Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06270836
Status:
RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-02-14
Brief Title:
A Study to Evaluate the Efficacy and Safety of Tarcocimab Tedromer Compared With Sham Treatment in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy NPDR
Sponsor:
Kodiak Sciences Inc
Organization:
Kodiak Sciences Inc
Study Overview
Official Title:
A Prospective Randomized Double-masked Sham-controlled Multi-center Two-arm Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal Tarcocimab Tedromer in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy NPDR - GLOW2
Status:
RECRUITING
Status Verified Date:
2024-09
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:
GLOW2
Brief Summary:
This study will demonstrate that tarcocimab 5 mg is superior to sham treatment in participants with moderately severe to severe NPDR
Detailed Description:
This is a prospective randomized double-masked two-arm multi-center Phase 3 study to demonstrate that tarcocimab 5 mg is superior to sham treatment with respect to the proportion of eyes improving from baseline at Week 48 in participants with moderately severe to severe NPDR
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