Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559488
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Intravitreal Bevacizumab Intraoperatively in The Prevention of Early Recurrent Vitreous Hemorrhage Post-Vitrectomy in Diabetic Vitreous Hemorrhage
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Recurrent vitreous hemorrhage following pars plana vitrectomy PPV for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75 Early and late recurrences are associated with various factors including residual blood fibrovascular tissue and neovascularization Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents gas tamponade and peripheral cryotherapy the outcomes remain unsatisfactory
Detailed Description:
Recurrent vitreous hemorrhage following pars plana vitrectomy PPV for proliferative diabetic retinopathy remains a significant challenge with high incidence and negative impact on visual outcomes Despite various treatments intravitreal bevacizumab IVB has shown potential in reducing post-operative vitreous hemorrhage PO-VH This study aims to determine the efficacy and safety of intraoperative IVB in preventing PO-VH in patients undergoing vitrectomy for diabetic vitreous hemorrhage This prospective randomized controlled trial compared patients receiving intraoperative IVB to a control group The primary outcome was PO-VH incidence at one month with secondary outcomes including visual acuity change time to VH clearance and safety Outcome assessors were masked to the study treatment Data on demographics medical history visual acuity VH grading intraoperative findings and postoperative complications will be collected Statistical analysis compared PO-VH incidence and other outcomes between groups This study will provide valuable evidence on the efficacy and safety of intraoperative IVB in preventing PO-VH contributing to improved clinical practice and patient outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None