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Intravitreal Bevacizumab for Age-Related Macular Degeneration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 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:
NCT00347165
First received: June 29, 2006
Last updated: June 30, 2006
Last verified: June 2006
History of Changes
  Purpose

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 Intervention Phase
Age Related Macular Degeneration
 Drug: bevacizumab intravitreal injection
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab Therapy for Neovascular Age-Related Macular Degeneration: A Pilot Study

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • Improvement of visual acuity at 6 months

Secondary Outcome Measures:
  • Retinal thickness at 6 months
  • Leakiness in fluorangiography at 6 months

Estimated Enrollment: 50
Study Start Date: September 2005
Estimated Study Completion Date: September 2006
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347165

Locations
Mexico
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
Investigators
Study Chair: Hugo Quiroz-Mercado, MD Asociacion para evitar la ceguera en Mexico
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00347165     History of Changes
Other Study ID Numbers: AvastinDMRE
Study First Received: June 29, 2006
Last Updated: June 30, 2006
Health Authority: Mexico: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013