Neovascular Age-related Macular Degeneration (nAMD)
Conditions
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
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in BCVA as measured by ETDRS letter score at XXX | — |
Secondary
| Measure | Time 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 | — |