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NCT Number: 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

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)

Recruiting

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retina Consultants of Orange County, Fullerton, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABP 938 8 mg

Drug

IVT injection

Aflibercept (US) 8 mg

Drug

IVT injection

Other names: EYLEA HD

Primary outcomes

  1. Change From Baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score

    Time frame: Baseline and Week 12

Secondary outcomes

  1. 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)

    Time frame: Week 16

  2. Change from Baseline in BCVA as measured by ETDRS letter score

    Time frame: Baseline to Week 48

  3. Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 24

    Time frame: Baseline to Week 24

  4. Percentage of Participants Who Gained at Least 15 Letters of Vision From Baseline to Week 48

    Time frame: Baseline to Week 48

  5. Change From Baseline in Choroidal Neovascularization (CNV) Area Size as Measured by Fluorescein Angiography (FA)

    Time frame: Baseline to Week 48

  6. Change From Baseline in Central Subfield Thickness (CST) as Measured by SD-OCT

    Time frame: Baseline to Week 48

  7. Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments

    Time frame: Week 16 and Week 20

  8. Percentage of Participants Who Met Protocol-Defined DRA Criteria, as Determined by Protocol-Specified Clinical and Imaging Assessments

    Time frame: Week 48

  9. Number of Participants Who Experienced Ocular Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Baseline up to Week 48

  10. Number of Participants Who Experienced Non-Ocular TEAEs

    Time frame: Baseline up to Week 48

  11. Number of Participants Who Experienced Treatment-Emergent Events of Interest (EOI)

    Time frame: Baseline up to Week 48

  12. Number of Participants Who Experienced Treatment-Emergent Serious Adverse Events (TESAEs)

    Time frame: Baseline up to Week 48

  13. Number of Participants Who Developed Binding Antidrug Antibodies (ADAs)

    Time frame: Baseline up to Week 48

  14. Free serum concentrations of ABP 938 8 mg

    Time frame: Week 16, week 24 and 48 (End of Study)

  15. Free serum concentrations of Aflibercept (US) 8 mg

    Time frame: Week 16, week 24, and 48 (End of Study)

  16. Pharmacokinetic (PK) parameters of ABP 938 8mg derived from concentration - time profiles following the first dose in a PK substudy

    Time frame: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)

  17. Pharmacokinetic parameters of Aflibercept (US) 8 mg derived from concentration - time profiles following the first dose in a PK substudy

    Time frame: From Baseline (day 1, week 0) to Day 29 (pre dose week 4)

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 29, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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