NCT05282004

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Vial Kit

An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Vial Kit

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.

Detailed description

Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea USPI, which recommends a dose of 2 mg aflibercept (0.05 mL) administered by IVT injection. Only subjects already under IVT Eylea treatment and hence familiar with the IVT procedure were eligible for the study. Administration of the study treatment was embedded into their routine treatment scheme.

Conditions

• Neovascular Age-related Macular Degeneration (nAMD)

Interventions

Type	Name	Description
DRUG	SOK583A1	SOK583A1 will be provided in a vial kit, with 40 mg/mL of aflibercept solution for IVT injection (2 mg/0.05 mL)

Timeline

• Start date: 2022-05-16
• Primary completion: 2022-09-07
• Completion: 2022-09-07
• First posted: 2022-03-16
• Last updated: 2023-05-10
• Results posted: 2023-05-10

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study