Efficacy, Safety and Tolerability of Repeated Dosis of Intravitreous Bevacizumab in Uveitic Macular Oedema (EBEV)

March 22, 2012 updated by: Hospital Clinic of Barcelona

Open , Randomized Study About Efficacy, Safety and Tolerability od Repeated Dosis of Intravitreous Bevacizumab in Patients With Uveitic Macular Oedema

The purpose of this study is to determine whether intravitreous bevacizumab or intravitreous triamcinolone acetonide are effective and safe in the treatment of uveitic macular oedema

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

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

  • Spain
    • Spain/ Baleares
      • palma de Mallorca, Spain/ Baleares, Spain, 07014
        • Hospital de Son Dureta
    • Spain/ Com. Valenciana
      • Alicante, Spain/ Com. Valenciana, Spain, 03016
        • Instituto Vissum Alicante
    • Spain/ catalonia
      • Barcelona, Spain/ catalonia, Spain, 08025
        • Hospital Santa Creu i Sant Pau
    • Spain/Catalonia
      • Barcelona, Spain/Catalonia, Spain, 08035
        • Hospital Vall d'Hebron
      • Barcelona, Spain/Catalonia, Spain, 08036
        • Hospital Clinic of Barcelona

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:

  • adult patients with uveitis or retinal vasculitis with unilateral or bilateral macular oedema
  • with macular thickness > 250 micra using OCT
  • visual acuity at least 20/200
  • with stable treatment with oral prednisone at least during 3 months, either oral ciclosporin or other immunomodulator to treat intraocular inflammatory disease
  • patient that can follow study's requirements
  • patient who consents to participate

Exclusion Criteria:

  • presence of corneal or crystalline opacity preventing observation of fundus of eye
  • patients requiring ocular surgery in next 3 months
  • one-eyed
  • pregnancy and child breastfeeding
  • previous history of glaucoma
  • on treatment woth an experimental ocular drug
  • previous thromboembolism or receiving oral anticoagulant treatment
  • vitrectomy
  • patients with proved tractional macular pathology associated to macular oedema

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bevacizumab
intravitreous bevacizumab 2,5 mg at baseline, week 4 and 8. reinjection is required.
Drug: bevacizumab
2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
Experimental: triamcinolone acetonide
intravitreous triamcinolone 2 mg, frequency: 3 months
Drug: triamcinolone acetonide
2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Macular Thickness Measurements Using Stratus Optical Coherence Tomography
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
visual acuity
Time Frame: 48 weeks
48 weeks
intraocular pressure
Time Frame: 48 weeks
48 weeks
opacity crystalline
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

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

Sponsor

Hospital Clinic of Barcelona

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

April 1, 2010

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

March 23, 2012

Last Update Submitted That Met QC Criteria

March 22, 2012

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBEV

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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