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 septembre 2026 mis à jour par: 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)
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
304
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Amgen Call Center
- Numéro de téléphone: 866-572-6436
- E-mail: medinfo@amgen.com
Lieux d'étude
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Tokyo
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Meguro-ku, Tokyo, Japon, 152-8902
- Recrutement
- Tokyo Medical Center - Ophthalmology
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Riga
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Riga, Riga, Lettonie, LV-1009
- Recrutement
- Latvian American Eye Center
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Masovian Voivodeship
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Kraków, Masovian Voivodeship, Pologne, 30-363
- Recrutement
- Szpital sw. Rozy Sp. z o.o.
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Warmian-Masurian Voivodeship
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Olsztyn, Warmian-Masurian Voivodeship, Pologne, 10-424
- Recrutement
- Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
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Košice Region
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Trebišov, Košice Region, Slovaquie, 075 01
- Recrutement
- NsP Trebisov, a.s. - Ocne oddelenie
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Trenčín Region
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Trenčín, Trenčín Region, Slovaquie, 911 71
- Recrutement
- Fakultna nemocnica Trencin - Ocna klinika
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Žilina Region
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Žilina, Žilina Region, Slovaquie, 012 07
- Recrutement
- Fakultna nemocnica s poliklinikou Zilina - Ocne oddelenie
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Hradec Králové Region
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Náchod, Hradec Králové Region, Tchéquie, 547 01
- Recrutement
- Visus, spol. s r.o. - Nachod
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Prague
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Prague, Prague, Tchéquie, 150 00
- Recrutement
- AXON clinical
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Stredoceský Kraj
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Mladá Boleslav, Stredoceský Kraj, Tchéquie, 293 01
- Recrutement
- Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje - Klaudianova nemocnice
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California
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Fullerton, California, États-Unis, 92835-3432
- Recrutement
- Retina Consultants of Orange County
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Long Beach, California, États-Unis, 90607
- Recrutement
- South Coast Retina Center - RCA
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Modesto, California, États-Unis, 95356
- Recrutement
- Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA)
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Pasadena, California, États-Unis, 91107
- Recrutement
- California Eye Specialists Medical Group, Inc
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Sacramento, California, États-Unis, 95825
- Recrutement
- Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
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Santa Barbara, California, États-Unis, 93103
- Recrutement
- California Retina Consultants
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Colorado
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Colorado Springs, Colorado, États-Unis, 80909-1183
- Recrutement
- Retina Consultants of Southern Colorado (Colorado Springs)- RCA
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Colorado Springs, Colorado, États-Unis, 80909
- Recrutement
- Retina Consultants of Southern Colorado (Pueblo)- RCA
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Lakewood, Colorado, États-Unis, 80228
- Recrutement
- Colorado Retina Associates (RCA)
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Connecticut
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Waterford, Connecticut, États-Unis, 06385
- Recrutement
- Retina Group of New England
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Florida
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Miami, Florida, États-Unis, 33143
- Recrutement
- Medeye Associates - Research
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Naples, Florida, États-Unis, 34103-4457
- Recrutement
- Retina Consultants of Southwest Florida - Naples
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Pensacola, Florida, États-Unis, 32503
- Recrutement
- Advanced Research, LLC
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Illinois
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Elmhurst, Illinois, États-Unis, 60126
- Recrutement
- Retina Associates
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Oak Forest, Illinois, États-Unis, 60452
- Recrutement
- University Retina - Bedford Park Location
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Indiana
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Carmel, Indiana, États-Unis, 46032
- Recrutement
- Associated Vitreoretinal and Uveitis Consultants
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Maryland
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Baltimore, Maryland, États-Unis, 21209
- Recrutement
- The Retina Care Center- Baltimore (PRISM Vision Group)
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Hagerstown, Maryland, États-Unis, 21740-5846
- Recrutement
- Mid Atlantic Retina Specialists
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Towson, Maryland, États-Unis, 21204
- Recrutement
- Retina Specialists
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Ophthalmic Consultants of Boston
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Minnesota
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Edina, Minnesota, États-Unis, 55435
- Recrutement
- Retina Consultants of Minnesota
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Mississippi
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Madison, Mississippi, États-Unis, 39110
- Recrutement
- Mississippi Retina Assoc
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Missouri
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St Louis, Missouri, États-Unis, 63128
- Recrutement
- The Retina Institute, Research Retina Institute (RCA)
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New Jersey
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Bloomfield, New Jersey, États-Unis, 07003
- Recrutement
- Envision Ocular, LLC
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New Mexico
