At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
SOK583A1 (40 mg/mL) +1 moredrug
Likely dose
SOK583A1 (40 mg/mL)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SOK583A1 (40 mg/mL) and Prefilled Syringe (PFS) for Neovascular Age-related Macular Degeneration (nAMD). Completed, enrolled 30 participants across 3 sites.
Detailed Summary
This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedDec 2021
Enrollment StartMar 2022
Primary CompletionMay 2022
TodayJul 2026
First PostedDec 17, 2021
Enrollment StartMar 11, 2022
Primary CompletionMay 4, 2022
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 4.5 years ago
Interventions
SOK583A1 (40 mg/mL)drug
SOK583A1 provided in a Prefilled Syringe (PFS), which includes 2 mg aflibercept in 0.05 mL for IVT administration
Prefilled Syringe (PFS)device
Prefilled Syringe (PFS)