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A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered via Intravitreal Injection in Participants with Neovascular Age-related Macular Degeneration

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523500-72-00
Enrollment
99
Registered
2026-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related Macular Degeneration (nAMD)

Brief summary

Change from baseline in BCVA as measured by ETDRS letter score at XXX

Detailed description

01 Proportion of participants with no IRF and no SRF in the center subfield at XXX, 02 Change from baseline in BCVA as measured by ETDRS letter score over the study duration, 03 Proportion of participants gaining at least 15 letters in BCVA from baseline at XXX, 04 Proportion of participants gaining at least 15 letters in BCVA from baseline at XXX, 05 Change from baseline in CNV area size, as measured by FA, and CST, as measured by SD-OCT, over the study duration, 06 Proportion of participants who met protocol-defined XXX criteria at XXX or XXX, 07 Proportion of participants who met protocol-defined XXX criteria through XXX, 08 Secondary safety endpoint: TEAEs (ocular and non-ocular), treatment-emergent EOIs, and TESAEs over the study duration, 09 Other secondary endpoint: Incidence of ADAs over the study duration, 10 Other secondary endpoint: Free serum concentrations by visit through EoS (all participants) and the PK parameters from concentration time profiles following first dose in a PK substudy

Interventions

DRUGEylea 114.3 mg/mL
DRUGAflibercept Biosimilar

Sponsors

Amgen Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in BCVA as measured by ETDRS letter score at XXX

Secondary

MeasureTime frame
01 Proportion of participants with no IRF and no SRF in the center subfield at XXX, 02 Change from baseline in BCVA as measured by ETDRS letter score over the study duration, 03 Proportion of participants gaining at least 15 letters in BCVA from baseline at XXX, 04 Proportion of participants gaining at least 15 letters in BCVA from baseline at XXX, 05 Change from baseline in CNV area size, as measured by FA, and CST, as measured by SD-OCT, over the study duration, 06 Proportion of participants who met protocol-defined XXX criteria at XXX or XXX, 07 Proportion of participants who met protocol-defined XXX criteria through XXX, 08 Secondary safety endpoint: TEAEs (ocular and non-ocular), treatment-emergent EOIs, and TESAEs over the study duration, 09 Other secondary endpoint: Incidence of ADAs over the study duration, 10 Other secondary endpoint: Free serum concentrations by visit through EoS (all participants) and the PK parameters from concentration time profiles following first dose in

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 19, 2026