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
Phase 3Interventional Study
Neovascular Age-related Macular DegenerationnAMD
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
304 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for
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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)
Trial Locations
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Eligibility Criteria
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 …
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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