Clinical Trials Logo

Clinical Trial Summary

Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-vascular endothelial growth factor (VEGF) standard of care therapy. Only one eye will be chosen as the study eye.


Clinical Trial Description

Phase 2b, randomized, double-masked, parallel-group, active-controlled, multicenter, 36-week study designed to assess the safety and efficacy of suprachoroidally administered CLS-AX 1.0 mg with a flexible dosing regimen in participants with neovascular age-related macular degeneration previously treated with intravitreal anti-VEGF standard of care therapy. Active-control will be 2 mg intravitreal injections of aflibercept dosed per the EYLEA Prescribing Information. Only one eye will be chosen as the study eye. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05891548
Study type Interventional
Source Clearside Biomedical, Inc.
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 31, 2023
Completion date July 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04101877 - The Sahlgrenska Anti-VEGF Study Phase 2
Completed NCT03953079 - A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD Phase 2
Terminated NCT03577899 - Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (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
Completed 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
Completed NCT05281042 - Home OCT Repeatability and Reproducibility of Automatic Fluid Quantification Study
Completed 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
Completed NCT05131646 - Extension Study to Evaluate the Long-term Outcomes of Subjects in the CLS-AX CLS1002-101 Study
Completed 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 NCT04304755 - Zoledronic Acid as Adjuvant Therapy in Neovascular Age-related Macular Degeneration (Z-AMD) 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
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