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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ABP 938 8 mg

    Drug

    IVT injection

  • Aflibercept (US) 8 mg

    Drug

    IVT injection

Treatment groups

304 Participants
are divided into 2 treatment groups
Group A: ABP 938 8 mgExperimental treatment 1 intervention
Group B: Aflibercept (US) 8 mgActive comparator 1 intervention

Trial outcomes

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

Other outcomes

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