Clinical Trials Logo

Clinical Trial Summary

Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD. The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?

Clinical Trial Description

BCVA: Best-Corrected Visual Acuity Eylea EU: Europe-authorized Eylea® nAMD: Neovascular Age-related Macular Degeneration VEGF: Vascular Endothelium Growth Factor ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04864834
Study type Interventional
Source Sandoz
Contact Sandoz
Phone 1-888-669-6682
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date April 30, 2021
Completion date February 10, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04101877 - The Sahlgrenska Anti-VEGF Study Phase 2
Active, not recruiting NCT03953079 - A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD Phase 2
Active, not recruiting NCT03577899 - Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-1) Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Completed NCT01926977 - Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration Phase 1/Phase 2
Recruiting NCT00370539 - Combined PDT and Intravitreal Bevacizumab vs Combination of PDT, Intravitreal Bevacizumab and Triamcinolone for Neovascular AMD Phase 3
Recruiting NCT03683251 - Extension Study for the Port Delivery System With Ranibizumab (Portal) Phase 3
Recruiting NCT03909425 - Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography
Completed NCT03744767 - Adjuvant Anti-Mineralocorticoid-Receptor Treatment in Anti-VEGF Refractory Neovascular Age-Related Macular Degeneration Phase 2
Recruiting NCT04690556 - Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD Phase 3
Active, not recruiting NCT03677934 - A Phase III Study to Evaluate the Port Delivery System With Ranibizumab Compared With Monthly Ranibizumab Injections in Participants With Wet Age-Related Macular Degeneration Phase 3
Recruiting NCT03594461 - Intense Treatment Regimen With Intravitreal Aflibercept Injection Phase 1/Phase 2
Recruiting NCT04537884 - Safety and Tolerability Study of UBX1325 in Patients With Diabetic Macular Edema or Neovascular Age-Related Macular Degeneration Phase 1
Completed NCT03216538 - Safety and Efficacy of AS101 1% Oral Solution in Patients With Neovascular Age-Related Macular Degeneration (AMD) Phase 1/Phase 2
Completed NCT01958918 - Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD Phase 4
Not yet recruiting NCT04058535 - Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular Age-related Macular Degeneration Phase 1
Recruiting NCT02452840 - Photodynamic Therapy for PDA in NV AMD
Active, not recruiting NCT01918878 - Aflibercept (EYLEA)as Secondary or Third Line Treatment for Neovascular Age-related Macular Degeneration. Phase 4
Completed NCT01712035 - Neovascular Age-related Macular Degeneration
Recruiting NCT03021785 - A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration Phase 1