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

Официальное название

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

Обзор

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)

Вмешательства

• Препарат ABP 938 8 mg
  IVT injection
• Препарат Aflibercept (US) 8 mg
  IVT injection

Первичные конечные точки

• Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score [Срок оценки: Baseline and Week 12]

Вторичные конечные точки (12)

• 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) [Срок оценки: Week 16]
• Change from Baseline in BCVA as measured by ETDRS letter score [Срок оценки: Baseline to Week 48]
• Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24 [Срок оценки: Baseline to Week 24]
• Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48 [Срок оценки: Baseline to Week 48]
• Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA) [Срок оценки: Baseline to Week 48]
• Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT [Срок оценки: Baseline to Week 48]
• Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments [Срок оценки: Week 16 and Week 20]
• Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments [Срок оценки: Week 48]
• Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Baseline up to Week 48]
• Number of Participants Who Experienced Non-Ocular TEAEs [Срок оценки: Baseline up to Week 48]
• Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI) [Срок оценки: Baseline up to Week 48]
• Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs) [Срок оценки: Baseline up to Week 48]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 36 центров

• Retina Consultants of Orange County — Fullerton
• South Coast Retina Center - RCA — Long Beach
• Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA) — Modesto
• California Eye Specialists Medical Group, Inc — Pasadena
• Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA) — Sacramento
• California Retina Consultants — Santa Barbara
• Retina Consultants of Southern Colorado (Colorado Springs)- RCA — Colorado Springs
• Retina Group of New England — Waterford
• … и ещё 28 центров

Идентификаторы

NCT: NCT07614776 · 20250115 · 2025-523500-72-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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