Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04603937
Status:
TERMINATED
Last Update Posted:
2023-10-02
First Post:
2020-10-21
Brief Title:
A Study to Evaluate the Efficacy Durability and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema DME
Sponsor:
Kodiak Sciences Inc
Organization:
Kodiak Sciences Inc
Study Overview
Official Title:
A Prospective Randomized Double-masked Active Comparator-controlled Multi-center Two-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema DME
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study did not meet primary endpoint
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLIMMER
Brief Summary:
This Phase 3 study will evaluate the efficacy durability and safety of KSI-301 compared to aflibercept in participants with treatment-naïve DME
Detailed Description:
This is a Phase 3 prospective randomized double-masked two-arm multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with treatment-naïve DME
The primary endpoint will be assessed at Year 1 additional secondary endpoints for efficacy will be assessed at Years 1 and 2
The primary endpoint will be assessed at Year 1 additional secondary endpoints for efficacy will be assessed at Years 1 and 2
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-001063-82 | EUDRACT_NUMBER | None | None |