Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05699759
Status:
COMPLETED
Last Update Posted:
2024-11-01
First Post:
2022-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effect of Intravitreal Injection of a Derivative of Nucleoside Reverse Transcriptase Inhibitor in Subjects with Diabetic Macular Edema
Sponsor:
Michelle Abou-Jaoude
Organization:
Study Overview
Official Title:
A Non-randomized, Open Label, Safety and Efficacy Study Evaluating a Single Dose of Kamuvudine-8 (K8) for the Treatment of Patients with Diabetic Macular Edema
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This study is designed to assess the safety and initial evidence of efficacy of the novel compound SOM-401 (K8), a derivative of a nucleoside reverse transcriptase inhibitor, in subjects with untreated, clinically significant, diabetic macular edema (DME).
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: