Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema

July 7, 2020 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

To investigate ranibizumab's benefit on prevention of early postoperative vitreous haemorrhage in PDR-DME patients receiving vitrectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

142

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 2000831
        • Eye & ENT Hospital of Fudan University
        • Contact:
      • Shanghai, China, 2000892
        • Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China, 315012
        • Ningbo Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age≥18 years old;
  2. Type I or II diabetes mellitus, clinically diagnosed as diabetic macular edema
  3. Diagnosed as proliferative diabetic retinopathy and pas plana vitrectomy (PPV) is required to undergo due to non-absorbent vitreous hemorrhage (VH), fibrovascular proliferation with vitreoretinal adhesions or tractional retinal detachment (TRD); or active severe proliferative retinopathy not responding to previous panretinal laser photocoagulation; as well as other indications of PPV at the investigator's discretion
  4. Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

  1. Pregnancy or lactation;
  2. History of stroke, peripheral vascular disease, angina or myocardial infarction within six months
  3. Intraocular treatment with corticosteroids, anti-vascular endothelium growth factor or intraocular surgery within 45 days preceding baseline;
  4. Clinically confirmed intraocular pressure (IOP) >=21 mmHg, uncontrolled glaucoma or iris neovascularization in either eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ranibizumab
Single intravitreal injection of ranibizumab (0.5 mg) 3~7 days before vitrectomy
Drug: Ranibizumab
Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3~7 days before vitrectomy.
Other Names:
  • Lucentis
Procedure: Pars plana vitrectomy
Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina
Other Names:
  • Vitrectomy
SHAM_COMPARATOR: Sham injection
Sham injection 3~7 days before vitrectomy
Procedure: Pars plana vitrectomy
Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina
Other Names:
  • Vitrectomy
Other: Sham injection
Patients will receive single sham injection 3~7 days before vitrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early postoperative vitreous haemorrhage
Time Frame: From day 1 to week 4 after the vitrectomy
To compare the incidence of the early postoperative vitreous haemorrhage between two arms
From day 1 to week 4 after the vitrectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Best-corrected visual acuity (BCVA) at Month 3
Time Frame: Month 3 after vitrectomy
To compare the changes from baseline BCVA to mean BCVA at month 3 between two arms.
Month 3 after vitrectomy
Mean Best-corrected visual acuity (BCVA) at Month 6
Time Frame: Month 6 after vitrectomy
To compare the changes from baseline BCVA to mean BCVA at month 6 between two arms.
Month 6 after vitrectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Novartis

Investigators

  • Principal Investigator: Peiquan Zhao, Xinhua Hospital Affiliated To Shanghai Jiaotong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

July 5, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (ACTUAL)

July 9, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-20-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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