Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722991
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2021-01-22
Brief Title:
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase 2 Randomized Placebo-controlled Double-masked Proof-of-concept Study to Investigate the Efficacy and Safety of Runcaciguat BAY 1101042 in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
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:
NEON-NPDR
Brief Summary:
This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy To assess efficacy the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score or DRSS Two-step DRSS improvement at 24 weeks of treatment will be the primary efficacy endpoint DRSS assessments are repeated after completion of 48 weeks of treatment In addition vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002333-15 | EUDRACT_NUMBER | None | None |