Bevacizumab for Central Retinal Vein Occlusion Study

November 21, 2011 updated by: Anders Kvanta

A Prospective, Randomized, Controlled Study on Intravitreal Bevacizumab (Avastin) for Central Retinal Vein Occlusion (CRVO)

Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Sweden
      • Stockholm, Sweden, 11282
        • St Eriks Eye Hospital

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CRVO with duration < 6 months
  • Visual acuity of 20/800 to 20/50

Exclusion Criteria:

  • CRVO with duration of > 6 months
  • previous treatment with anti-angiogenic drugs

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham injection
Drug: Sham bevacizumab injection
Sham intravitreal injection
Active Comparator: Intravitreal bevacizumab
Drug: bevacizumab
Intravitreal injection of 1.25 mg bevacizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients gaining 15 ETDRS letters or more
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in foveal thickness
Time Frame: 6 months
6 months
Cases of neovascular glaucoma
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Anders Kvanta

Investigators

  • Principal Investigator: Anders Kvanta, MD, PhD, St Eriks Eye Hospital

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

May 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACRVO

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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