Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

December 3, 2009 updated by: University of Campania "Luigi Vanvitelli"
The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • vitreous haemorrhage
  • tractional retinal detachment
  • active proliferative diabetic retinopathy.

Exclusion Criteria:

  • neovascular glaucoma
  • cataract
  • combined traction and rhegmatogenous RD

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: sham
Other: sham
Active Comparator: 7 days
Drug: Bevacizumab
Active Comparator: 20 days
Drug: Bevacizumab

Collaborators and Investigators

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

Sponsor

University of Campania "Luigi Vanvitelli"

Collaborators

Napoli CTO Hospital

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 Registration Dates

First Submitted

December 3, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

December 4, 2009

Last Update Submitted That Met QC Criteria

December 3, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IVBDRNA

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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Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
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