NCT04626128

Safety and Tolerability Study of Suprachoroidal Injection of CLS-AX Following Anti-VEGF Therapy in Neovascular AMD

OASIS: Open-label, Dose-escalation, Phase 1/2a Study of the Safety and Tolerability of Suprachoroidally Administered CLS-AX Following Intravitreal Anti-VEGF Therapy in Subjects With Neovascular Age-related Macular Degeneration

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in subjects with neovascular age-related macular degeneration (AMD)

Detailed description

Multi-center, open-label, dose-escalation, phase 1/2a, safety and tolerability study to evaluate four dose groups of suprachoroidally administered CLS-AX following intravitreal anti-VEGF therapy in up to a maximum of 25 subjects with neovascular age-related macular degeneration

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	CLS-AX	injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
DRUG	Anti-VEGF	Standard of care therapy used to block vascular endothelial growth factor

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-10-13
• Completion: 2022-10-13
• First posted: 2020-11-12
• Last updated: 2023-09-18
• Results posted: 2023-08-21

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study