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Intravitreal Bevacizumab for Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT00347165
Recruitment Status : Unknown
Verified June 2006 by Asociación para Evitar la Ceguera en México.
Recruitment status was:  Recruiting
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
Information provided by:
Asociación para Evitar la Ceguera en México

Brief Summary:
The purpose of this study is to determine whether intravitreal injection of bevacizumab is effective in the treatment of neovascular age related macular degeneration

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: bevacizumab intravitreal injection Phase 2

Detailed Description:

The neovascular age related macular degeneration(AMD) is a important cause of legal blindness in adults older than 50 years. Currently the treatment is photodynamic therapy that offer stabilization and limited visual improvement after 2 years of therapy. Bevacizumab has been reported effective used as intravenous injection for AMD. But serious side effects have been reported with the use of this drug in oncologic patients. The intravitreal use has been reported in limited case reports and safety and efficacy should be determined.

The purpose of this study is efficacy and safety of 2.5 mg intravitreal of bevacizumab for AMD

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab Therapy for Neovascular Age-Related Macular Degeneration: A Pilot Study
Study Start Date : September 2005
Estimated Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Primary Outcome Measures :
  1. Improvement of visual acuity at 6 months

Secondary Outcome Measures :
  1. Retinal thickness at 6 months
  2. Leakiness in fluorangiography at 6 months

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age >50 age related macular degeneration

Exclusion Criteria:

  • moderate to severe cataract glaucoma intraocular surgery diabetes mellitus non controlled hypertension coronary artery disease

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): NCT00347165

Hospital Luis Sanchez Bulnes Recruiting
MExico city, DF, Mexico, 04030
Contact: Hugo Quiroz-Mercado, MD    525510841400 ext 1171    retinamex@yahoo.com   
Sponsors and Collaborators
Asociación para Evitar la Ceguera en México
Study Chair: Hugo Quiroz-Mercado, MD Asociación para Evitar la Ceguera en México

ClinicalTrials.gov Identifier: NCT00347165     History of Changes
Other Study ID Numbers: AvastinDMRE
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: June 2006

Keywords provided by Asociación para Evitar la Ceguera en México:
macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents