spain, Spain
  • Fundación de Oftalmologia Medica de la Comunitat Valenciana (FOM) — Valencia, Spain, Spain
  • Hospital Universitario Miguel Servet — Zaragoza, Spain, Spain
  • Augenarzt Praxisgemeinschaft Gutblick AG — Bern, Switzerland, Switzerland
  • Vista Augenklinik Binningen — Binningen, Switzerland, Switzerland
  • Hospital Ophthalmic Jules-Gonin Foundation — Lausanne, Switzerland, Switzerland
  • Swiss Visio Retina Research Center — Lausanne, Switzerland, Switzerland
  • Stadtspital Zurich Triemli, Augenklinik, Forschungszentrum, 2K.14 — Zurich, Switzerland, Switzerland
  • Augenarzt Praxisgemeinschaft Gutblick AG — Zurich, Switzerland, Switzerland
  • Gloucestershire Hospitals NHS Foundation Trust — Gloucester, England, United Kingdom
  • King's College Hospital NHS Foundation Trust — London, England, United Kingdom
  • The Retina Clinic — London, England, United Kingdom
  • Newcastle Upon Tyne NHS Foundation Trust — Newcastle, England, United Kingdom
  • University Hospital Southampton NHS Foundation Trust — Southampton, England, United Kingdom
  • Sunderland Eye Infirmary — Sunderland, England, United Kingdom
  • Hull University Teaching Hospitals NHS Trust, Hull Royal Infirmary — York, England, United Kingdom
  • Royal Victoria Hospital (Ophthalmology Research Suite, EODU) — Belfast, Ireland, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record