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Albuquerque, New Mexico, États-Unis, 87109
- Recrutement
- Vision Research Center Eye Associates of New Mexico
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New York
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Liverpool, New York, États-Unis, 13088
- Recrutement
- Retina Vitreous Surgeons of CNY, PC
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Oceanside, New York, États-Unis, 11572
- Recrutement
- Ophthalmic Consultants of Long Island - Research
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North Carolina
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Raleigh, North Carolina, États-Unis, 27607-7514
- Recrutement
- North Carolina Retina Associates
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Wake Forest, North Carolina, États-Unis, 27587
- Recrutement
- NC Retina Associates-RCA
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Ohio
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Dublin, Ohio, États-Unis, 43016
- Recrutement
- Midwest Retina - Main Office
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Pennsylvania
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Kingston, Pennsylvania, États-Unis, 18704-4801
- Recrutement
- Eye Care Specialists - Kingston
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South Carolina
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Beaufort, South Carolina, États-Unis, 29902
- Recrutement
- Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA)
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Charleston, South Carolina, États-Unis, 29414-5896
- Recrutement
- Charleston Neuroscience Institute
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Columbia, South Carolina, États-Unis, 29169
- Recrutement
- Palmetto Retina Center - Main (RCA)
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Ladson, South Carolina, États-Unis, 29456
- Recrutement
- Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)
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Mt. Pleasant, South Carolina, États-Unis, 29464
- Recrutement
- Retina Consultants of South Carolina, Charleston Neuroscience Institute- Mount Pleasant (RCA)
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West Columbia, South Carolina, États-Unis, 29169
- Recrutement
- Palmetto Retina Center, Florence (RCA)
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Tennessee
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- Tennessee Retina PC
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Texas
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Arlington, Texas, États-Unis, 76012
- Recrutement
- Texas Retina Associates (TRA) - Arlington
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Austin, Texas, États-Unis, 78705
- Recrutement
- Austin Retina Associates
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Austin, Texas, États-Unis, 78705
- Recrutement
- Austin Retina Associates - Ophthalmology/Retina
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Bellaire, Texas, États-Unis, 77401
- Recrutement
- Retina Consultants of Texas - Bellaire
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Dallas, Texas, États-Unis, 75231
- Recrutement
- Texas Retina Associates (TRA) - Dallas Main
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Fort Worth, Texas, États-Unis, 76104
- Recrutement
- Texas Retina Associates - Fort Worth
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Houston, Texas, États-Unis, 77401
- Recrutement
- Retina Consultants of Texas - Katy Retina Center
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Katy, Texas, États-Unis, 77494
- Recrutement
- Retina Consultants of Texas - The Woodlands
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San Antonio, Texas, États-Unis, 78240
- Recrutement
- Retinal Consultants of Texas- San Antonio
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Schertz, Texas, États-Unis, 78154
- Recrutement
- Retina Consultants of Texas - Schertz
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Willow Park, Texas, États-Unis, 76087
- Recrutement
- Strategic Clinical Research Group, LLC
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Utah
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Salt Lake City, Utah, États-Unis, 84107
- Recrutement
- Retina Associates of Utah - Retina Specialist
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Virginia
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Falls Church, Virginia, États-Unis, 22042-2349
- Recrutement
- Emerson Clinical Research- Virginia Retina Specialists
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Washington
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Bellevue, Washington, États-Unis, 98004-3779
- Recrutement
- Vitreoretinal Associates of Washington
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Silverdale, Washington, États-Unis, 98383
- Recrutement
- Retina Center NW PLLC
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Spokane, Washington, États-Unis, 99204-2509
- Recrutement
- Spokane Eye Clinic (OCT and optical exam
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Comparateur actif: 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
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Délai: Baseline and Week 12
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Baseline and Week 12
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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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)
Délai: Week 16
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Week 16
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Change from Baseline in BCVA as measured by ETDRS letter score
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: Week 48
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Week 48
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Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: MD, Amgen
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 mai 2026
Achèvement primaire (Estimé)
31 juillet 2027
Achèvement de l'étude (Estimé)
12 janvier 2028
Dates d'inscription aux études
Première soumission
22 mai 2026
Première soumission répondant aux critères de contrôle qualité
22 mai 2026
Première publication (Réel)
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 septembre 2026
Dernière vérification
1 août 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 20250115
- 2025 (Subvention/contrat des NIH des États-Unis: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523500-72-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Délai de partage 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.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .