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

Recruiting now · Phase 3

Conditions studied: Neovascular Age-related Macular Degeneration, nAMD

In brief

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)

Key facts

Study ID

NCT07614776

Run by

Amgen

People needed

304

Starts

2026-05-27

Expected to finish

2028-01-12

Last updated by the study team

2026-07-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Retina Consultants of Orange County — Fullerton, California, United States (enrolling)
• South Coast Retina Center - RCA — Long Beach, California, United States (enrolling)
• Retinal Consultants Medical Group, Inc.-Sacramento, Greenback Lane, (RCA) — Modesto, California, United States (enrolling)
• California Eye Specialists Medical Group, Inc — Pasadena, California, United States (enrolling)
• Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA) — Sacramento, California, United States (enrolling)
• California Retina Consultants — Santa Barbara, California, United States (enrolling)
• Retina Consultants of Southern Colorado (Colorado Springs)- RCA — Colorado Springs, Colorado, United States (enrolling)
• Retina Group of New England — Waterford, Connecticut, United States (enrolling)
• Medeye Associates - Research — Miami, Florida, United States (enrolling)
• Retina Consultants of Southwest Florida - Naples — Naples, Florida, United States (enrolling)
• Advanced Research, LLC — Pensacola, Florida, United States (enrolling)
• Retina Associates — Elmhurst, Illinois, United States (enrolling)
• Associated Vitreoretinal and Uveitis Consultants — Carmel, Indiana, United States (enrolling)
• Mid Atlantic Retina Specialists — Hagerstown, Maryland, United States (enrolling)
• Retina Specialists — Towson, Maryland, United States (enrolling)
• Retina Consultants of Minnesota — Edina, Minnesota, United States (enrolling)
• Mississippi Retina Assoc — Madison, Mississippi, United States (enrolling)
• The Retina Institute, Research Retina Institute (RCA) — St Louis, Missouri, United States (enrolling)
• Vision Research Center Eye Associates of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• Ophthalmic Consultants of Long Island - Research — Oceanside, New York, United States (enrolling)
• NC Retina Associates-RCA — Wake Forest, North Carolina, United States (enrolling)
• Retina Consultants of South Carolina, Charleston Neuroscience institute - Blufffon (RCA) — Beaufort, South Carolina, United States (enrolling)
• Charleston Neuroscience Institute — Charleston, South Carolina, United States (enrolling)
• Palmetto Retina Center - Main (RCA) — Columbia, South Carolina, United States (enrolling)
• Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA) — Ladson, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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