Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05891548
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-02
First Post:
2023-05-24
Brief Title:
Study to Evaluate Suprachoroidally Administered CLS-AX in the Treatment of Neovascular Age-Related Macular Degeneration
Sponsor:
Clearside Biomedical Inc
Organization:
Clearside Biomedical Inc
Study Overview
Official Title:
ODYSSEY A Phase 2b Study of Suprachoroidally Administered CLS-AX in Participants With Neovascular Age-Related Macular Degeneration
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ODYSSEY
Brief 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 10 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 10 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None