Ignite Creation Date:
2025-12-24 @ 2:47 PM
Ignite Modification Date:
2025-12-29 @ 7:29 PM
Study NCT ID:
NCT07228559
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2025-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Avoralstat In Participants With Diabetic Macular Edema
Sponsor:
BioCryst Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase 1b Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Suprachoroidal Injection of Avoralstat In Participants With Diabetic Macular Edema
Status:
RECRUITING
Status Verified Date:
2025-11
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:
None
Brief Summary:
The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.
Detailed Description:
Study BCX4161-111 is an open-label, single ascending dose study with 24 weeks follow-up in participants with DME. Three cohorts with a minimum of 3 participants enrolled in each cohort with 3 dose levels of avoralstat (low, medium, high) are planned.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: