CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
SOK583A1drug
Likely dose
SOK583A1 2 mg/0.05 mL via intraocular injectionAI-extracted
Key inclusion· 3
  • ✓Age ≥50 years at baseline
  • ✓Diagnosed with neovascular age-related macular degeneration (uni- or bilateral)
  • ✓Already receiving intraocular aflibercept (Eylea) treatment at induction or maintenance phase
Key exclusion· 9
  • ✕Active, suspected, or recent (within 4 weeks) intraocular inflammation of clinical significance (including infections, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis)
  • ✕Uncontrolled ocular hypertension or glaucoma (IOP ≥26 mmHg despite anti-glaucomatous medication)
  • ✕Visual acuity worse than 20/200 (legal blindness level)
  • ✕Topical ocular corticosteroids for ≥30 consecutive days within 3 months prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05282004
NCT05282004Phase 3Completed
CompareCT.gov

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

Sandoz·interventional·Posted Mar 16, 2022·Updated May 10, 2023

In Brief

A Phase 3 clinical trial evaluating SOK583A1 for Neovascular Age-related Macular Degeneration (nAMD). Completed, enrolled 36 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeovascular Age-related Macular Degeneration (nAMD)
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedMar 16, 2022
Enrollment StartMay 16, 2022
Primary CompletionSep 7, 2022
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 4.3 years ago

Interventions

SOK583A1drug

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