RecruitingPhase 3NCT07614776

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

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


Sponsor

Amgen

Enrollment

304 participants

Start Date

May 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 50 Years

Inclusion Criteria5

  • 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 Criteria13

  • 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

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Interventions

DRUGABP 938 8 mg

IVT injection

DRUGAflibercept (US) 8 mg

IVT injection


Locations(18)

South Coast Retina Center - RCA

Long Beach, California, United States

California Eye Specialists Medical Group, Inc

Pasadena, California, United States

Retina Consultants of San Diego

Poway, California, United States

Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)

Sacramento, California, United States

Retina Group of Florida

Fort Lauderdale, Florida, United States

Medeye Associates - Research

Miami, Florida, United States

Advanced Research, LLC

Pensacola, Florida, United States

Retina Associates

Elmhurst, Illinois, United States

Retina Consultants of Minnesota

Edina, Minnesota, United States

Mississippi Retina Assoc

Madison, Mississippi, United States

Charleston Neuroscience Institute

Charleston, South Carolina, United States

Retina Consultants of South Carolina, Charleston Neuroscience Institute- Ladson (RCA)

Ladson, South Carolina, United States

Palmetto Retina Center, Florence (RCA)

West Columbia, South Carolina, United States

Texas Retina Associates (TRA) - Arlington

Arlington, Texas, United States

Texas Retina Associates (TRA) - Dallas Main

Dallas, Texas, United States

Texas Retina Associates - Fort Worth

Fort Worth, Texas, United States

Retina Consultants of Texas - Schertz

Schertz, Texas, United States

Vitreoretinal Associates of Washington

Bellevue, Washington, United States

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NCT07614776


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