Trial intelligence / Profile preview

ASKG712 in Neovascular Age-related Macular Degeneration

NCT05456828Phase 2

Key facts

Status: Completed
Start: Feb 2023
Primary completion: Nov 2025
Countries: 1
Sponsor: Visara
Modality: Bispecific Antibodies, Fc-Fusion Proteins

Drugs: ASKG712
Conditions: neovascular age-related macular degeneration (NVAMD)

Overview

Phase 2, randomised, open-label trial of ASKG712 in neovascular age-related macular degeneration (NVAMD), sponsored by Visara. Primary endpoints: Incidence of ocular adverse events at 36 weeks and Incidence of non-ocular adverse events at 36 weeks. Started Feb 2023; status: completed.

Design

1 arm

Study design: RandomizedOpen-label

ASKG712
Single or multiple ascending dose of ASKG712 by intravitreal injection

Who it enrols

Patients aged 50-80 with active sub-foveal or juxta-foveal CNV secondary to nAMD, total lesion area <= 12 DA, and BCVA 19-78 letters. Excludes patients with recent anti-VEGF treatment, uveitis, or significant macular scarring.

Endpoints

Primary

Incidence of ocular adverse events36 weeks
Incidence of non-ocular adverse events36 weeks

Secondary

Area under the concentration time curve20 weeks
Maximum plasma concentration20 weeks
Anti-Drug Antibody20 weeks
Best Corrected Visual Acuity36 weeks
Central Subfield Thickness36 weeks
Choroidal Neovascularization Area20 weeks

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