Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05038020
Status:
TERMINATED
Last Update Posted:
2023-11-01
First Post:
2021-07-29
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:
Alkahest Inc
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 bid 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 21 randomization scheme AKST4290 placebo Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily 400 mg bid in Arm 1 or placebo matching tablets in Arm 2
Participants will be enrolled and allocated to 1 of 2 treatment arms in a 21 randomization scheme AKST4290 placebo Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily 400 mg bid in Arm 1 or placebo matching tablets in Arm 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