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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00566761
First Posted: December 4, 2007
Last Update Posted: December 4, 2007
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.
Information provided by:
Asociación para Evitar la Ceguera en México
  Purpose
Treatment of macular edema secondary to central retinal vein occlusion is more effective with combined therapy of bevacizumab and triamcinolone than bevacizumab alone.

Condition Intervention Phase
Macular Edema Central Retinal Vein Occlusion Drug: bevacizumab and triamcinolone Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Asociación para Evitar la Ceguera en México:

Primary Outcome Measures:
  • 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:
  • Report treatment complications [ Time Frame: 12 month ]

Estimated Enrollment: 10
Study Start Date: June 2007
Estimated Study Completion Date: March 2008
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
Detailed Description:
Comparison of two groups with different treatment with registrations of outcome in BCVA and complications
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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
Contact: Carmen Conzalez-Mijares, Physician 5517638245 cacegomi@hotmail.com

Locations
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
Principal Investigator: Carmen Gonzalez-Mijares, Physician APEC
Study Director: Hugo Quiroz-Mercado, Retinologyst APEC
Study Chair: Juan Manuel Jimenez Sierra, Retinologyst APEC
Study Chair: MA Martinez-Castellanos, Physician APEC
Study Chair: Octavio Burgos Vejar, Physician APEC
Study Chair: Raul Velez-Montoya, Physician APEC
Study Chair: Ma de Lourdes Lopez Ramos, Physician APEC
Study Chair: Omar Honerlager, preresident APEC
  More Information

Responsible Party: Carmen Cecilia Gonzalez Mijares, Asociación para Evitar la Ceguera en Mexico IAP
ClinicalTrials.gov Identifier: NCT00566761     History of Changes
Other Study ID Numbers: MECRVO
First Submitted: November 30, 2007
First Posted: December 4, 2007
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:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors