Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05038020
Status:
TERMINATED
Last Update Posted:
2023-11-01
First Post:
2021-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Sponsor:
Alkahest, Inc.
Organization:
Study Overview
Official Title:
A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to safety findings in other AKST4290 studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).
Detailed Description:
This study is designed to evaluate the efficacy of AKST4290 administered at a total daily dose (TDD) of 800 mg daily (400 mg twice daily \[b.i.d.\]) compared with placebo over a 24-week dosing period in participants with moderately severe non-proliferative diabetic retinopathy (NPDR) to severe NPDR.
Participants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (AKST4290: placebo). Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily (400 mg b.i.d.) in Arm 1 or placebo (matching tablets) in Arm 2
Participants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (AKST4290: placebo). Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily (400 mg b.i.d.) in Arm 1 or placebo (matching tablets) in Arm 2
Study Oversight
Has Oversight DMC:
False
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?: