RecruitingNeovascular Age-related Macular DegenerationnAMD

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

Eligible age

50+ yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

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About this study

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)

Sponsor: Amgen

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