We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00566761
Recruitment Status : Unknown
Verified November 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : December 4, 2007
Last Update Posted : December 4, 2007
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Condition or disease Intervention/treatment Phase
Macular Edema Central Retinal Vein Occlusion Drug: bevacizumab and triamcinolone Phase 4

Detailed Description:
Comparison of two groups with different treatment with registrations of outcome in BCVA and complications
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined Treatment of Intravitreous Bevacizumab and Triamcinolone for the Treatment or Macular Edema Secondary to Central Retinal Vein Occlusion
Study Start Date : June 2007
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: bevacizumab and triamcinolone
    three applications monthly administrated of bevacizumab 2.5mg for group 1 and bevacizumab 2.5 mg + triamcinolone 4mg first dose followed by two of bevacizumab alone for the group 2

Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes in Best corrected visual acuity and macular edema measured with OCT [ Time Frame: Follow up to 3 , 6 and 12 months ]

Secondary Outcome Measures :
  1. Report treatment complications [ Time Frame: 12 month ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00566761


Contacts
Layout table for location contacts
Contact: Carmen Conzalez-Mijares, Physician 5517638245 cacegomi@hotmail.com

Locations
Layout table for location information
Mexico
Asociacion Para Evitar la Ceguera en Mexico Recruiting
Mexico city, Coyoacan, Mexico, 04030
Contact: Retina Department    5510841400 ext 1171    retinamex@yahoo.com   
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Carmen Cecilia Gonzalez Mijares, Asociación para Evitar la Ceguera en Mexico IAP
ClinicalTrials.gov Identifier: NCT00566761    
Other Study ID Numbers: MECRVO
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: December 4, 2007
Last Verified: November 2007
Keywords provided by Asociación para Evitar la Ceguera en México:
Macular edema
central retinal vein occlusion
bevacizumab
triamcinolone
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Retinal Vein Occlusion
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Triamcinolone
 Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists