A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration
16 de septiembre de 2026 actualizado por: Amgen
A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered Via Intravitreal Injection in Participants With Neovascular Age-related Macular Degeneration
The aim of this trial is to demonstrate similarity in efficacy between ABP 938 8 mg and aflibercept (US) 8 mg by evaluating the change in best corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (nAMD)
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
304
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Amgen Call Center
- Número de teléfono: 866-572-6436
- Correo electrónico: medinfo@amgen.com
Ubicaciones de estudio
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Hradec Králové Region
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Náchod, Hradec Králové Region, Chequia, 547 01
- Reclutamiento
- Visus, spol. s r.o. - Nachod
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Prague
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Prague, Prague, Chequia, 150 00
- Reclutamiento
- AXON clinical
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Stredoceský Kraj
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Mladá Boleslav, Stredoceský Kraj, Chequia, 293 01
- Reclutamiento
- Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje - Klaudianova nemocnice
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Košice Region
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Trebišov, Košice Region, Eslovaquia, 075 01
- Reclutamiento
- NsP Trebisov, a.s. - Ocne oddelenie
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Trenčín Region
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Trenčín, Trenčín Region, Eslovaquia, 911 71
- Reclutamiento
- Fakultna nemocnica Trencin - Ocna klinika
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Žilina Region
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Žilina, Žilina Region, Eslovaquia, 012 07
- Reclutamiento
- Fakultna nemocnica s poliklinikou Zilina - Ocne oddelenie
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California
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Fullerton, California, Estados Unidos, 92835-3432
- Reclutamiento
- Retina Consultants of Orange County
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Long Beach, California, Estados Unidos, 90607
- Reclutamiento
- South Coast Retina Center - RCA
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Modesto, California, Estados Unidos, 95356
- Reclutamiento
- Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA)
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Pasadena, California, Estados Unidos, 91107
- Reclutamiento
- California Eye Specialists Medical Group, Inc
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Sacramento, California, Estados Unidos, 95825
- Reclutamiento
- Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
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Santa Barbara, California, Estados Unidos, 93103
- Reclutamiento
- California Retina Consultants
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80909-1183
- Reclutamiento
- Retina Consultants of Southern Colorado (Colorado Springs)- RCA
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Colorado Springs, Colorado, Estados Unidos, 80909
- Reclutamiento
- Retina Consultants of Southern Colorado (Pueblo)- RCA
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Lakewood, Colorado, Estados Unidos, 80228
- Reclutamiento
- Colorado Retina Associates (RCA)
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Connecticut
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Waterford, Connecticut, Estados Unidos, 06385
- Reclutamiento
- Retina Group of New England
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Florida
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Miami, Florida, Estados Unidos, 33143
- Reclutamiento
- Medeye Associates - Research
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Naples, Florida, Estados Unidos, 34103-4457
- Reclutamiento
- Retina Consultants of Southwest Florida - Naples
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Pensacola, Florida, Estados Unidos, 32503
- Reclutamiento
- Advanced Research, LLC
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Illinois
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Elmhurst, Illinois, Estados Unidos, 60126
- Reclutamiento
- Retina Associates
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Oak Forest, Illinois, Estados Unidos, 60452
- Reclutamiento
- University Retina - Bedford Park Location
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Indiana
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Carmel, Indiana, Estados Unidos, 46032
- Reclutamiento
- Associated Vitreoretinal and Uveitis Consultants
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Maryland
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Baltimore, Maryland, Estados Unidos, 21209
- Reclutamiento
- The Retina Care Center- Baltimore (PRISM Vision Group)
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Hagerstown, Maryland, Estados Unidos, 21740-5846
- Reclutamiento
- Mid Atlantic Retina Specialists
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Towson, Maryland, Estados Unidos, 21204
- Reclutamiento
- Retina Specialists
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Reclutamiento
- Ophthalmic Consultants of Boston
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Minnesota
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Edina, Minnesota, Estados Unidos, 55435
- Reclutamiento
- Retina Consultants of Minnesota
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Mississippi
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Madison, Mississippi, Estados Unidos, 39110
- Reclutamiento
- Mississippi Retina Assoc
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Missouri
