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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorAmgen

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

304 Participants
are divided into 2 treatment groups

Sponsors and collaborators