Treatment of Bevacizumab and Triamcinolone in Treatment or Macular Edema Secondary to CRVO (MECROV)

November 30, 2007 updated by: Asociación para Evitar la Ceguera en México

Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion

Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Comparison of two groups with different treatment with registrations of outcome in BCVA and complications

Study Type

Interventional

Enrollment (Anticipated)

10

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

  • Mexico
    • Coyoacan
      • Mexico city, Coyoacan, Mexico, 04030
        • Recruiting
        • Asociación Para Evitar la Ceguera en México
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Macular edema secondary to central retinal vein occlusion
  • BCVA worse than 20/40
  • Central macular >250 mc with OCT

Exclusion Criteria:

  • Diabetic retinopathy or other retinopathy
  • Media opacity that does not allow following
  • steroid responder
  • diagnosed glaucoma or IOP > 21 mmHg

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Best corrected visual acuity and macular edema measured with OCT
Time Frame: Follow up to 3 , 6 and 12 months
Follow up to 3 , 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Report treatment complications
Time Frame: 12 month
12 month

Collaborators and Investigators

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

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Principal Investigator: Carmen Gonzalez-Mijares, Physician, Asociación Para Evitar la Ceguera en México
  • Study Director: Hugo Quiroz-Mercado, Retinologyst, Asociación Para Evitar la Ceguera en México
  • Study Chair: Juan Manuel Jimenez Sierra, Retinologyst, Asociación Para Evitar la Ceguera en México
  • Study Chair: MA Martinez-Castellanos, Physician, Asociación Para Evitar la Ceguera en México
  • Study Chair: Octavio Burgos Vejar, Physician, Asociación Para Evitar la Ceguera en México
  • Study Chair: Raul Velez-Montoya, Physician, Asociación Para Evitar la Ceguera en México
  • Study Chair: Ma de Lourdes Lopez Ramos, Physician, Asociación Para Evitar la Ceguera en México
  • Study Chair: Omar Honerlager, preresident, Asociación Para Evitar la Ceguera en México

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

June 1, 2007

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria

November 30, 2007

First Posted (Estimate)

December 4, 2007

Study Record Updates

Last Update Posted (Estimate)

December 4, 2007

Last Update Submitted That Met QC Criteria

November 30, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MECRVO

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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