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St Louis, Missouri, Estados Unidos, 63128
- Reclutamiento
- The Retina Institute, Research Retina Institute (RCA)
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New Jersey
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Bloomfield, New Jersey, Estados Unidos, 07003
- Reclutamiento
- Envision Ocular, LLC
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87109
- Reclutamiento
- Vision Research Center Eye Associates of New Mexico
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New York
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Liverpool, New York, Estados Unidos, 13088
- Reclutamiento
- Retina Vitreous Surgeons of CNY, PC
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Oceanside, New York, Estados Unidos, 11572
- Reclutamiento
- Ophthalmic Consultants of Long Island - Research
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27607-7514
- Reclutamiento
- North Carolina Retina Associates
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Wake Forest, North Carolina, Estados Unidos, 27587
- Reclutamiento
- NC Retina Associates-RCA
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Ohio
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Dublin, Ohio, Estados Unidos, 43016
- Reclutamiento
- Midwest Retina - Main Office
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Pennsylvania
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Kingston, Pennsylvania, Estados Unidos, 18704-4801
- Reclutamiento
- Eye Care Specialists - Kingston
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South Carolina
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Beaufort, South Carolina, Estados Unidos, 29902
- Reclutamiento
- Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA)
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Charleston, South Carolina, Estados Unidos, 29414-5896
- Reclutamiento
- Charleston Neuroscience Institute
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Columbia, South Carolina, Estados Unidos, 29169
- Reclutamiento
- Palmetto Retina Center - Main (RCA)
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Ladson, South Carolina, Estados Unidos, 29456
- Reclutamiento
- Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)
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Mt. Pleasant, South Carolina, Estados Unidos, 29464
- Reclutamiento
- Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA)
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West Columbia, South Carolina, Estados Unidos, 29169
- Reclutamiento
- Palmetto Retina Center, Florence (RCA)
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Tennessee Retina PC
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Texas
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Arlington, Texas, Estados Unidos, 76012
- Reclutamiento
- Texas Retina Associates (TRA) - Arlington
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Austin, Texas, Estados Unidos, 78705
- Reclutamiento
- Austin Retina Associates
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Austin, Texas, Estados Unidos, 78705
- Reclutamiento
- Austin Retina Associates - Ophthalmology/Retina
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Bellaire, Texas, Estados Unidos, 77401
- Reclutamiento
- Retina Consultants of Texas - Bellaire
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Dallas, Texas, Estados Unidos, 75231
- Reclutamiento
- Texas Retina Associates (TRA) - Dallas Main
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Fort Worth, Texas, Estados Unidos, 76104
- Reclutamiento
- Texas Retina Associates - Fort Worth
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Houston, Texas, Estados Unidos, 77401
- Reclutamiento
- Retina Consultants of Texas - Katy Retina Center
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Katy, Texas, Estados Unidos, 77494
- Reclutamiento
- Retina Consultants of Texas - The Woodlands
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San Antonio, Texas, Estados Unidos, 78240
- Reclutamiento
- Retinal Consultants of Texas- San Antonio
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Schertz, Texas, Estados Unidos, 78154
- Reclutamiento
- Retina Consultants of Texas - Schertz
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Willow Park, Texas, Estados Unidos, 76087
- Reclutamiento
- Strategic Clinical Research Group, LLC
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Utah
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Salt Lake City, Utah, Estados Unidos, 84107
- Reclutamiento
- Retina Associates of Utah - Retina Specialist
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Virginia
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Falls Church, Virginia, Estados Unidos, 22042-2349
- Reclutamiento
- Emerson Clinical Research- Virginia Retina Specialists
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Washington
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Bellevue, Washington, Estados Unidos, 98004-3779
- Reclutamiento
- Vitreoretinal Associates of Washington
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Silverdale, Washington, Estados Unidos, 98383
- Reclutamiento
- Retina Center NW PLLC
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Spokane, Washington, Estados Unidos, 99204-2509
- Reclutamiento
- Spokane Eye Clinic (OCT and optical exam
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Tokyo
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Meguro-ku, Tokyo, Japón, 152-8902
- Reclutamiento
- Tokyo Medical Center - Ophthalmology
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Riga
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Riga, Riga, Letonia, LV-1009
- Reclutamiento
- Latvian American Eye Center
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Masovian Voivodeship
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Kraków, Masovian Voivodeship, Polonia, 30-363
- Reclutamiento
- Szpital sw. Rozy Sp. z o.o.
