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

Neovascular Age-related Macular Degeneration (nAMD) Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05282004
Study type Interventional
Source Sandoz
Contact
Status Completed
Phase Phase 3
Start date May 16, 2022
Completion date September 7, 2022
View Details
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