Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-02 @ 5:33 AM
Study NCT ID:
NCT03452657
Status:
UNKNOWN
Last Update Posted:
2018-03-02
First Post:
2018-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Clinical Study of Anti-VEGF Treatment on High Risk Diabetic Retinopathy (DR)
Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Organization:
Study Overview
Official Title:
Multicenter Clinical Study of Anti-VEGF Treatment on High Risk Diabetic Retinopathy (DR)
Status:
UNKNOWN
Status Verified Date:
2018-03
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:
The purpose of this study is to determine the efficacy and safety of intravitreous ranibizumab treatment versus sham injections for prevention of high-risk DR.
Detailed Description:
This study is a randomized, double-blind, multi-center, sham-controlled clinical trial. In this trial, 118 subjects will be enrolled. Subjects with signed informed consent are screened and assigned randomly (1:1) to one of the following parallel groups: Group A-Intravitreous 0.5 mg ranibizumab injections and Group B-sham injections. All participants have visits at 0 month, 1 month, and 2 months, followed by visits every 3 months thereafter through 1 year. The main efficacy and safety outcomes assessment will be finished at the end of 12 months.
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?:
True
Is an FDA AA801 Violation?: