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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

RecruitingPhase 3Ages 50 Years - anyAllAmgen
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • ABP 938 8 mg
  • Aflibercept (US) 8 mg
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Where

81 sites
Retina Consultants of Orange County
Fullerton, United States
South Coast Retina Center - RCA
Long Beach, United States
Retinal Consultants Medical Group, Inc - Modesto (RCA)
Modesto, United States
California Eye Specialists Medical Group, Inc
Pasadena, United States
Retinal Consultants Medical Group, Inc - Sacramento - Parkcenter Drive (RCA)
Sacramento, United States
California Retina Consultants
Santa Barbara, United States
Retina Consultants of Southern Colorado (Colorado Springs)- RCA
Colorado Springs, United States
Retina Consultants of Southern Colorado (Pueblo)- RCA
Colorado Springs, United States

…and 73 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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