Ignite Creation Date:
2024-07-17 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492876
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-01
Brief Title:
Gene Therapy for DME
Sponsor:
Frontera Therapeutics
Organization:
Frontera Therapeutics
Study Overview
Official Title:
A Dose-escalation and Dose-expanded Phase III Clinical Study to Evaluate the Safety and Efficacy of FT-003 in Subjects With DME
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The goal of this clinical trial is to evaluate the safety tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema DME The study was divided into two phases Phase 1 dose escalation and Phase II dose expansion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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