Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412224
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-24
Brief Title:
The Preliminary Safety and Efficacy of RRG001 After Vitrectomy in Subjects With Proliferative Diabetic Retinopathy PDR
Sponsor:
Li Xiaorong
Organization:
Tianjin Medical University Eye Hospital
Study Overview
Official Title:
An Exploratory ITTInvestigator Initiated Study Study to Evaluate the Preliminary Safety and Efficacy of Single Subretinal Injection of RRG001 at the End of or After Vitrectomy in Subjects With PDR
Status:
RECRUITING
Status Verified Date:
2024-05
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 aims to slow down disease progression reduce postoperative complications and decrease retreatment frequency in subjects with proliferative diabetic retinopathy PDR by administering a single subretinal injection of RRG001 gene therapy after vitrectomy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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