Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-03 @ 8:30 AM
Study NCT ID:
NCT04464694
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema
Sponsor:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Organization:
Study Overview
Official Title:
Prospective, Single-blind, Randomised, Controlled, Multi-centre Study to Evaluate the Benefit of Ranibizumab as an Adjunctive Therapy to Vitrectomy for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Oedema
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
NOT_YET_RECRUITING
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:
To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Detailed Description:
Primary Objective: To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.
Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.
Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.
Secondary Objective:To investigate ranibizumab's additional benefit on visual improvement, facilitation of surgery and postoperative outcomes in PDR-DME patients receiving vitrectomy.
Study design: This study is a prospective, randomized, single-blinded, blank-controlled, multi-center clinical trial that requires vitrectomy for PDR-DME patients.
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?: