Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06181227
Status:
TERMINATED
Last Update Posted:
2024-04-24
First Post:
2023-11-28
Brief Title:
A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema
Sponsor:
Aviceda Therapeutics Inc
Organization:
Aviceda Therapeutics Inc
Study Overview
Official Title:
A Phase 2 Study to Evaluate the Safety and Treatment Effect of Intravitreal AVD-104 in Participants With Diabetic Macular Edema
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 2 study to determine the safety and preliminary efficacy of intravitreal injections of AVD-104 a novel glyco-mimetic nanoparticle in reducing macular edema associated with diabetic retinopathy
Detailed Description:
The primary objective is to evaluate the tolerability and treatment effect of intravitreal injections IVT of AVD-104 in participants with diabetic macular edema DME Participants will receive either three intravitreal injections of low-dose AVD-104 10 mg each 28 days apart or two intravitreal injections of AVD-104 at a high-dose 20 mg 56 days apart Serial optical coherence tomography OCT ultra wide-field fluorescein angiography and OCT-angiography OCT-A will be performed to evaluate the treatment effect on central subfield thickness CST and areas of non-perfusion All participants will be followed-up for safety until day 84
There will be a planned enrollment up to 30 participants
There will be a planned enrollment up to 30 participants
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