Comparing ABP 938 With Aflibercept Eye Injections for Neovascular Age-Related Macular Degeneration

Trial details

Who runs it

Amgen

Trial code

NCT07614776EU 2025-523500-72-00

Record updated

14 October 2026

Original description

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)Read full original descriptionShow less

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)

Inclusion: 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: Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye; 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 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; 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; 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; 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; Other protocol-specified exclusion criteria.

ClinicalTrials.gov NCT07614776 · EU CTIS 2025-523500-72-00