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Warmian-Masurian Voivodeship
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Olsztyn, Warmian-Masurian Voivodeship, Polonia, 10-424
- Reclutamiento
- Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Men or women ≥ 50 years old, capable of giving signed informed consent
- Active, treatment-naïve subfoveal CNV lesions secondary to nAMD including juxtafoveal lesions that affect the fovea as confirmed by SD-OCT and FA in the study eye (SE)
- Total area of CNV (including both classic and occult components) > 50% of the total lesion area in the SE
- The BCVA letter score ≥ 24 and ≤ 78 letters, in the SE
- Presence of intra and/or subretinal fluid affecting the central subfield of the SE as identified by SD-OCT attributable to active CNV. The central subfield is defined as a circle with a diameter of 1 mm, centered on the fovea
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply at either screening or baseline, unless otherwise indicated per protocol:
- Total lesion size > 12 disc areas (30.5 mm2) including blood, scars, and neovascularization, in the study eye
- Scar, fibrosis, or atrophy involving the central subfield in the study eye
- Scar or fibrosis involving > 50% of the total lesion in the study eye
- Presence of retinal pigment epithelium tears or rips involving the macula in the study eye
- History of any vitreous hemorrhage ≤ 4 weeks (28 days) before randomization in the study
- Presence of other causes of CNV, including pathologic myopia (spherical equivalent ≥ 8 diopters negative or axial length ≥ 25 mm), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study
- Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye
- History or clinical evidence of DR, DME, idiopathic autoimmune uveitis, or any other vascular disease affecting the retina, other than nAMD in either eye
- Evidence of active extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening or randomization
- Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Blood pressure needs to be stable for at least 12 weeks (84 days) prior to screening
- Any prior or concomitant ocular or systemic treatment (with an investigational or approved, anti VEGF or anti-VEGF/anti-angiopoietin agent) in the SE, or surgery for nAMD in the SE, except dietary supplements or vitamins
- History or evidence of any other clinically significant disorder, condition, disease or clinical laboratory abnormality that, in the opinion of the investigator or study medical monitor, if consulted, would pose a risk to participant safety or interfere with the study evaluation or results interpretation
- Other protocol-specified exclusion criteria
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: ABP 938 8 mg
Participants will receive intravitreal ABP 938 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with Dose Regimen Adjustment (DRA) decisions beginning at Week 16 based on predefined disease-activity criteria.
Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
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IVT injection
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Comparador activo: Aflibercept (US) 8 mg
Participants will receive intravitreal Aflibercept (US) 8 mg injections at Baseline, Week 4, and Week 8. Participants will then be assessed at scheduled study visits, with DRA decisions beginning at Week 16 based on predefined disease-activity criteria.
Injections will be administered at protocol-defined intervals ranging from every 4 to 16 weeks through the end of the study.
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IVT injection
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Periodo de tiempo: Baseline and Week 12
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Baseline and Week 12
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Percentage of Participants With Absence of Intraretinal Fluid (IRF) and Subretinal Fluid (SRF) in the Center Subfield, as Assessed by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Periodo de tiempo: Week 16
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Week 16
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Change from Baseline in BCVA as measured by ETDRS letter score
Periodo de tiempo: Baseline to Week 48
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Baseline to Week 48
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Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24
Periodo de tiempo: Baseline to Week 24
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Baseline to Week 24
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Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48
Periodo de tiempo: Baseline to Week 48
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Baseline to Week 48
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Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)
Periodo de tiempo: Baseline to Week 48
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Baseline to Week 48
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Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT
Periodo de tiempo: Baseline to Week 48
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Baseline to Week 48
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Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments
Periodo de tiempo: Week 16 and Week 20
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Week 16 and Week 20
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Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments
Periodo de tiempo: Week 48
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Week 48
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Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: Baseline up to Week 48
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Baseline up to Week 48
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Number of Participants Who Experienced Non-Ocular TEAEs
Periodo de tiempo: Baseline up to Week 48
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Baseline up to Week 48
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Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI)
Periodo de tiempo: Baseline up to Week 48
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Baseline up to Week 48
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Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs)
Periodo de tiempo: Baseline up to Week 48
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Baseline up to Week 48
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Number of Participants Who Developed Binding Antidrug Antibodies (ADAs)
Periodo de tiempo: Baseline up to Week 48
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Baseline up to Week 48
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Free serum concentrations of ABP 938 8 mg
Periodo de tiempo: Week 16, week 24 and 48 (End of Study)
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Week 16, week 24 and 48 (End of Study)
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Free serum concentrations of Aflibercept (US) 8 mg
Periodo de tiempo: Week 16, week 24, and 48 (End of Study)
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Week 16, week 24, and 48 (End of Study)
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Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a PK substudy
Periodo de tiempo: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
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From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
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Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose in a PK substudy
Periodo de tiempo: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
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From Baseline (day 1, week 0) to Day 29 (pre dose week 4)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: MD, Amgen
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de mayo de 2026
Finalización primaria (Estimado)
31 de julio de 2027
Finalización del estudio (Estimado)
12 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
22 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
22 de mayo de 2026
Publicado por primera vez (Actual)
29 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
16 de septiembre de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20250115
- 2025 (Subvención/contrato del NIH de EE. UU.: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523500-72-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Marco de tiempo para compartir IPD
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities.
There is no end date for eligibility to submit a data sharing request for this study.
Criterios de acceso compartido de IPD
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).
In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling.
Requests are reviewed by a committee of internal advisors.
If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision.
Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.
This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications.
Further details are available at the URL below.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .