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Multicenter Clinical Study of Anti-VEGF Treatment on High Risk Diabetic Retinopathy (DR)

Diabetic Retinopathy Clinical Trial

Official title:
Multicenter Clinical Study of Anti-VEGF Treatment on High Risk Diabetic Retinopathy (DR)

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03452657
Study type Interventional
Source Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Contact Kun Liu
Phone +86 18917989522
Email drkunliu@sjtu.edu.cn
Status Not yet recruiting
Phase Phase 3
Start date April 2018
Completion date June 2020
View Details
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