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

NCT03452657 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2018-03-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ranibizumab

Participants in arm Ranibizumab will receive ranibizumab injection every 4 weeks for the first 3 months, followed by re-injections every 3 months until 1year

PROCEDURE

No drug

Participants in arm Sham-injection will receive sham injection every 4 weeks for the first 3 months, followed by re-injections every 3 months until 1year.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Eye & ENT Hospital of Fudan University

    collaborator OTHER

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    collaborator OTHER

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    collaborator OTHER

  • Shanghai 10th People's Hospital

    collaborator OTHER

  • Shanghai Tongji Hospital, Tongji University School of Medicine

    collaborator OTHER

  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Xun Xu · Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2019-06-30
Completion
2020-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452657 on ClinicalTrials.gov