NCT05891548

Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration

ODYSSEY: A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	CLS-AX	CLS-AX will be administered by suprachoroidal injection into the study eye on Day 1 and then every 12 to 24 weeks as determined by protocol-defined disease activity criteria.
DRUG	Aflibercept	Aflibercept will be administered by intravitreal injection into the study eye once every 8 weeks (Q8W).

Timeline

• Start date: 2023-05-31
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2023-06-07
• Last updated: 2025-07-25

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study