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

May 29, 2024 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

Terminated

Conditions

Intervention / Treatment

Drug: bevacizumab and triamcinolone

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

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 Locations

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

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

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 (Actual)

June 1, 2007

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

November 30, 2007

First Submitted That Met QC Criteria