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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 because the information has not been verified recently.
Verified November 2007 by Asociación para Evitar la Ceguera en México.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00566761
First received: November 30, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Edema
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Report treatment complications [ Time Frame: 12 month ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 30, 2007
Last Updated: November 30, 2007
Health Authority: Mexico: Ethics Committee

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
Triamcinolone hexacetonide
Triamcinolone
 Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013