NCT05161806

Study of the Safety of Use of Intravitreal SOK583A1 Provided in a Prefilled Syringe

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 Prefilled Syringe

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.

Detailed description

This was an open-label, single arm, multicenter, Phase IIIb study in subjects with nAMD, eligible for Intravitreal (IVT) aflibercept treatment. Screening and Baseline could be performed on the same day. Subjects with nAMD received a single dose of study treatment (2 mg SOK583 in 0.05 mL) in line with the Eylea US PI, 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 individual dosing schedule. Demonstration of the safe use of the PFS containing SOK583A1 was based on the performance of at least 3 different ophthalmologist teams. Follow-up visits were performed on-site on Day 8 (±2 days) and on Day 31 (+4 days - end of study visit). Subjects participated for 30 to 34 days in the study including Baseline and treatment on Day 1 (Screening and Baseline could be performed on the same day) and the last safety follow-up on Day 31 (a time window of plus 4 days was allowed for the last safety follow-up).

Conditions

• Neovascular Age-related Macular Degeneration (nAMD)

Interventions

Type	Name	Description
DRUG	SOK583A1 (40 mg/mL)	SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration
DEVICE	Prefilled Syringe (PFS)	Prefilled Syringe (PFS)

Timeline

• Start date: 2022-03-11
• Primary completion: 2022-05-04
• Completion: 2022-05-04
• First posted: 2021-12-17
• Last updated: 2022-11-18
• Results posted: 2022-11-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study