- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07614776
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
22. maj 2026 opdateret af: 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)
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
304
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Amgen Call Center
- Telefonnummer: 866-572-6436
- E-mail: medinfo@amgen.com
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Aktiv komparator: 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
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Tidsramme: Baseline and Week 12
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Baseline and Week 12
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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)
Tidsramme: Week 16
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Week 16
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Change from Baseline in BCVA as measured by ETDRS letter score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 48
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Week 48
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Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: MD, Amgen
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juni 2026
Primær færdiggørelse (Anslået)
3. august 2027
Studieafslutning (Anslået)
17. januar 2028
Datoer for studieregistrering
Først indsendt
22. maj 2026
Først indsendt, der opfyldte QC-kriterier
22. maj 2026
Først opslået (Faktiske)
29. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20250115
- 2025-523500-72-00 (Ctis)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD-delingstidsramme
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.
IPD-delingsadgangskriterier
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.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med ABP 938 8 mg
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AmgenParexelAfsluttetNeovaskulær (våd) aldersrelateret makuladegeneration (AMD)Spanien, Forenede Stater, Serbien, Israel, Canada, Tjekkiet, Tyskland, Ungarn, Polen, Hong Kong, Italien, Japan, Letland, Mexico, Estland, Litauen, Slovakiet, Sydkorea
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AmgenAfsluttetChorioretinal vaskulær sygdomForenede Stater
-
Juventas Therapeutics, Inc.AfsluttetKritisk lemmeriskæmiForenede Stater, Indien
-
Nantes University HospitalIkke rekrutterer endnu
-
Yeungnam University College of MedicineBayerRekrutteringPolypoid choroidal vaskulopati | Polypoid choroidal vaskulopati (PCV)Sydkorea
-
Association for Innovation and Biomedical Research...Ikke rekrutterer endnu
-
Savient PharmaceuticalsAfsluttetKronisk gigt resistent over for konventionel terapiForenede Stater
-
Viatris Innovation GmbHAfsluttetAkut myokardieinfarktSchweiz, Israel, Belgien
-
TransThera Sciences (Nanjing), Inc.RekrutteringCholangiocarcinomKorea, Republikken, Spanien, Forenede Stater, Taiwan, Italien, Frankrig, Belgien, Tyskland, Portugal, Det Forenede Kongerige, Østrig, Polen, Holland